Met International Headache Society Criteria Research Articles

Lasmiditan for single migraine attack in Japanese patients with cardiovascular risk factors: subgroup analysis of a phase 2 randomized placebo-controlled trial

ABSTRACT Background Some migraine treatments are contraindicated for patients with cardiovascular disease (CVD) or risk factors (CVRFs). We report safety and efficacy of lasmiditan, a new oral acute migraine treatment with no cardiovascular contraindication, in Japanese patients with CVRFs. Research design and methods MONONOFU was a multicenter, randomized, double-blind, placebo-controlled, phase 2 study of Japanese patients with migraine (met International Headache Society criteria, Migraine Disability Assessment score ≥11, disabling migraine for ≥1 year). Eligible patients were randomized (7:3:7:6) to placebo or lasmiditan 50, 100, 200 mg. This prespecified analysis described CVDs, CVRFs, and cardiovascular treatment-emergent adverse events (TEAEs). Efficacy (proportion pain-free, experienced pain relief, most bothersome symptom-free, or disability-free 2 hours post-dose) was evaluated within CVRF subgroups (≤1, ≥2). Results Of 846 randomized patients, 691 were analyzed (CVRF≤1: 375; CVRF≥2: 316). The proportion of lasmiditan-treated patients with ≥1 TEAE was not related to CVRF numbers. Eighteen (3.8%) lasmiditan-treated and three (1.4%) placebo-treated patients reported likely cardiovascular TEAEs. Lasmiditan was more effective than placebo at relieving pain, symptoms, and disability in both CVRF subgroups. There was no consistent relationship between CVRF subgroups and efficacy. Conclusions Lasmiditan was well tolerated and effective in Japanese patients with migraine and CVRFs. Trial registration ClinicalTrials.gov: NCT03962738.

Paranasal sinus air suction for immediate pain relief of acute migraine \u2013 a randomized, double blind pilot study

BackgroundMigraine is a primary headache disorder, which cause significant disability in adolescence. This double blind, randomized clinical trial assessed the immediate effects of suction of paranasal sinus air during an acute migraine episode.MethodsA randomized, double blind study was conducted with 56 selected Sri Lankan school children of 16–19 years of age. Participants who met International Headache Society criteria for migraine (with or without aura) were included in the study. Subjects were randomly allocated into 2 groups where one group was subjected to three intermittent 10 sec paranasal air suctions with a ten sec suction free interval between two suctions for each nostril and the other group was subjected to placebo air suction (no paranasal air suction) in similar arrangement. Severity of headache and sub–orbital tenderness before and after suction were recorded using standard pain rating scale.ResultsAfter dropouts, treated and placebo groups consisted of 27 and 23 subjects respectively. The mean headache pain score drop in the treated group was significantly higher compared to that of the control group. Moreover, there was a difference in the treatment response between the types of headache (with or without aura). With respect to tenderness there was a statistically significant drop in the treated group compared to the control. In general, airflow rates in left and right nostrils were different in these subjects. However such difference was not seen in the tenderness on two sides. Nevertheless it was revealed that airflow rate has a slight negative correlation with the tenderness irrespective of the side.ConclusionSixty–second paranasal air suction can provide an immediate pain relief for acute migraine in adolescents. We did not assess pain outcomes beyond 60 s, but the initial responses suggests the need to further study the efficacy of paranasal suction in migraine. A further study is suggested to evaluate the acute effects, efficacy and side effects of paranasal air suction using follow up over a prolong period.Trial registrationSri Lanka Clinical Trials Registry SLCTR/2017/018, 29 Jun 2017. Retrospectively registered.

Does Analgesic Overuse Contribute to Chronic Post-traumatic Headaches in Adolescent Concussion Patients?

BackgroundThe causes of persistent headache following concussion are poorly understood. The objective of this study is to explore analgesic overuse as a potential cause of chronic post-traumatic headache among adolescents referred to a headache clinic following concussion. MethodsA retrospective chart review was conducted of all adolescent concussion patients referred to our pediatric headache clinic over the 16-month period between August 1, 2011, and November 30, 2012. Those patients with chronic post-traumatic headaches of 3-12 months' duration who also met International Headache Society criteria for probable medication-overuse headache were identified. Demographic data, concussion symptoms, and headache features were characterized from the initial evaluation and from follow-up visits. ResultsOf 104 adolescent concussion patients referred during the study period, 77 had chronic post-traumatic headache of 3-12 months' duration. Fifty-four of 77 (70.1%) met criteria for probable medication-overuse headache. Only simple analgesics were overused. Thirty-seven patients (68.5%) had resolution of headaches or improvements to preconcussion headache patterns after discontinuing analgesics; seven (13%) had no change in headaches or worsening of headaches after discontinuing analgesics and 10 (18.5%) did not discontinue analgesics or were lost to follow-up. ConclusionExcessive use of analgesics postconcussion may contribute to chronic post-traumatic headaches in some adolescents. Management of patients with chronic post-traumatic headache should include analgesic detoxification when medication overuse is suspected.

An Open‐Label Trial of a Sumatriptan Auto‐Injector for Migraine in Patients Currently Treated With Subcutaneous Sumatriptan

To assess the ability of patients, during an acute migraine attack, to successfully self-inject a single dose of sumatriptan using a novel sumatriptan auto-injector (Alsuma(®)), and to evaluate the safety, tolerability, and effectiveness of this sumatriptan auto-injector during an acute migraine attack. This sumatriptan auto-injector is a single-use system for the rapid subcutaneous delivery of 6 mg of sumatriptan succinate in the acute management of migraine pain. This auto-injector was developed to address the clinical need for an easy-to-use and rapid-to-administer system that did not require any assembly during the time of an ongoing attack. This was an open-label, phase 3 trial conducted at 10 sites in the USA. Male or female adults, ages 18-60 years old, were eligible for study entry if they met International Headache Society criteria for migraine with or without aura, with at least 2 attacks per month, and if they reported use of subcutaneous injectable sumatriptan on at least 2 occasions within the previous 2 months. During the onset of a migraine attack of moderate-to-severe intensity, patients were asked to administer a 6-mg subcutaneous dose of sumatriptan using the auto-injector. Patients returned to the study site within 72 hours of the migraine for the post-treatment assessment visit. A total of 63 patients met entry criteria and received a dose of study medication (the intent-to-treat sample). Sixty-one patients (96.8%) reported injection in the thigh, and 2 patients (3.2%) reported injection in the arm. On the patient questionnaire, 100% of patients (95% confidence interval [CI] 94.3-100%) "agreed" or "agreed strongly" that the written instructions for the auto-injector were clear and easy to follow (30.2% "agreed"; 69.8% "agreed strongly"); 95.2% of patients (95% CI 86.7-99.0%) found that the auto-injector was easy to use (36.5% "agreed"; 58.7% "agreed strongly"), and 65.1% of patients (95% CI 52.0-76.7%) stated that they preferred the new auto-injector to the traditional auto-injector that they were using prior to study entry (42.9% "agreed"; 22.2% "agreed strongly"). Headache response rate at 2 hours was 93.7% (95% CI 84.5-98.2%), and pain-free rate at 2 hours was 60.3% (95% CI 47.2-72.4%). Pain-free rates at 2 hours were similarly high (58.3%; 95% CI 36.6-77.9%) in the subgroup of patients reporting severe baseline headache pain. Only 1 patient reported use of rescue medication after use of the auto-injector, a single oral dose of sumatriptan 100 mg on the same day. The most frequent adverse event was injection site bruising, reported by 15.9% of patients, and rated in all instance as mild in intensity. The second most frequent adverse event was injection site pain, reported by 6.3% of patients, and rated as mild by all patients except 1, who rated it as moderate in intensity. The majority of injection-experienced patients reported the pre-assembled, single-use sumatriptan auto-injector to be an easy-to-use, preferred treatment for an acute migraine attack. The study found the auto-injector to be safe and well tolerated, with levels of injection site reactions that were mild and infrequent.

Migraine and Motion Sensitivity

This article describes vestibular migraine and motion sensitivity. Migraine headache is often accompanied by dizziness or unsteadiness. A diagnosis of vestibular migraine requires that a patient meet International Headache Society criteria for migraine headache, have episodic or fluctuating symptoms highly suggestive of a balance disorder, have no recognized alternative neuro-otologic diagnosis, and experience migrainous symptoms during episodes of vertigo or imbalance. This article discusses these diagnostic criteria; the epidemiology of vestibular migraine; laboratory abnormalities in vestibular migraine; the pathophysiology of vestibular migraine; the treatment of vestibular migraine; comorbidities and overlap with other neuro-otologic disorders, including basilar artery migraine, Ménière disease, and anxiety disorders; and the genetics of vestibular migraine. This review also discusses motion sickness and motion sensitivity, including their relationship with migraine, pathophysiology, and treatment. Recent findings regarding vestibular migraine include new nomenclature for the disorder, validation of diagnostic criteria, new ideas regarding pathophysiology, and reviews of small treatment trials. Vestibular migraine is becoming the preferred designation for a neuro-otologic disorder with a migrainous etiology that causes dizziness and disequilibrium. Criteria have been established for diagnosing this disorder. Although pathophysiology is as yet uncertain and randomized trials are lacking, treatment recommendations can be made. Motion sickness represents a condition often associated with migraine that can reduce quality of life.

An open-label trial of a sumatriptan auto-injector for migraine

Patients  Male or female outpatients (18−60 years of age) were eligible for study entry if they met International Headache Society criteria for migraine with or without aura,5 with ≥2 attacks per month, and if they reported use of the traditional SC injectable sumatriptan on ≥2 occasions within the previous 2 months.  Patients were excluded from the study if they reported: – The use of monoamine oxidase inhibitors (in the previous 14 days prior to study entry), ergot-containing drugs (in the previous 30 days), or medication for migraine prophylaxis (unless stable use for the previous 3 months). – A history of hemiplegic or basilar migraine. – A history of seizure disorders. – A history of cardiac arrhythmia, uncontrolled hypertension, or coronary artery disease (CAD) (or two or more risk factors for CAD); myocardial infarction, or any cerebrovascular syndrome or peripheral vascular disease. – Hypersensitivity or known contraindication to treatment with sumatriptan. – Any clinically significant medical illness or laboratory abnormalities. – A history of alcohol or substance abuse, or use of any experimental drug within the past month. An Open-Label Trial of a Sumatriptan Auto-Injector For Migraine Stephen H. Landy, MD1; Stewart J. Tepper, MD2; Theodore Wein, MD3; Edward Schweizer, MD4; Elodie Ramos, MSc, PhD5 1Wesley Neurology Clinic, Memphis, TN, USA; 2Neurological Center for Pain, Cleveland Clinic, Cleveland, OH, USA; 3Division of Neurology, Montreal General Hospital, Montreal, Canada; 4Paladin Consulting Group, Princeton, NJ, USA; 5Pfizer Inc., New York, NY, USA

A Double‐Blind Placebo‐Controlled Pilot Study of Sublingual Feverfew and Ginger (LipiGesicTMM) in the Treatment of Migraine

Therapeutic needs of migraineurs vary considerably from patient to patient and even attack to attack. Some attacks require high-end therapy, while other attacks have treatment needs that are less immediate. While triptans are considered the "gold standard" of migraine therapy, they do have limitations and many patients are seeking other therapeutic alternatives. In 2005, an open-label study of feverfew/ginger suggested efficacy for attacks of migraine treated early during the mild headache phase of the attack. In this multi-center pilot study, 60 patients treated 221 attacks of migraine with sublingual feverfew/ginger or placebo. All subjects met International Headache Society criteria for migraine with or without aura, experiencing 2-6 attacks of migraine per month within the previous 3 months. Subjects had <15 headache days per month and were not experiencing medication overuse headache. Inclusion required that subjects were able to identify a period of mild headache in at least 75% of attacks. Subjects were required to be able to distinguish migraine from non-migraine headache. Subjects were randomized 3:1 to receive either sublingual feverfew/ginger or a matching placebo and were instructed but not required to treat with study medication at the earliest recognition of migraine. Sixty subjects treated 208 evaluable attacks of migraine over a 1-month period; 45 subjects treated 163 attacks with sublingual feverfew/ginger and 15 subjects treated 58 attacks with a sublingual placebo preparation. Evaluable diaries were completed for 151 attacks of migraine in the population using feverfew/ginger and 57 attacks for those attacks treated with placebo. At 2 hours, 32% of subjects receiving active medication and 16% of subjects receiving placebo were pain-free (P= .02). At 2 hours, 63% of subjects receiving feverfew/ginger found pain relief (pain-free or mild headache) vs 39% for placebo (P= .002). Pain level differences on a 4-point pain scale for those receiving feverfew/ginger vs placebo were -0.24 vs -0.04 respectively (P= .006). Feverfew/ginger was generally well tolerated with oral numbness and nausea being the most frequently occurring adverse event. Sublingual feverfew/ginger appears safe and effective as a first-line abortive treatment for a population of migraineurs who frequently experience mild headache prior to the onset of moderate to severe headache.

Occipital Neuralgia With and Without Migraine: Difference in Pain Characteristics and Risk Factors

We conducted this study to identify differences in presentation and symptomatology between patients with isolated occipital neuralgia (ON) and patients with ON who also had migraine headache (ON + M). Occipital neuralgia is an uncommon cause of headaches. Very little is known about the pain characteristics and associated features of patients with ON + M and whether these pain characteristics differ from those of patients with isolated ON. We studied 35 consecutive patients presenting with ON to the University of Southern California headache clinic. All patients met International Headache Society criteria for diagnosis of ON. Patients completed a questionnaire designed for this study. We also collected demographic data, including age, gender, and ethnicity. Twenty patients had ON + M and 15 had isolated ON. There was no difference in age, gender or ethnicity between patients with ON + M and those with isolated ON. Patients with ON + M had significantly more complaints of pain traveling to the scalp and presence of scalp tenderness and tingling compared with patients with isolated ON; 25% patients in the ON + M group described the pain as "dull" whereas none of the isolated ON group reported this characteristic. There was higher use of chiropractors and massage therapy in patients from ON + M group than from isolated ON. There may be significant differences in pain characteristics for patients with ON + M and those for patients with isolated ON. The data indicate that patients with migraine should also be screened for symptoms of ON, as there may be similarities in presentation. The clinical implications of distinguishing ON + M and isolated ON include differences in treatment regimen, avoidance of inappropriate use of medical resources, and differences in long-term outcomes.

Impact of pharmacist interventions on seeking of medical care by migraineurs

Objectives: To determine the impact of a pharmacist-led educational intervention on the seeking of medical care from physicians by patients with migraine and identify barriers to migraine care and lapsing from this care.Design: Prospective, multigroup, quasiexperimental.Setting: Duquesne University in Pittsburgh, November 2004 through June 2005.Participants: 100 university employees and students. Information from the initial interview was used to divide the patients into four groups: (1) not a migraineur, (2) migraineur who is currently consulting a physician for care of headaches (current consulter), (3) migraineur who has not consulted with a physician for more than 12 months concerning headaches (lapsed consulter), and (4) migraineur who has never consulted a physician regarding headache (never consulter).Interventions: Verbal counseling by a pharmacist and written education on migraine, as well as self-administered questionnaires.Main outcome measures: Participants' physician consultation rates, perceived barriers to physician consultation, and perceived reasons for lapsing from care. ResultsOf the 100 headache sufferers who participated in the study, 82 met International Headache Society criteria for migraine, of whom 22 were never con- sulters and 20 were lapsed consulters. Cross-tabulation and chi-square statistics did not reveal any statistically significant differences between the never-consulter control and intervention groups for 3-month physician consultation rates or intention to seek consultation during the next 6 months; however, 64% of never consulters contacted their physician or expressed intentions to do so after the intervention. The top three barriers to physician consultation identified were misidentifying migraines as headaches (50%), satisfaction with current treatment (45%), and inconvenience of physician consultation (41%). The top three reasons for lapsing from care were reduced frequency of headache (40%), self-identification of effective therapy (40%), and physician-directed effective therapy (30%). Cross-tabulation and chi-square statistics revealed one significant difference among student/employee groups in their identification of barriers. ConclusionThis study identified barriers associated with migraineur physician consultation behavior and reasons for lapses in care. The role of pharmacists in encouraging migraineur physician consultation should be further examined.

Patient satisfaction with eletriptan in the acute treatment of migraine in primary care

SummaryObjective:The efficxacy of triptans for acute migraine has been well established in clinical trials but not in primary care, where they are most commonly prescribed. The aim of this open-label study was to evaluate the effectiveness of eletriptan 40 mg in primary care, using a patient-weighted satisfaction scale.Methods:Eligible patients met International Headache Society criteria for migraine, with 1–6 attacks per month. Patients completed questionnaires at screening and following a single eletriptan-treated attack. Treatment satisfaction was evaluated using a six-item Medication Satisfaction Questionnaire (MSQ). MSQ item scores were weighted, based on the important score ratings, to yield individualised satisfaction scores. The primary end-point was the difference in weighted satisfaction scores between the patient's previous treatment and eletriptan 40 mg. Secondary end-points assessed quality of life (QOL), functioning and efficacy of treatment.Results:Of 590 patients screened, 437 completed the study. Degree (95.2%), time (88.8%) and duration (83.8%) of headache pain relief were rated as most important by patients. The mean (±SD) total satisfaction score on the MSQ was higher for eletriptan than previous therapy (2.2 ± 3.0 vs. 0.6 ± 2.4; p < 0.001). The high level of satisfaction with eletriptan vs. previous treatment reflects the improvements in QOL and functioning observed, and the high headache and pain-free response rates.Conclusions:Patient-weighted satisfaction with eletriptan 40 mg was higher than with previous treatment for all items. The use of patient-weighted importance ratings of satisfaction is a promising approach for establishing effectiveness of treatment in primary care.

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A Practical Approach to Headache Treatment

The World Health Organization cites migraine headache as one of the 20 most disabling medical conditions. This article focuses on the diagnosis and treatment of the primary headache disorders, with special emphasis on migraine, the headache most likely to bring patients to physicians and pharmacists. This review begins with the warning signs of the ominous headache, which, although rare, can herald a life-threatening condition. Clinical characteristics of the primary headache types, migraine, tension-type headache, and cluster headache, are described. Although many individuals believe their headaches are “sinus,” or “stress or tension-induced,” most of the characteristics of these types of headaches actually meet International Headache Society criteria for migraine. Treatments of primary headaches, including acute therapies, abortive agents, and prophylactic medications, are uniquely specific for each headache syndrome. Chronic daily headache patients compose only 4% of the population yet make up the largest percentage of patients who seek treatment at specialty headache centers. Medication-overuse headache, the syndrome in which medications taken for the relief of headache actually foster future headaches, offers a particular challenge to health care providers, as does narcotic use in headache therapy. Complementary and alternative treatments proven efficacious in the treatment of primary headache are also described.

Efficacy of sumatriptan tablets in migraineurs self-described or physician-diagnosed as having sinus headache: A randomized, double-blind, placebo-controlled study

Background: Many patients and physicians interpret episodic headache in the presence or absence of nasal symptoms as “sinus’ headache, while ignoring the possible diagnosis of migraine. Objective: The purpose of this study was to assess the efficacy and tolerability of sumatriptan succinate 50-mg tablets in patients with migraine presenting with “sinus” headache. Methods: A randomized, double-blind, placebo-controlled, multicenter study was conducted in adult (aged 18–65 years) migraine patients presenting with self-described or physician-diagnosed “sinus” headache. From November 2001 to March 2002, patients meeting International Headache Society criteria for migraine (with ≥2 of the following: unilateral location, pulsating quality, moderate or severe intensity, aggravation by moderate physical activity; and ≥1 of: phonophobia and phonophobia, nausea and/or vomiting) and with no evidence of bacterial rhinosinusitis were enrolled and randomized in a 1:1 ratio via computer-generated randomization schedule to receive either 1 sumatriptan 50-mg tablet or matching placebo tablet. The primary efficacy end point was headache response (moderate or severe headache pain reduced to mild or no headache pain) at 2 hours after administration. The presence or absence of migraine-associated symptoms and sinus and nasal symptoms was also measured. Tolerability was assessed through patient-reported adverse events (AEs). Results: Two hundred sixteen patients with self-described or physician-diagnosed “sinus” headache received a migraine diagnosis and treated 1 migraine attack with sumatriptan 50 mg. The efficacy (intentto-treat) analysis included 215 patients treated with sumatriptan 50 mg (n = 108; mean [SD] age, 39.6 [12.3] years; mean [SD] weight, 77.7 [17.7] kg; sex, 71% female; race, 69% white) or placebo (n = 107; mean [SD] age, 41.0 [11.3] years; mean [SD] weight 80.7 [20.9] kg; sex, 69% female; race, 64% white). Significantly more patients treated with sumatriptan 50 mg achieved a positive headache response at 2 and 4 hours after administration compared with those treated with placebo (69% vs 43% at 2 hours and 76% vs 49% at 4 hours, respectively; both, P < 0.001). Significantly more sumatriptan-treated patients were free from sinus pain compared with placebo recipients at 2 hours (63% vs 49% placebo, P = 0.049) and 4 hours (77% vs 55%, P = 0.001). All treatments were generally well tolerated. The most common drug-related AEs reported in the sumatriptan and placebo groups, respectively, were dizziness (5% vs < 1%), nausea (3% vs 2%), other pressure/tightness (defined as sense of heaviness; heaviness of upper body, upper extremities; jaw tension; neck tension) (4% vs 0%), and temperature sensations (defined as warm feeling of back of neck, or flushing) (2% vs 0%). No patients experienced any serious AEs. Conclusions: Sumatriptan 50-mg tablets were effective and generally well tolerated in the treatment of these patients presenting with migraine headaches that were self-described or physician-diagnosed as sinus headaches.

Efficacy and tolerability of sumatriptan injection for the treatment of morning migraine: Two multicenter, prospective, randomized, double-blind, controlled studies in adults

Objective: The aim of this study was to assess the efficacy and tolerability of sumatriptan injection in the treatment of morning migraine. Methods: In 2 multicenter (20 sites for study 1 and 25 sites for study 2), randomized, double-blind, controlled, parallel-group studies, male and female patients aged 18 to 65 years with migraine meeting International Headache Society criteria received SC sumatriptan succinate injection 6 mg or inactive vehicle (control) for the outpatient treatment of a single morning migraine, defined as migraine with moderate or severe pain on awakening. The primary end point was the percentage of patients who achieved pain-free relief (moderate or severe pain reduced to no pain) at 2 hours after treatment. Tolerability was assessed using spontaneous reporting or noted by a clinician during the studies, assessed at the return visit. Results: The efficacy analysis included, in the succinate group, 145 patients in study 1, 148 in study 2; control, 152 in study 1, 139 in study 2. The mean (SD) ages in the sumatriptan group were 40.2 (9.7) and 38.8 (10.1) years in studies 1 and 2, respectively; control, 41.4 (10.4) and 39.3 (9.7) years. The majority of patients in the 2 studies were female (sumatriptan, 84% and 93% in studies 1 and 2, respectively; control, 82% and 81%) and white (sumatriptan, 83% and 81%; control, 78% and 89%). Two hours after treatment, 48% and 57% of patients treated with sumatriptan injection compared with 18% and 19% of control patients reported pain-free relief in studies 1 and 2, respectively (both, P < 0.001). Two hours after treatment, 72% and 77% of patients treated with sumatriptan injection reported headache relief (moderate or severe pain reduced to mild or no pain) compared with 32% and 41% of control patients (both, P < 0.001). Onset of efficacy versus control (the first time point with statistical significance of pain relief) was observed beginning 10 minutes postdose ( P < 0.05 sumatriptan injection vs placebo across pooled studies). Mean time to efficacy in the sumatriptan group was 10 minutes ( P < 0.05 vs controls). The most commonly reported adverse events were nausea (sumatriptan, 6% and 4%; control, 2% and 2%) and injectionsite reaction (ie, burning or stinging at the injection site) (sumatriptan, 5 % and 5%; control, 2% and 1%). Injection-site reaction was also the only adverse event considered treatment related and reported in ≥5 % of all patients. Conclusion: The results of these 2 randomized, double-blind, controlled studies suggest that sumatriptan injection was effective and well tolerated in the acute treatment of morning migraine in these adults.

Eletriptan in Migraine Patients Reporting Unsatisfactory Response to Rizatriptan

The objective of this open-label study was to evaluate the efficacy of switching patients who had a previous unsatisfactory response to rizatriptan to eletriptan 40 mg. Background.-The characteristics of individual migraine patients can vary tremendously and can have a significant impact on treatment outcomes. In addition, clinical experience has demonstrated that the triptans are not identical or interchangeable and that patients who respond poorly or who are dissatisfied with one agent can derive benefit by being switched to another agent within the triptan class. Patients were eligible if they met International Headache Society criteria for migraine, with a frequency of 1 to 6 migraine attacks per month, and had documented "unsatisfactory treatment response" to rizatriptan within the past year (54% on the melt formulation; 46% on tablets). Reasons for dissatisfaction with rizatriptan (>1 could be cited) included inadequate (84%) or slow onset (50%) of pain relief, high recurrence rate (69%), and lack of improvement in associated symptoms (60%). One hundred twenty-three patients were eligible for treatment. Patients were instructed to take eletriptan 40 mg as soon as they were certain that their headache was a migraine, regardless of level of pain severity (8% treated headaches that were mild). Headache response at 2 hours (first-attack data) was 64%. Absence of nausea (from baseline to 2 hours) increased from 50% to 78%, absence of photophobia from 30% to 72%, and absence of phonophobia from 39% to 77%. Functional response at 2 hours was 63%, with 41% of patients reporting normal functioning. Treatment with eletriptan 40 mg was associated with a 27% to 40% reduction in migraine attack-related functional impairment, as measured by the PQ-7. Recurrence rates were 36.6%. Overall, 72% of patients rated eletriptan as a "good-to-excellent" treatment, and 78% reported overall satisfaction with the degree of headache relief. The results of this study suggest that eletriptan is an efficacious treatment option for patients who are dissatisfied with their response to rizatriptan.

Eletriptan in the Early Treatment of Acute Migraine: Influence of Pain Intensity and Time of Dosing

This double-blind, placebo-controlled study was designed to evaluate the efficacy and tolerability of early treatment of a single migraine attack, when headache pain was mild, with two doses (20 mg and 40 mg) of eletriptan. Patients (N = 613; female 79%; mean age 39 years) meeting International Headache Society criteria for migraine were encouraged, but not required, to utilize early treatment, thus providing an opportunity to assess the relative contribution to efficacy of pain severity and timing of dose. For the total patient sample (mild-to-severe headaches), 2-h pain-free rates were significantly higher than placebo (22%) on both eletriptan 20 mg (35%; P < 0.01) and eletriptan 40 mg (47%; P < 0.0001). For the cohort of patients who treated their headache when the pain intensity was mild, the 2-h pain-free rate on eletriptan 40 mg was 68% compared with 25% on placebo (P < 0.0001). Pain intensity at the time of taking eletriptan appeared to influence outcome more than the timing of the dose relative to headache onset. Eletriptan was well-tolerated, with adverse event rates similar to placebo when mild headaches were treated.

A Randomized Prospective Placebo-Controlled Study of Intravenous Magnesium Sulphate vs. Metoclopramide in the Management of Acute Migraine Attacks in the Emergency Department

The objective of this randomized, placebo-controlled, double-blind study was to determine the effectiveness of intravenous magnesium sulphate and intravenous metoclopramide in the treatment of acute migraine attacks in the Emergency Department when compared with placebo. Adult patients who presented to the Emergency Department with a headache that met International Headache Society (IHS) criteria for acute migraine were infused with either 10 mg of intravenous metoclopramide, 2 g of intravenous magnesium sulphate or normal saline over 10 min. At 0, 15, and 30 min, patients were asked to rate their pain on a standard visual analogue scale. At 30 min, patients were asked in a standard manner about the need for rescue medication. Adverse affects were also recorded. Patients were followed up by telephone within 24 h for any recurrence after discharge. The primary endpoint of the study was the difference in pain relief between the groups at 30 min. Of the 120 patients who met IHS criteria, seven were excluded from the study due to insufficient data. The number of patients, gender, age and initial visual analogue scale (VAS) scores were comparable between groups. Each group experienced more than a 25-mm improvement in VAS score at 30 min. However, there was no significant difference detected in the mean changes in VAS scores for pain. The rescue medication requirement was higher in the placebo group. The recurrence rate in 24 h was similar between the groups. Although patients receiving placebo required rescue medication more than the others, metoclopramide and magnesium have an analgesic effect similar to placebo in migraine attacks.

Petasites hybridus root (butterbur) is an effective preventive treatment for migraine

To evaluate the clinical efficacy of a standardized special root extract from the plant Petasites hybridus as a preventive therapy for migraine. This is a three-arm, parallel-group, randomized trial comparing Petasites extract 75 mg bid, Petasites extract 50 mg bid, or placebo bid in 245 patients with migraine. Eligible patients met International Headache Society criteria for migraine, were ages 18 to 65, and had at least two to six attacks per month over the preceding 3 months. The main outcome measure was the decrease in migraine attack frequency per month calculated as percentage change from baseline over a 4-month treatment period. Over 4 months of treatment, in the per-protocol analysis, migraine attack frequency was reduced by 48% for Petasites extract 75 mg bid (p = 0.0012 vs placebo), 36% for Petasites extract 50 mg bid (p = 0.127 vs placebo), and 26% for the placebo group. The proportion of patients with a > or =50% reduction in attack frequency after 4 months was 68% for patients in the Petasites extract 75-mg arm and 49% for the placebo arm (p < 0.05). Results were also significant in favor of Petasites 75 mg at 1, 2, and 3 months based on this endpoint. The most frequently reported adverse reactions considered possibly related to treatment were mild gastrointestinal events, predominantly burping. Petasites extract 75 mg bid is more effective than placebo and is well tolerated as a preventive therapy for migraine. Petasites 50 mg PO bid was not significantly more effective than placebo on the primary study endpoints.

An open-label study to assess changes in efficacy and satisfaction with migraine care when patients have access to multiple sumatriptan succinate formulations

Background: Because a patient's migraines often differ in duration, intensity, and accompanying symptoms, as well as the conditions and circumstances at the time of the headache, the mode for treatment also may change. Objective: The goal of this study was to determine whether migraine management is improved by providing 3 formulations of sumatriptan succinate to patients, together with education to assist them in selecting the most appropriate formulation for specific attacks. Methods: This was an open-label study conducted in 3 family practice settings. Patients were recruited who had at least a 1-year history of migraine meeting International Headache Society criteria and experienced 2 to 6 attacks per month within the previous 3 months. Patients received instructions on oral, intranasal, and subcutaneous (SC) sumatriptan and were provided with all 3 formulations to treat 6 headaches. Migraine features, formulation used, reason for selecting specific formulation, migraine symptom relief, and use of follow-up doses were recorded in diaries. At follow-up, patients completed a questionnaire assessing satisfaction with access to multiple formulations. Results: Of the 33 enrolled patients (26 women, 7 men; mean age, 38.5 years [range, 23–54 years]), 25 (75.8%) completed all visits. Of 149 headaches treated, 39 (26.2%) were mild at onset, 70 (47.0%) were moderate, and 40 (26.8%) were severe. Eighty (53.7%) headaches were treated with tablets, 35 (23.5%) with nasal spray, and 34 (22.8%) with SC injection. Primary reasons for selecting specific formulations included “fewer side effects” for tablets, “convenience” for nasal spray, and “quick onset of action” for SC injection. Twenty-one (84.0%) patients reported being either very satisfied or satisfied with their ability to manage their headaches. Physicians reported that 18 of 24 (75.0%) patients had an improved attitude toward managing their headaches. All formulations were well tolerated. Eight (32.0%) patients reported adverse events, the 2 most common being chest pressure and fatigue. Conclusion: The patients in this study reported greater satisfaction with migraine management when given access to multiple sumatriptan formulations and education regarding their appropriate use.

Randomized clinical trial of intravenous magnesium sulfate as an adjunctive medication for emergency department treatment of migraine headache

Study Objective: We test the hypothesis that intravenous magnesium sulfate is an effective adjunctive medication for treatment of acute migraine. Methods: In this randomized, double-blind, placebo-controlled trial, adults presenting to 2 urban emergency departments with headache meeting International Headache Society criteria for acute migraine received either 20 mg of intravenous metoclopramide plus 2 g of intravenous magnesium sulfate or 20 mg of intravenous metoclopramide plus a placebo of intravenous saline solution at 15-minute intervals for a maximum of 3 doses or until pain relief occurred. At 0, 15, 30, and 45 minutes, patients recorded pain intensity using a standard visual analog scale (VAS). The primary study end point was the between-group difference in pain improvement when initial and final VAS scores were compared. Results: Of 44 patients enrolled (21 randomized to metoclopramide plus magnesium and 23 to metoclopramide plus placebo), 42 (95%) were women. Baseline features were comparable in both groups. Each group experienced a more than 50-mm improvement in VAS score during the study. However, this improvement was smaller in the magnesium group for the primary end point (16-mm difference favoring placebo [95% confidence interval (CI) –2 to 34 mm]), as was the proportion with normal functional status at their final rating (36% absolute difference also favoring placebo [95% CI 7% to 65%]). Using a 50% reduction in pain to dichotomize VAS scores, the number needed to harm with magnesium plus metoclopramide versus metoclopramide alone is 4 patients (95% CI 2 to 36). Conclusion: Although this result was unexpected, our data suggest that the addition of magnesium to metoclopramide may attenuate the effectiveness of metoclopramide in relieving migraine. Countertherapeutic cerebral vasodilatation caused by magnesium is a plausible, although unproven, explanation for this finding. Because of the preponderance of women in our trial, these data may not be generalizable to men. [Corbo J, Esses D, Bijur PE, Iannaccone R, Gallagher EJ. Randomized clinical trial of intravenous magnesium sulfate as an adjunctive medication for emergency department treatment of migraine headache. Ann Emerg Med. December 2001;38:621-627.]