Treatment Of Migraine In Adolescents Research Articles

Remote electrical neuromodulation (REN) wearable device for adolescents with migraine: a real-world study of high-frequency abortive treatment suggests preventive effects.

Migraine is a chronic neurological disease manifesting as attacks of disabling head pain and associated symptoms. Remote electrical neuromodulation (REN) is a non-pharmacological, prescribed, wearable device (Nerivio®). This device has been certified by the FDA for the acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older. The device is affixed to the user's arm during 45-min treatment sessions and is operated using a smartphone app. This study (NCT05769322) aims to evaluate whether frequent use of REN for the acute treatment of migraine in adolescents resulted in a reduction in monthly migraine treatment days (MMTD), as previously demonstrated in adults through a dedicated prevention clinical trial (NCT04828707). The study included real-world prospective data from adolescent patients who used REN on at least 10 days every 28-day month, following the REN migraine prevention guideline of an every-other-day pattern. Additional requirements were at least three REN treatment days in each of the two subsequent months. The number of MMTD was used as a proxy measure for the number of monthly migraine days (MMD). The change in MMTD from the first month, taken as a "baseline," to each of the following months was used to evaluate the presence and size of potential migraine preventive benefits of REN in adolescents. A total of 83 adolescents were eligible for analysis. The users were 15.9 ± 1.3 years of age (mean ± SD), and 89% of them were female. The results demonstrated a substantial month-to-month reduction in the mean (±SD) number of REN treatment days from 12.6 (±3.2) MMTD in the first month to 9.0 (±4.8) MMTD in the second month (p < 0.001), and a further decrease to 7.4 (±4.2) MMTD in the third month (p < 0.001). This indicates an accumulative reduction of 5.2 (±4.8) mean REN MMTD from the first month to the third month of consecutive REN treatment. The users also reported consistent 2-h acute pain responses in at least 50% of their treated attacks, with 61.9% of the users reported experiencing pain relief, 24.5% reported pain freedom, 67.4% indicated relief in functional disability, and 41.3% reported complete freedom from functional disability. The frequent use of REN among adolescents as an acute treatment for migraine attacks resulted in a decrease in the mean number of monthly treatment days in the subsequent months, suggesting that REN may have potential preventive benefits for migraine in this subpopulation.

PRIMARY HEADACHES IN ADOLESCENTS WITH DEPENDENCE ON COMPUTER GAMES AND SOCIAL NETWORKS. APPROACHES TO THE TREATMENT AND PREVENTION OF MIGRAINE IN CHILDREN AND ADOLESCENTS

A review of data on the main types of primary cephalgia in adolescents (headache tension and migraine), their prevalence, classification, clinical manifestations, basic principles of treatment and prevention is presented. The results of our own study, which showed a closer relationship between the frequency of occurrence and clinical features of these types of pathology with the presence of addiction to computer games and social networks in adolescents, are included. Of the 5195 surveyed adolescents, 8.1% had an to social media addiction, 10.5% had a Gaming Addiction, including 7.7% moderate and 2.8% severe. The authors come to the conclusion that it is necessary to analyze the characteristics of Internet use and content consumed by adolescents for early diagnosis, treatment and prevention of primary cephalalgia associated with the presence of gaming addiction and dependence on social networks, highlight approaches to the treatment of migraine in adolescents.

Acute Treatment of Migraine in Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN)

Nearly 10% of children and adolescents in the United States experience migraine. Pharmacologic treatment of migraine in adolescents is limited due to only few US Food and Drug Administration (FDA)-approved medications, limited efficacy, or lack of tolerability. Remote Electrical Neuromodulation (REN) is a nonpharmacologic abortive treatment for migraine, cleared by the FDA for patients aged 12 years and above. This study evaluated real-world efficacy of REN in adolescents aged 12 to 17 years. Real-world data were collected from patients aged 12 to 17 years treated with the REN device (Nerivio) from January 1, 2021, to May 31, 2022. Study's end points included consistent efficacy two hours after treatment, use of REN as a standalone versus as an adjunct therapy, treatment intensity, and safety. Of 1629 adolescents included in the study, consistent response in at least 50% of treatments at two hours posttreatment was achieved by 60.3% of patients for pain relief, 26.3% for pain freedom, 66.3% for functional disability relief, and 41.2% for functional disability freedom. Of 2365 treatments in which medication usage was reported, REN was used as standalone therapy in 64.4% of the treatments, REN was combined with over-the-counter medications in 18.6%, and it was combined with prescription medications in 17%. Mean treatment intensity from 13,716 treatments was 28.5% (±13.6%) of the max stimulator output. Only three device-related adverse events were reported, all minor. This real-world analysis demonstrates the persistent efficacy of REN for abortive treatment of migraine in adolescents, extending findings of prior clinical trials in adolescents and real-world studies in adults.

Acute Treatment of Migraine in Adolescents: Post Hoc Analysis of Remote Electrical Neuromodulation (REN) vs. Standard-care Medications Efficacy (P7-2.001)

Acute Treatment of Migraine in Adolescents: Post Hoc Analysis of Remote Electrical Neuromodulation (REN) vs. Standard-care Medications Efficacy (P7-2.001)

Comparison of Remote Electrical Neuromodulation and Standard-Care Medications for Acute Treatment of Migraine in Adolescents: A Post Hoc Analysis.

There is an unmet need for new, efficacious, well-tolerated, acute treatments for migraine in adolescents. Remote electrical neuromodulation (REN) is a novel, nonpharmacological treatment that provides significant symptom relief with good tolerability. The current post hoc analysis compared the efficacy of REN to that of standard-care medications for the acute treatment of migraine in adolescents. Within-participant post hoc analysis of data from a clinical trial. Data from a clinical trial. Data from 35 adolescent participants were analyzed. Efficacy was compared between a run-in phase, in which attacks were treated with standard-care medications (triptans or over-the-counter medications), and an intervention phase, in which attacks were treated with REN. Efficacy was compared within participants through the use of McNemar's test at four endpoints (2 hours after treatment): single-treatment pain freedom and pain relief, and consistency of pain freedom and pain relief (defined as response in at least 50% of the available first four treatments). At 2 hours after treatment, pain freedom was achieved by 37.1% of the participants with REN, vs 8.6% of the participants with medications (P = 0.004). Pain relief was achieved by 71.4% with REN, vs 57.1% with medications (P = 0.225). Consistency of pain freedom was achieved by 40% with REN, vs 8.6% with medications (P < 0.001). Consistency of pain relief was achieved by 80.0% with REN, vs 57.2% with medications (P = 0.033). Our results suggest that REN may have higher efficacy than certain standard-care medications for the acute treatment of migraine in adolescents. A larger-scale, blinded comparative-effectiveness and tolerability study is needed.

Remote Electrical Neuromodulation for the Acute Treatment of Migraine in Adolescents (1960)

Remote Electrical Neuromodulation for the Acute Treatment of Migraine in Adolescents (1960)

Med Check: Rapid Blood Test for Concussion; REMS for Some Fentanyl Products; Phase 3 for Troriluzole for OCD; Remote Neuromodulation Device for Adolescent Migraine

Back to table of contents Previous article Next article Med CheckFull AccessMed Check: Rapid Blood Test for Concussion; REMS for Some Fentanyl Products; Phase 3 for Troriluzole for OCD; Remote Neuromodulation Device for Adolescent MigraineTerri D’ArrigoTerri D’ArrigoSearch for more papers by this authorPublished Online:10 Feb 2021https://doi.org/10.1176/appi.pn.2021.2.1FDA Approves Rapid Blood Test for ConcussionsIn January the FDA approved Abbott’s i-STAT Alinity handheld device for detecting mild traumatic brain injury (TBI), the company announced. Test results are available within 15 minutes using plasma that is placed into a test cartridge. The test was developed in collaboration with the U.S. Department of Defense.The test measures glial fibrillary acidic protein and ubiquitin carboxyl-terminal hydrolase L1 in blood plasma—two biomarkers that indicate brain injury when they are elevated. According to a statement by the company, the device provides test results with 95.8% sensitivity and greater than 99% negative predictive value. A negative test can rule out the need for a CT scan, and having a blood test available could reduce the number of unnecessary CT scans, according to the company.FDA Toughens REMS for Some Fentanyl ProductsIn December the Food and Drug Administration (FDA) took steps to strengthen the Risk Evaluation and Mitigation Strategy (REMS) program for transmucosal immediate-release fentanyl (TIRF).“To use the TIRF medicines safely, these patients must be opioid tolerant based on concurrent regular use of another opioid medication,” the FDA wrote in a statement. “Despite the decline in the use of TIRF medicines in recent years, data have suggested that prescribing of TIRF medicines still occurs in patients who are not opioid tolerant. With this in mind, the FDA finalized modifications to the REMS program to address the persistence of these concerning prescribing practices.”The TIRF REMS program now requires the following:Prescribers must document a patient’s opioid tolerance with each prescription of a TIRF medicine for outpatient use.Outpatient pharmacies dispensing TIRF medicines must document and verify a patient’s opioid tolerance before dispensing.Inpatient pharmacies must develop internal policies and procedures to verify opioid tolerance in patients who require TIRF medicines while hospitalized.A new patient registry will monitor for accidental exposure, misuse, abuse, addiction, and overdose.Phase 3 Trial Enrollment Begins for Troriluzole for OCDBiohaven has begun enrollment for a phase 3 trial to assess the efficacy and safety of 280 mg troriluzole once per day in patients with obsessive-compulsive disorder (OCD), the company announced in January. The trial will include two double-blind, placebo-controlled studies with approximately 600 patients in each. Troriluzole normalizes synaptic levels of glutamate, a key neurotransmitter implicated in OCD.Biohaven is pressing forward with the phase 3 trial even though troriluzole did not meet its primary endpoint in a previous trial, wherein scores on the Yale-Brown Obsessive-Compulsive Scale for patients who took troriluzole were not statistically significantly better than those who took placebo after 12 weeks. In the previous trial, scores in patients who took troriluzole dropped an average of 5.9 points from baseline, compared with 4.9 points in those who took placebo. However, after eight weeks, there was a 1.5-point gap in scores between the troriluzole group and the placebo group.Remote Neuromodulation Device Shows Promise For Adolescent MigraineA study in Headache suggests that Nerivio, a wearable device approved for treating migraine in adults, may also be helpful in treating the condition in adolescents, manufacturer Theranica announced in December. The device, which is worn with an arm band and controlled through an app on the patient’s smartphone, uses remote electrical neuromodulation to activate the body’s natural ability to modulate pain.Researchers evaluated 45 patients aged 12 to 17 with a history of episodic and chronic migraines who completed at least one treatment with Nerivio. Over the course of the 12-week study, the device treated 159 migraine headaches, 49% of which were moderate and 33% of which were severe at baseline. Two hours after treatment, 71% of participants reported pain relief and 35% reported being free of pain, results that were sustained for 24 hours in 90% of cases. At two hours, 69% of patients experienced improved functional ability, which was defined as the ability to do schoolwork and perform “usual activities.” There were no device-related serious adverse events. ■“Remote Electrical Neuromodulation for Acute Treatment of Migraine in Adolescents” is posted here. ISSUES NewArchived

Safety and Efficacy of Nerivio™ for the Acute Treatment of Migraine in Adolescents

Safety and Efficacy of Nerivio™ for the Acute Treatment of Migraine in Adolescents

Sumatriptan/Naproxen Sodium: A Review in Migraine.

Sumatriptan/naproxen sodium (Treximet®) is a fixed-dose combination of a serotonin 5-HT1B/1D receptor agonist (sumatriptan) and an NSAID (naproxen sodium), approved in the USA for the acute treatment of migraine with or without aura in adolescents and adults. In a randomized, phase 3 trial in adolescents, significantly more sumatriptan/naproxen sodium than placebo recipients were pain-free at 2 h. Similarly, in a pair of randomized phase 3 trials in adults, significantly more sumatriptan/naproxen sodium than placebo recipients had relief from migraine symptoms at 2 h, and the combination was more effective than individual components in terms of sustained (2-24 h) pain-free response rate. Sumatriptan/naproxen sodium was generally well tolerated, with ≤11 % of adolescents and ≤22 % of adults reporting treatment-related adverse events in the key clinical trials. The most common adverse reactions were nasopharyngitis, hot flushes and muscle tightness in adolescents, and dizziness, pain or pressure sensations, nausea, somnolence, dry mouth, dyspepsia and paraesthesia in adults. Based on current data, sumatriptan/naproxen sodium is a useful option for the acute treatment of migraine in adolescents and adults. The fixed-dose combination may reduce pill burden and improve adherence in some patients.

Consistency of response to sumatriptan/naproxen sodium in a randomized placebo-controlled, cross-over study for the acute treatment of migraine in adolescence.

A multi-centered, randomized, placebo-controlled, early intervention, cross-over study was conducted to evaluate the consistency of response of sumatriptan/naproxen sodium 85/500 mg (S/NS) over 4 attacks in the acute treatment of migraine in adolescents. Inclusion of subjects was dependent on their age of 12-17 years, frequency, and history of migraine headaches (1-8 per month) over the previous 6 months prior to screening and generally healthy males and females of non-childbearing potential that were not on excluded medications. Subjects were instructed to treat within 1 hour of pain onset, including when the pain was still mild. Subjects were randomized in a double-blind fashion using a computer-generated randomization list in which the study drug was prepared prior to study start, and subjects were allocated to a number in sequential order for each site. Each site was allocated number blocks in sets of 10 depending of the rate of enrollment. The objective of this study was to examine the efficacy of S/NS vs placebo in the primary end-points of pain-free response at 2 hours (2hPF), 24-hour sustained pain-free response (24hPF), and pain-free response at 2 hours with early intervention (2hPFE) calculated as percentage out of all attacks. In the study, 94 subjects treated 347 attacks in total: treating 277 with S/NS and 70 with placebo. Compared with placebo, S/NS produced higher 2hPF rates (S/NS 37%, placebo 18%; P < .004), and 2hPFE with rates (S/NS 32%, 18% placebo; P < .03). Compared with placebo, 24hPF rates were S/NS 86%, placebo 78%, P < .17, which were higher than placebo but not clinically significant. 2hPF was reported in at least 2 of the 3 migraines treated with S/NS in 40.4% of subjects. 24hPF was reported in at least 2 of the 3 migraine treated with S/NS in 86.2% subjects. Adverse reactions were generally low and comparable between S/NS and placebo.

Long-Term Evaluation of Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents

Long-Term Evaluation of Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents

Amitriptyline for migraine prophylaxis in adolescents

headaches in children and adolescents. Amitriptyline efficacy as a prophylactic treatment for migraine in adults has been widely studied, but there is limited data on its use in children and adolescents.Objective To determine the efficacy of amitriptyline for prophylactic treatment of migraine in adolescents.Methods We conducted a single-blind, randomized, clinical trial study in Medan, North Sumatra, from July to October 2009. All participants had migraines, according to the International Headache Society criteria. They were divided into two groups, receiving either 10 mg amitriptyline or a placebo daily for 3 months. Headache frequency (days per month), headache duration (hours) and information to assess functional disability according to the Pediatric Migraine Disability Assessment Scale (PedMIDAS) were recorded by subjects. Efficacy was measured before, during and after intervention.Results A total of 98 patients, aged 12 – 19 years (mean age 14.7 years) enrolled and were divided into the amitriptyline and placebo groups. Compared with baseline, there were significant differences in headache frequency and PedMIDAS score in the amitriptyline group (P=0.001, 95% CI 2.02 to 2.94 and P=0.001, 95% CI 7.64 to 9.76, respectively), but not in the placebo group (P &gt;0.05) after 3 months of treatment. We also found that amitriptyline significantly decreased headache frequency, duration, and functional disability compared to the placebo, after 3 months of treatment (P &lt; 0.05).Conclusion Amitriptyline was effective for prophylactic treatment of migraine in adolescents after 3 months of intervention.

Long‐Term Evaluation of Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents

To evaluate the long-term safety, tolerability, effectiveness, impact on quality of life, and medication satisfaction of sumatriptan/naproxen sodium in the acute treatment of migraine headache in adolescents. This 12-month, multicenter, open-label, safety study was conducted in adolescents (aged 12-17 years) with an average of 2-8 migraines/month typically lasting >2 hours untreated for >6 months prior to initiation. Subjects were instructed to treat migraines as early as possible and were allowed to rescue 2 hours post dose with a single dose of a naproxen-containing product, over-the-counter pain reliever, or anti-emetics. Subjects were advised not to take a second tablet of sumatriptan/naproxen sodium without at least a 24-hour headache-free period. Safety evaluations included adverse events, laboratory tests, and vital signs and electrocardiogram evaluation. Other evaluations included freedom from pain, quality of life, and medication satisfaction. Of the 656 subjects enrolled, 622 (95%) treated at least 1 migraine with sumatriptan/naproxen sodium, of which 435 (70%) and 363 (58%) completed 6 and 12 months of the study, respectively. Overall, there were 12,927 exposures to sumatriptan/naproxen sodium: on average 2.5 tablets were taken per month per subject. The most common treatment-related adverse events were nausea (7%), dizziness (3%), muscle tightness (3%), and chest discomfort (3%). There were no deaths; 4 subjects had 5 serious adverse events (suicide attempt, hemolytic anemia and syncope, suicidal ideation, spontaneous abortion) unrelated to sumatriptan/naproxen sodium and resolved without sequelae. Seven percent of subjects discontinued participation in the study because of an adverse event; 5% of subjects discontinued due to lack of efficacy. Overall, 42% of the migraine attacks were pain-free within 2 hours of treatment with sumatriptan/naproxen sodium, subjects reported improvements from baseline in 2 of 3 quality of life domains over time, and were generally satisfied with the efficacy and overall treatment at the end of the study. In adolescent migraineurs, after up to 12 months and over 12,000 exposures to sumatriptan/naproxen sodium, there were no new or clinically significant findings in the safety parameters, including the frequency and nature of adverse events, as compared to the individual components or to the adverse event profile in adults. In addition, sumatriptan/naproxen sodium provided freedom from pain over time, improvements in quality of life and medication satisfaction.

Almotriptan for the acute treatment of adolescent migraine

Importance of the field: Migraine is a common problem affecting 10 – 20% of adolescents. Its treatment has three fundamental components: bio-behavioral interventions, preventive measures, and acute drug therapy. In June 2009, the US FDA approved almotriptan, a 5-HT1B/1D receptor agonist, for the acute treatment of migraine in adolescents aged 12 – 17 years – the first ‘triptan’ to be approved for adolescents.Areas covered in this review: This review will provide an overview of migraine in adolescents focusing on epidemiology, pathophysiology, classification and a review of treatment options with attention on the evidence from the past 5 years surrounding almotriptan.What the reader will gain: Given its recent FDA approval, it is important to for clinicians and pharmacists to become familiar with the clinical spectrum of migraine in teenagers and with recent evidence on this newly approved agent, almotriptan.Take home message: Almotriptan is a safe, effective, and approved agent for the acute treatment of migraine headache in adolescents.

Management considerations in the treatment of migraine in adolescents

Migraine is common in adolescents. It can significantly reduce quality of life, may contribute to significant school absences, and disrupt social activities. This article will address the clinical presentation, natural history, types, evaluation, diagnosis and prognosis of migraine. Common adolescent lifestyle factors such as stress, irregular mealtimes, and sleep deprivation may exacerbate migraines. Management options are discussed including lifestyle modifications, acute and preventative therapies. Features of chronic daily headache including comorbid conditions, management, and outcome are also addressed.

Long‐Term, Open‐Label Safety Study of Oral Almotriptan 12.5 mg for the Acute Treatment of Migraine in Adolescents

This study evaluated the long-term safety of oral almotriptan 12.5 mg for the treatment of multiple migraine episodes in adolescents over a 12-month period. Efficacy outcomes were assessed as a secondary objective. Adolescent migraineurs aged 12-17 years were enrolled in this 12-month, open-label study (Study ID CR002827). Patients were instructed to record their assessments on paper headache records whenever they experienced a migraine headache that they treated with study medication. Safety was assessed descriptively and assessments included adverse event (AE) recording, change in laboratory values, vital signs, and electrocardiogram parameters. Efficacy outcomes were assessed descriptively and outcomes included rates for 2- and 24-hour pain relief and sustained pain relief, 2- and 24-hour pain-free and sustained pain-free, and presence of migraine-associated symptoms of photophobia, phonophobia, nausea and vomiting. Overall, 67.1% of patients reported >or=1 AE over the course of the trial, 7.6% had an AE judged by the study investigator to be related to treatment with almotriptan, 2.4% discontinued because of an AE, and 1.9% reported serious AEs. The most commonly reported treatment-related AEs (occurring in >or=1% of patients) were nausea (1.4%) and somnolence (1.4%). Pain relief responses for treated migraines of moderate or severe intensity at baseline were 61.7% and 68.6%, at 2 and 24 hours, respectively; the sustained pain relief rate was 55.5%. Pain-free responses were reported for 40.5% of all treated migraines at 2 hours and 65.9% of treated migraines at 24 hours; the sustained pain-free rate was 38.4%. The proportion of migraines that achieved the pain relief, sustained pain relief, pain-free and sustained pain-free endpoints were similar in the 12- to 14-year and 15- to 17-year age groups. Treating with almotriptan 12.5 mg when headache pain was mild was associated with higher rates of pain relief and pain-free at 2 and 24 hours, and sustained pain relief and sustained pain-free, compared with treatment initiated when pain was severe. Almotriptan 12.5 mg was well tolerated in this adolescent population over a 12-month period. No unexpected safety or tolerability concerns were revealed over the course of this study. The results are consistent with almotriptan 12.5 mg being effective for the acute treatment of pain and symptoms associated with migraine in both younger and older adolescents.

Eletriptan for the Acute Treatment of Migraine in Adolescents: Results of a Double‐Blind, Placebo‐Controlled Trial

Eletriptan is a potent 5-HT(1B/1D) agonist with proven efficacy in the acute treatment of migraine in adults. To evaluate the efficacy and tolerability of eletriptan 40 mg versus placebo in adolescent patients (aged 12-17). A multicenter, double-blind, parallel-group, placebo-controlled trial was conducted comparing 40 mg of oral eletriptan with placebo for the treatment of migraine in adolescent patients. The primary efficacy endpoint was 2-hour headache response, and a number of secondary endpoints were also evaluated. An exploratory analysis evaluated which clinical and demographic characteristics might be correlated with high placebo response. Of 274 patients who treated a migraine attack, 267 were evaluated for efficacy (n = 138 eletriptan; n = 129 placebo) at 2 hours post-dose. There was no significant difference in 2-hour headache response for eletriptan 40 mg versus placebo (57% vs 57%), and no significant improvements were observed for any of the outcomes at 1 or 2 hours post-dose. By contrast, there was a significant advantage for eletriptan 40 mg in reducing headache recurrence within 24 hours post-dose (11% vs 25%, P= .028), and post hoc analyses showed statistically significant differences for sustained headache response rates (52% vs 39%; P= .04) and sustained pain-free response rates (22% vs 10%; P= .013). The strongest clinical predictor of placebo response was triptan-naïve status (i.e., no previous use of any triptan). Eletriptan 40 mg was well tolerated in this population, and the profile of adverse events was similar to that observed in Phase III trials in adult patients. The high placebo response rates reported here for 1- and 2-hour outcomes are in accordance with other studies of triptans in adolescent patients. The evaluation of treatment effect in adolescent migraine might benefit from use of more stringent outcome measures, such as headache recurrence, sustained headache response, and sustained pain-free response at 24 hours post-dose.

1529 Efficacy and safety of oral eletriptan for the treatment of acute migraine in adolescents

1529 Efficacy and safety of oral eletriptan for the treatment of acute migraine in adolescents

Treatment of Migraine in Adolescents: A Review of Efficacy Data with Sumatriptan Nasal Spray

Treatment of Migraine in Adolescents: A Review of Efficacy Data with Sumatriptan Nasal Spray

Rizatriptan 5 mg for the Acute Treatment of Migraine in Adolescents: A Randomized, Double‐Blind, Placebo‐Controlled Study

To investigate the tolerability and efficacy of rizatriptan 5 mg in adolescent migraineurs. Randomized, double-blind, placebo-controlled study. Patients aged 12 to 17 years received rizatriptan 5 mg (n = 149) or placebo (n = 147) for a moderate or severe headache and for up to two recurrences. Headache severity, presence or absence of associated symptoms, and functional disability were assessed over a 4-hour postdose period, and any adverse events were recorded. The primary efficacy measure was pain-free status at 2 hours postdose. Rizatriptan 5 mg was well tolerated. The most commonly reported adverse events (all with incidence of 5% or less) among patients receiving rizatriptan were dry mouth, dizziness, asthenia/fatigue, nausea, and somnolence. The percentage of patients pain-free at 2 hours was 32% for rizatriptan 5 mg versus 28% for placebo (P=.474). The percentage of patients with pain relief (reduction of predose pain intensity to mild or none) at 2 hours was 66% for rizatriptan versus 56% for placebo (P=.079). Placebo response rates were higher than those typically observed in previous studies of rizatriptan in adults. Compared with placebo, rizatriptan significantly improved functional disability at 1.5 and 2 hours, and nausea at 1 and 1.5 hours. Post hoc analysis showed a significant benefit of rizatriptan versus placebo in the percentage of patients who had pain relief when their migraine attacks were treated on weekends (65% versus 36%, P=.046) compared with weekdays (66% versus 61%, P=.365), and the weekend placebo response rate was similar to that seen in adults. Rizatriptan 5 mg was well tolerated and effective on some measures when used in adolescents for the treatment of a migraine attack.