Acute Migraine Attacks Research Articles

Nystagmus and Vertigo in Acute Vestibular Migraine Attacks: Response to Non-Invasive Vagus Nerve Stimulation.

Vestibular migraine (VM) is the most common neurologic cause of vertigo in adults, but there are no currently-approved rescue therapies. This study describes the benefits of non-invasive vagus nerve stimulation (nVNS) on vertigo, headache, and nystagmus during VM attacks. Case series of four VM patients who were evaluated during acute VM episodes in a tertiary referral neurology clinic between February 2019 and January 2020. They underwent bedside neuro-otologic examination, and graded the severity of vertigo and headache using a 10-point visual-analog scale (VAS; 0-no symptoms, 10-worst ever symptoms), before and 15 minutes after nVNS. Average vertigo severity was 5 (median 4.5) before, and 1.5 (median 0.5) after nVNS. Mean headache severity (three patients) before treatment was 4 (median 4), and 0.7 (median 0) after. Spontaneous right-beating nystagmus (Patient 1) nystagmus, upbeat nystagmus (Patient 2), and positional nystagmus (Patient 3) resolved with nVNS. Baseline left-beating nystagmus in Patient 4 from previous vestibular neuritis damped during acute VM but returned to baseline following nVNS. In all four patients, ictal nystagmus resolved, and examination findings returned to baseline. This study suggests nVNS may ameliorate vertigo and headache, as well as nystagmus associated with VM attacks. Larger, sham device-controlled studies are needed to elucidate the benefits of nVNS in VM.

Music Medicine as a Component of Acute Migraine Attack Management in The Emergency Room: A Randomized Controlled Open-Label Trial

Background: Acute severe migraine requiring Emergency Room (ER) visit is managed by giving analgesics for pain relief. Since music medicine has been beneficial in other pain syndromes, the study of its effect as a noninvasive add-on to current management is worth pursuing. Objective: To identify if music medicine in addition to medical therapy will reduce the severity and duration of an acute attack of moderate to severe migraine compared to medical management alone. Methods: An open label randomized controlled trial was conducted at the ER of a tertiary hospital in the Philippines from July 2017 to June 2018. Patients who presented at the ER with acute moderate to severe headache fulfilling the ICH-3 criteria for migraine were included. They were randomized to medical therapy or to medical therapy with music medicine. A decrease in the severity of the headache after one hour of medical treatment was the primary outcome. Results: One hundred eighty-three adult migraneurs were included without difference between group in age, gender, and occupation. There was a statistically significant reduction (p=0.037) in pain severity after one hour in 82 of 87 patients given medical treatment with music medicine (94%) compared to 73 of 86 in the medical therapy alone (85%). There were more headache-free patients at one hour in the music group (55% versus 42%, p=0.05). Conclusion: There is decreased duration and severity of pain when music medicine is added to conventional medical therapy in treating patients with an acute migraine. This is the first randomized trial done in the acute ER setting.

Short-term Efficacy and Safety of Topical β-Blockers (Timolol Maleate Ophthalmic Solution, 0.5%) in Acute Migraine

Oral β-blockers used for the prevention of migraine headache are not effective for the treatment of acute pain. Small case series have suggested that topically applied β-blockers may be useful in the management of acute migraine pain, warranting evaluation with randomized clinical trials. To evaluate the short-term efficacy and safety of topically applied timolol maleate ophthalmic solution, 0.5%, compared with topically applied placebo eyedrops in the treatment of acute migraine attacks. In this randomized, masked placebo-controlled crossover trial conducted from May 27, 2015, to August 28, 2017, 50 patients with migraine were randomized to receive either timolol eyedrops, 0.5%, or a placebo eyedrop (carboxymethyl cellulose, 0.5%). After a 3-month treatment period, patients completed a 1-month washout period and were crossed over to receive the opposite treatment for a final 3 months. Analysis was performed on a modified intent-to-treat basis. After random assignment, patients were instructed to use 1 drop of the assigned medication in each eye at the earliest onset of migraine. The main outcome measure was reduction in pain score with treatment. The primary end point was reduction of pain score by 4 points, or to zero, 20 minutes after instillation of the eyedrop. Of the 50 patients, 42 (84%) were females and the mean (SD) age was 27.3 (11.3) years. Of a total of 619 migraine attacks, 284 (46%) were treated with timolol, 271 (44%) were treated with the placebo, and 64 (10%) occurred during the washout period when no study medications were used. Seven patients (14%) withdrew after randomization. A total of 233 of the timolol-treated migraine attacks (82%) were associated with a reduction in pain score by 4 points, or to zero, at 20 minutes compared with 38 of the placebo-treated attacks (14%), with a difference of 68 percentage points (95% CI, 62-74 percentage points). A generalized estimating equation analysis revealed that pain score reduction at 20 minutes was greater in the timolol group compared with the placebo group by a mean (SE) of 4.63 points (0.34) (P < .001). This randomized crossover trial supports consideration of timolol eyedrops in the acute treatment of migraine. Further research is warranted to determine if the improvements observed are sustained for a longer follow-up and with larger groups. CTRI/2015/05/005829, UTN: U1111-1167-6439.

CGRP: from history to clinical application - A review

The role of calcitonin gene-related peptide (CGRP) and its receptor have played an important role in migraine for the last decades due to development of therapies that target their receptors at the trigeminal pain system, aiming at prevention or relief of acute migraine attacks. At first, CGRP receptor antagonists, called gepants have demonstrated appropriate effectiveness. In addition, they did not cause vasoconstriction, one of the drawbacks of triptans. However, their use had to be discontinued due to the risk of liver toxicity. Humanized monoclonal antibodies towards CGRP and the CGRP receptor have been developed as an alternative approach to block CGRP transmission. Still, there are some questions not fully answered as where CGRP and its receptor are located, how they influence the mechanisms of migraine attacks and if the blood brain barrier has any sort of importance. There is still much to learn about CGRP and migraine pathophysiology, especially its anatomical target sites and anti-CGRP agents. This paper presents a review of CGRP, including a brief history, focusing in CGRP mechanism, updates and future treatments.

Onset of action in placebo-controlled migraine attacks trials: A literature review and recommendation.

Migraine patients want acute treatment to provide complete relief of the migraine attack within 30 minutes. Traditionally, "speed of onset of effect" is evaluated by estimating the time-point for first statistical separation of drug and placebo. The estimated onset of effect can be a few percent difference of patients being pain free in very large randomised, controlled trials. This difference, however, can be clinically irrelevant. Placebo-controlled randomised, controlled trials with pain freedom results from 30 min to 2-4 hours were retrieved from the literature. For each time-point, the therapeutic gain (drug minus placebo) (TG) was calculated. Therapeutic gain for being pain free of 5% was chosen for the definition of "onset of action", since this is approximately 1/3 of the 16% TG and 1/4 of 21% of TG for sumatriptan 50 mg and 100 mg, respectively. A total of 22 time-effect curves based on randomised, controlled trials were analysed. Based on the "onset of action" of 5% pain freedom, the evaluated drugs and administration forms can be classified as follows: i) Early time to onset, ≤30 min (three randomised, controlled trials); ii) medium time to onset, 60 min (nine randomised, controlled trials); iii) delayed time to onset, 90-120 min (10 randomised, controlled trials). Only three non-oral administration forms with a triptan (subcutaneous sumatriptan and nasal zolmitriptan) resulted in an "onset of action" at ≥30 min; in the future, early onset of action should be a priority in the development of new drugs or new administration-forms for the treatment of acute migraine attacks.

Intravenous sodium valproate for acute migraine in the emergency department: A meta‐analysis

The role of intravenous sodium valproate (iVPA) in acute migraine attack has not been completely established. The aim of this updated review was to evaluate the efficacy and safety of iVPA in patients with acute migraine in the emergency department. We searched the PubMed, Web of Science, and Cochrane Library databases for relevant randomized controlled trials (RCTs). The primary outcome was improvement of headache intensity and headache relief. The need for rescue therapy, recurrence of headache, and number of adverse events was also assessed. Seven double-blinded RCTs involving 682 patients were analyzed. Overall, patients receiving iVPA had less improvement of headache intensity (SMD: -0.39, 95% CI: -0.73 to -0.06, P=.02) and lower rate of headache relief (OR: 0.51, 95% CI: 0.33 to 0.77, P=.002) than those receiving other active comparators. In addition, iVPA increased the odds of rescue therapy compared with other active drugs (OR: 3.76; 95% CI: 1.96 to 7.20, P<.0001). Subgroup analysis showed that iVPA was comparable to dexamethasone, with similar improvement of headache intensity, and recurrence of headache. For migraine without aura, we found no significant difference in headache intensity improvement when iVPA was compared with active comparators (SMD: -0.00, 95% CI: -0.54 to 0.54, P=1.00). iVPA was inferior to the studied comparators and was comparable to dexamethasone for aborting migraine attack. Based on the available evidence, iVPA may be a reasonable alternative or salvage therapy. In particular, iVPA might be a promising agent for migraine with aura and migraine status.

Magnesium and Pain.

In terms of antinociceptive action, the main mode of action of magnesium involves its antagonist action at the N-methyl-d-aspartate (NMDA) receptor, which prevents central sensitization and attenuates preexisting pain hypersensitivity. Given the pivotal function of NMDA receptors in pain transduction, magnesium has been investigated in a variety of pain conditions. The oral and parenteral administration of magnesium via the intravenous, intrathecal, or epidural route may alleviate pain and perioperative anesthetic and analgesic requirements. These beneficial effects of magnesium therapy have also been reported in patients with neuropathic pain, such as malignancy-related neurologic symptoms, diabetic neuropathy, postherpetic neuralgia, and chemotherapy-induced peripheral neuropathy. In addition, magnesium treatment is reportedly able to alleviate fibromyalgia, dysmenorrhea, headaches, and acute migraine attacks. Although magnesium plays an evolving role in pain management, better understanding of the mechanism underlying its antinociceptive action and additional clinical studies is required to clarify its role as an adjuvant analgesic.

Pain freedom after 2 hours should be the primary outcome in controlled trials treating migraine attacks.

Pain freedom after 2 hours is the recommended primary endpoint by the International Headache Society in randomized trials investigating drug treatment of acute migraine attacks. In order to demonstrate an early effect of a drug, some drug companies, however, have promoted headache relief (improvement from severe or moderate pain to mild or no pain) at earlier time points than 2 hours as outcome parameter. We analyzed the relationship between pain freedom and headache relief in acute migraine trials and observed that persistent mild headache constituted 90% of headache relief after 0.5 hour and 40% of headache relief after 2 hours. Headache relief at 2 hours should in our view only be used as an outcome measure for comparison with historic data. Prior to 2 hours, headache relief varies with time from intake and the therapeutic gain is very small. Therefore, pain freedom should be used at these early time points.

Acute Migraine: Can the New Drugs Clinically Outpace?

The objective of this article is to discuss and compare the latest approved drugs (lasmiditan, ubrogepant, and rimegepant) for the management of acute migraine in a clinically relevant manner, emphasizing on their efficacy, safety, as well as cost benefits. A PubMed, clincialtrials.gov , and USFDA literature search (2013–2019) was conducted using the following keywords: Lasmiditan; Ubrogepant; Rimegepant; Acute Migraine; 5HT1F; CGRP. We included only English language articles which discussed the efficacy, safety, and tolerability of newly approved drugs for acute migraine. Triptans and NSAIDs have constitutively been the go-to drugs for the management of acute attack of migraine. These three latest drugs (lasmiditan, ubrogepant, and rimegepant) approved by USFDA may prove to be a game-changer, especially for those migraineurs who have accompanying cardiovascular diseases or have been dissatisfied with the existing therapeutic options. Migraine is a chronic debilitating disease for which the therapeutic options are already available, but for a proportion of patients, these options get either contraindicated, or prove to be clinically ineffective, or crop-out as ill-suited due to the adverse effects. In such conditions, the recently approved three drugs by USFDA stand a chance to fulfill the unmet needs. But due to the paucity of head-on trials between different groups of drugs, it is still difficult to comment about which group may clinically outpace by providing better therapeutic gain.

Are Retinal and Peripapillary Blood Flows Affected during Migraine Attack?

ABSTRACT Migraine pathophysiology is complex and partially includes the vasculature. This study compared retinal and peripapillary blood flow parameters in migraine patients during an attack with healthy controls using optical coherence tomography angiography (OCTA). A prospective clinical study was conducted including 52 eyes from 26 migraineurs and 48 eyes from 24 healthy controls. OCTAs were performed with RTVue XR Avanti using AngioVue software. OCTA imaging was performed during the attack period in migraineurs before any treatment for the attack. Vascular densities in the whole image, fovea, superior hemisphere, inferior hemisphere, and temporal, superior, nasal, and inferior regions of the parafoveal area and in the superficial and deep capillary plexuses were acquired and statistically analysed. The flow density parameters were measured in the superficial retinal capillary plexus, deep retinal capillary plexus, outer retinal capillary plexus, and choriocapillaris layers of the macula in a 3-mm diameter area. The peripapillary flow densities were measured for the optic nerve head, vitreous, radial peripapillary capillaries, and choroid in a 4.50-mm diameter area around the optic disc. Vascular density measurements in the superficial plexus were similar between migraineurs and controls (p > .05). Vascular densities in the deep capillary plexus were similar between groups (p > .05), except in the deep superior area (p = .05). Flow areas in the nerve head, vitreous, peripapillary capillary, and choroid segments were similar between migraineurs and controls (p > .05). Macular thickness parameters were also similar between groups (p > .05). The results suggest that an acute migraine attack does not affect retinal or peripapillary blood flow.

Paracetamol versus Ibuprofen for the Acute Treatment of Migraine Headache in Children: A Blinded Randomized Controlled Trial.

To compare the efficacy of oral paracetamol and oral ibuprofen for the management of acute headache in children with migraine without aura. This randomized-controlled trial was done at the Pediatric department of a public hospital in India between 20 May, 2017 and 22 March, 2018, and enrolled children (aged 6-12 y) with Migraine without aura as per International Classification for Headache Disorders, 3rd edition (ICHD-3) criteria. The 50 patients (21 females, mean age 9.9 y) consecutively enrolled were randomized by block randomization to two study groups, with one group (n =25) receiving oral paracetamol (15mg/kg/dose) and the other group (n = 25) oral ibuprofen (10mg/kg/dose), at home, during a single episode of acute migraine headache. The study drugs were dispensed in a blinded fashion. Pain-freedom (score of zero in a 0-10 Visual analogue pain scale) and Pain-relief (≥2-point reduction from the baseline) two-hours after the study drug intake were the primary outcomes. Side-effects to the study drugs were actively solicited. Non-parametric tests for paired data were used. The two groups were similar at baseline. Forty-three children (22 paracetamol group and 21 ibuprofen group) completed the study. Both pain-freedom (32% vs. 28%, P = 0.77) and pain-relief (80% vs. 80%, P = 0.86) were not significantly different between the Paracetamol and Ibuprofen groups, respectively. Ten (23.2%) children had a side-effect due to the study drug, with no significant difference between the groups (13.6% vs. 33.3%; P = 0.11). Both paracetamol and ibuprofen are effective and safe for the treatment of acute migraine attacks in children.

Pyridoxine, folate and cobalamin for migraine: A systematic review.

There is a possible relationship between migraine and hypercoagulability inducing factors, such as hyperhomocysteinemia. In this context, homocysteine (Hcy)-lowering vitamins (B6-folate-B12) may prove beneficial in the management-prophylaxis of migraine. We performed a systematic literature search in order to retrieve studies assessing the supplementation of B6, folate and B12 (alone or as adjunctive therapies) to migraine patients, as well as patients suffering from other primary headache disorders. MEDLINE, EMBASE, CENTRAL, Google Scholar, trial registries and OpenGrey were searched. Twelve relevant articles were retrieved. The management of acute migraine attacks with Hcy-lowering vitamins has not provided promising results (one randomized controlled trial-RCT-and one prospective uncontrolled trial). On the contrary, significant benefits were registered for the use of B6 alone, in combination with folate and in combination with folate and B12 in the prophylaxis of migraine with aura (MA) in adults compared to placebo (five RCTs, only one did not obtain significant results). Folate supplementation alone was not more efficacious than placebo (one RCT). Limited data for the prophylaxis of migraine without aura (MO) in children (two prospective uncontrolled trials) and adults (two prospective uncontrolled trials involving both MA and MO participants) impede the extraction of safe conclusions. An overall attractive safety profile was exhibited with gastrointestinal adverse events being the most common. Overall, a potential beneficial effect regarding the administration of B6, folate and/or B12 in the prophylaxis of MA in adults was indicated. Additional high-quality RCTs that will investigate MO in adults as well as MO and MA in children are warranted.

Ubrogepant: a new era in migraine treatment

Migraine is the most common neurological disorder that leads to incapacitating neurological symptoms. Acute attacks of migraine have been dealt with effectively with non-steroidal anti-inflammatory drugs (NSAIDs), ergot derivatives and triptans since long, but their use is limited by various adverse effects. Recent studies have shown that a neuropeptide, calcitonin gene related peptide (CGRP) plays a major role in pathophysiology of migraine by increasing the pain perception, both at the peripheral and central nervous system levels. So, in the last few years, some CGRP antagonists have found their way in the treatment of both episodic and chronic migraine. Ubrogepant is the first oral CGRP antagonist, that was approved by USFDA (United States food and drug administration) in December 2019, for the acute treatment of migraine with or without aura. It is more potent than the earlier CGRP receptor antagonists, has a good oral bioavailability and the risk of hepatotoxicity is also lesser than the previous Gepants.

Intravenous metoclopramide versus dexketoprofen trometamol versus metoclopramide+ dexketoprofen trometamol in acute migraine attack in the emergency department: A randomized double-blind controlled trial

Study objectiveThe objective of this study was to determine the analgesic efficacy and safety of intravenous, single-dose metoclopramide versus dexketoprofen trometamol versus metoclopramide+ dexketoprofen trometamol in patients presenting with acute migraine attack to the emergency department (ED). MethodsThis single-center, randomized, double-blind study was conducted in a tertiary care ED. Eligible patients met the migraine criteria of the International Headache Society were randomized to receive 10 mg intravenous metoclopramide, 50 mg intravenous dexketoprofen trometamol, or 50 mg dexketoprofen trometamol +10 mg metoclopramide. Visual analogue scale (VAS) was used for pain measurement at baseline, after 15 and 30 min. The primary outcome measure was the changes in the VAS scores at the 15th and 30th minutes of treatment. The secondary outcome measures were the presence of adverse effects and the requirement of rescue medicine. ResultsPatients (n = 150) were randomized into 3 groups with similar VAS scores at baseline. While there was no significant difference between metoclopramide and dexketoprofen trometamol in reducing pain at the 15th and 30th minute (p = 0.618 and p = 0.862, respectively) and between metoclopramide and metoclopramide + dexketoprofen trometamol at the 15th minute (p = 0.074), metoclopramide + dexketoprofen trometamol was superior to both metoclopramide [mean difference: −13.2 mm (95% CI −23.1 to −3.3)] and dexketoprofen trometamol [mean difference: −11.02 mm (95% CI −20.9 to −1.1)] at the 30th min (p = 0.006 and p = 0.025 respectively). The rescue drug was required by 3 patients (6%) were in metoclopramide group, 4 patients (8%) in dexketoprofen trometamol group and one patient (2%) in the metoclopramide + dexketoprofen trometamol group. No side effects were observed in subjects in three treatment groups. ConclusionNo significant difference in VAS was found between three treatment groups at the 15th minute, but metoclopramide + dexketoprofen trometamol was superior to both metoclopramide and dexketoprofen trometamol at the 30th min.

A Comprehensive Review of Over-the-counter Treatment for Chronic Migraine Headaches.

Migraine headaches are a neurologic disorder characterized by attacks of moderate to severe throbbing headache that are typically unilateral, exacerbated by physical activity, and associated with phonophobia, photophobia, nausea, and vomiting. In the USA, the overall age-adjusted prevalence of migraine in female and male adults is 22.3% and 10.8%, respectively. Migraine is a disabling disease that ranks as the 8th most burdensome disease in the world and the 4th most in women. The overarching hypothesis of migraine pathophysiology describes migraine as a disorder of the pain modulating system, caused by disruptions of the normal neural networks of the head. The activation of these vascular networks results in meningeal vasodilation and inflammation, which is perceived as head pain. The primary goals of acute migraine therapy are to reduce attack duration and severity. Current evidence-based therapies for acute migraine attacks include acetaminophen, four nonsteroidal anti-inflammatory drugs (NSAIDs), seven triptans, NSAID-triptan combinations, dihydroergotamine, non-opioid combination analgesics, and several anti-emetics. Over-the-counter medications are an important component of migraine therapy and are considered a first-line therapy for most migraineurs. These medications, such as acetaminophen, ibuprofen, naproxen, and aspirin, have shown strong efficacy when used as first-line treatments for mild-to-moderate migraine attacks. The lower cost of over-the-counter medications compared with prescription medications also makes them a preferred therapy for some patients. In addition to their efficacy and lower cost, over-the-counter medications generally have fewer and less severe adverse effects, have more favorable routes of administration (oral vs. subcutaneous injection), and reduced abuse potential. The purpose of this review is to provide a comprehensive evidence-based update of over-the-counter pharmacologic options for chronic migraines.

Ubrogepant: The First Gepant to Pass Food and Drug Administration for Acute Migraine

Migraine is one of the most common and disabling forms of primary headache disorders. It is characterized by the presence of unilateral pulsatile headache associated commonly with nausea, vomiting, photophobia, and phonophobia lasting for about 4–72 h. Currently, nonsteroidal anti-inflammatory drugs, ergot alkaloids, and triptans are the most commonly used drugs to abort an acute attack of migraine. Management of acute migraine is becoming a challenging task to physicians and patients due to several drawbacks faced with the use of aforementioned drugs. This lacuna is being filled up by developing drugs against novel targets such as calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase-activating peptide. In December 2019, the US Food and Drug Administration (FDA) approved ubrogepant for the treatment of acute migraine with or without aura in adults. Ubrogepant belongs to a new class of drugs called “Gepants” which are small molecules targeted against the CGRP receptor. The recommended initial dose is 50 mg or 100 mg orally. It follows first-order kinetics and is metabolized to a major extent by CYP3A4-mediated mechanisms. Compared to placebo, ubrogepant causes significant and rapid freedom from headache, pain and absence of migraine-associated most bothersome symptoms. Nausea, vomiting, and dry mouth are some of its common adverse effects. Ubrogepant with advantages such as good oral bioavailability, lack of vasoconstrictor action, and lack of hepatotoxicity might emerge as a promising drug for terminating an acute attack of migraine in the future. However, long-term clinical studies are needed to ascertain its safety profile.

The Effect of Intravenous Fluid Therapy in Acute Migraine Attacks

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Do doctors treat themselves differently than their patients? Study on the self-treatment of migraine among German neurologists and pain specialists.

To investigate whether the self-treatment of migraine among neurologists and pain specialists corresponds to national medical guidelines and treatment of patients. An email cross-sectional survey was sent to members of the German Society for Neurology, German Pain Society and German Migraine and Headache Society containing questions on demographics, professional experience and specialization and - in case participants suffered from migraine - questions about their migraine and its treatment. 175/418 (41.9%) participants suffered from migraine (m: 29.3%; f: 55.2%, 45.9 ± 10.7 years). For acute migraine attacks, 96.6 % of them use a first-line treatment according to the medical guidelines. Seventeen (9.7%) are currently taking a migraine prophylaxis, 52.9% of these use a recommended first-line prophylaxis. In all, 21.7% are not taking a prophylactic treatment despite an indication (based on number of monthly migraine days) for it, due to fear of side-effects, low intensity of migraine attacks and a sufficient effect of acute medication. This group of participants was younger, less experienced and specialized and was mainly employed (vs. self-employed) compared to those taking a prophylaxis. A total of 96.6% reported treating their patients in line with current guidelines; 14.3% would treat themselves differently when they were their own patients. The self-treatment of acute migraine attacks for the most part complies with the guidelines but, regarding the indication for a prophylaxis, a more divergent treatment approach was observed among younger, less experienced physicians. For the majority of physicians there is no difference between self-treatment and treatment of migraine patients.

The Risks or Lack Thereof of Migraine Treatments in Vascular Disease.

Patients with migraine have a co-morbidity with vascular diseases such as hypertension, coronary heart disease, and stroke. This overview gives recommendations for the therapy of acute migraine attacks and for migraine prevention in patients with vascular diseases. In particular, the use of triptans in patients with vascular diseases is discussed. Currently, there is a contraindication for the use of the triptans in patients with vascular disease, although there is no evidence that triptans increase the risk of heart attacks or stroke.

What are the effects of sumatriptan plus naproxen for adults with acute migraine attacks?

What are the effects of sumatriptan plus naproxen for adults with acute migraine attacks?