Prophylactic Treatment Of Migraine Research Articles

Reliability, validity, and responsiveness of the Arabic version of HIT-6 questionnaire in patients with migraine indicated for preventive therapy: A multi-center study.

The Headache Impact Test (HIT-6) is an important patient-reported outcome measure (PROM) in migraine prevention trials. This study aimed to (i) assess the reliability and validity of the Arabic version of HIT-6 in Arabic-speaking patients experiencing migraine, and (ii) evaluate the responsiveness of HIT-6 following migraine preventive therapy. In this prospective study, patients with migraine (n = 145) were requested to fill out a headache diary, the Arabic version of HIT-6, and Migraine Disability Assessment Scale (MIDAS) at two time points (baseline and 3 months after initiation of prophylactic treatment). Some respondents (n = 73) were requested to fill out HIT-6 again 1 week from the baseline for test-retest reliability. The intensity of migraine headache attacks was evaluated using the Visual Analogue Scale (VAS). An anchor-based method was used to establish the minimal important change (MIC) value and responsiveness of HIT-6. The total scores of HIT-6 were significantly correlated to a fair degree with MIDAS (r = 0.41), as well as VAS (r = 0.53), and monthly migraine days (r = 0.38) at the baseline while at the follow-up (after 3 months), the correlations were of moderate degree with MIDAS scores (r = 0.62) and monthly migraine days (r = 0.60; convergent validity). Reliability estimates of the Arabic HIT-6 were excellent (Cronbach's α = 0.91 at baseline and 0.89 at follow-up). The average measure interclass correlation coefficient (ICC) value for the test-retest reliability was 0.96 (95% confidence interval = 0.94-0.98, p < 0.001). The HIT-6 total score is sensitive to change, being significantly reduced after prophylactic treatment compared to before (effect size = 1.5, standardized response mean = 1.3). A reduction from baseline of 4.5 on HIT-6 showed the highest responsiveness to predict improvement with an area under the curve equal to 0.66, sensitivity of 80%, specificity of 45%, and significance at 0.021. Changes in the HIT-6 total score were positively correlated with changes in monthly migraine days (r = 0.40) and VAS scores (r = 0.69) but not with changes in the score of MIDAS (r = 0.07). The Arabic version of HIT-6 is valid, reliable, and sensitive to detect clinical changes following migraine prophylactic treatment with a MIC of 4.5 points.

Napex acupoint thread-embedding combined with metoprolol tartrate tablet for prophylactic treatment of migraine without aura: a randomized controlled trial.

To observe the efficacy of napex acupoint thread-embedding combined with metoprolol tartrate tablet for prophylactic treatment of migraine without aura, and to compare its efficacy with simple napex acupoint thread-embedding and simple metoprolol tartrate tablet. A total of 105 patients with migraine without aura were randomized into a combination group (35 cases, 5 cases dropped out), a thread-embedding group (35 cases, 4 cases dropped out) and a western medication group (35 cases, 2 cases dropped out). In the thread-embedding group, napex acupoint thread-embedding was applied at bilateral Fengchi (GB 20) and points of 1.5 cun nearby to the lower edge of spinous process of cervical 2. In the western medication group, metoprolol tartrate tablet was given orally, 12.5 mg a time, twice a day. In the combination group, napex acupoint thread-embedding combined with oral metoprolol tartrate tablet was delivered. The treatment of 8 weeks was required in the 3 groups. The days of headache attacks, frequency of headache attacks, headache severity (visual analogue scale [VAS] score) and the migraine specific quality of life questionnaire version 2.1 (MSQ) score were observed during baseline period (4 weeks before treatment to before treatment), observation period (1-4 weeks and 5-8 weeks in treatment) and follow-up period (1-4 weeks after treatment completion) respectively, the proportions of the days of headache attacks/frequency of headache attacks relieved by 50% were calculated, and the safety was evaluated in the 3 groups. During the observation period and the follow-up period, the days of headache attacks, frequency of headache attacks and headache VAS scores in the 3 groups were reduced compared with those of the baseline period (P<0.05). During the observation period and the follow-up period, the days of headache attacks and the frequency of headache attacks in the combination group were lower than those in the thread-embedding group and the western medication group (P<0.05); during the observation period (1-4 weeks in treatment), the headache VAS scores in the combination group and the thread-embedding group were lower than that in the western medication group (P<0.05); during the observation period (5-8 weeks in treatment) and the follow-up period, the headache VAS scores in the combination group were lower than those in the thread-embedding group and the western medication group (P<0.05). During the observation period and the follow-up period, the scores of role restriction, role prevention and emotion function of MSQ in the combination group were increased compared with those of the baseline period (P<0.05); during the observation period (5-8 weeks in treatment) and the follow-up period, the role prevention scores of MSQ in the thread-embedding group and the western medication group were increased compared with those of the baseline period (P<0.05); during the follow-up period, the emotion function scores of MSQ in the thread-embedding group and the western medication group were increased compared with those of the baseline period (P<0.05). During the observation period and the follow-up period, the scores of role restriction, role prevention and emotion function of MSQ in the combination group were higher than those in the thread-embedding group and the western medication group (P<0.05). There was no statistical difference in the proportions of the days of headache attacks/frequency of headache attacks relieved by 50% among the 3 groups (P>0.05), and there were no serious adverse reactions in the 3 groups. Napex acupoint thread-embedding combined with metoprolol tartrate tablet, simple napex acupoint thread-embedding and simple metoprolol tartrate tablet all can reduce the days of headache attacks and the frequency of headache attacks, relieve headache severity and improve the quality of life in patients with migraine without aura. Napex acupoint thread-embedding combined with metoprolol tartrate tablet has a better effect.

Anti-CGRP-based Migraine Medications: A Comprehensive Overview

In the early 1990s, the neuropeptide calcitonin gene-related peptide (CGRP) was identified as a key messenger in the pathophysiology of migraine and emerged as a treatment target, fundamentally transforming our approach to migraine therapy. While previous prophylactic drugs were non-specific and often caused intolerable side effects, the discovery of CGRP marked the advent of a new era in migraine treatment. The two main classes of CGRP-specific migraine treatments are monoclonal antibodies that bind to CGRP or the CGRP receptor, and CGRP receptor antagonists, the so-called gepants. Extensive clinical trials have conclusively demonstrated the safety, tolerability, and efficacy of monoclonal CGRP(-receptor) antibodies in the prophylactic treatment of both episodic and chronic migraine. The same positive results apply to the use of various gepants. They have proven to be not only an effective alternative to triptans in acute migraine therapy but also promising options for continuous use as prophylactic treatments. In this review, we aim to present the current state of research on CGRP-specific migraine therapy and insights in real-world data from the first years after their launch in clinical practice.

Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis

BackgroundThe reimbursement of erenumab in Spain and other European countries is currently restricted because of the cost of this novel therapy to patients with migraine who have experienced previous failures to traditional preventive treatments. However, this reimbursement policy should be preferably based on cost-effectiveness studies, among other criteria. This study performed a cost-effectiveness analysis of erenumab versus topiramate for the prophylactic treatment of episodic migraine (EM) and versus placebo for chronic migraine (CM).MethodsA Markov model with a 10-year time horizon, from the perspective of the Spanish National Healthcare System, was constructed based on data from responder and non-responder patients. A responder was defined as having a minimum 50% reduction in the number of monthly migraine days (MMD). A hypothetical cohort of patients with EM with one or more prior preventive treatment failures and patients with CM with more than two treatment failures was considered. The effectiveness score was measured as an incremental cost per quality-adjusted life year (QALY) gained and cost per migraine day (MD) avoided. Data from clinical outcomes and patient characteristics were obtained from erenumab clinical trials (NCT02066415, STRIVE, ARISE, LIBERTY and HER-MES). Deterministic and probabilistic sensitivity analyses were performed to validate the robustness of the model.ResultsAfter a 10-year follow-up, the estimated QALYs were 5.88 and 6.11 for patients with EM treated with topiramate and erenumab, respectively. Erenumab showed an incremental cost per patient of €4,420 vs topiramate. For CM patients, erenumab resulted in 0.756 QALYs gained vs placebo; and an incremental cost of €1,814. Patients treated with erenumab achieved reductions in MD for both EM and CM (172 and 568 MDs, respectively). The incremental cost per QALY gained with erenumab was below the Spanish threshold of €30,000/QALY for both health and societal perspectives (EM €19,122/QALY and CM €2,398/QALY).ConclusionsErenumab is cost-effective versus topiramate as a preventive treatment for EM and versus placebo for patients with CM from the perspective of the Spanish National Health System.

Eptinezumab for the preventive treatment of episodic and chronic migraine: a narrative review.

Eptinezumab, a monoclonal antibody that targets calcitonin gene-related peptide (CGRP), was recently approved in Europe for the prophylactic treatment of migraine in adults who have at least four migraine days a month. Eptinezumab is administered by intravenous infusion every 12 weeks. During recent months, a considerable amount of evidence from eptinezumab trials has been published. The aim of this review is to describe the existing evidence on the tolerability, safety and efficacy of eptinezumab in patients with migraine. Data from randomized (PROMISE-1, PROMISE-2, RELIEF and DELIVER) and open-label (PREVAIL) phase 3 clinical trials have demonstrated the favorable effect of eptinezumab in migraine symptoms from first day of treatment. These studies showed that eptinezumab results in an overall reduction in mean monthly migraine days (MMDs), increases in the ≥50% and ≥ 75% migraine responder rates (MRRs) and improvements in patient-reported outcome measures in both patients with episodic migraine (EM) and with chronic migraine (CM), including patients who failed previous preventive treatments. The RELIEF trial also showed that eptinezumab, within 2 h of administration, reduced headache pain, migraine-associated symptoms and acute medication use when administered during a migraine attack. Eptinezumab benefits manifested as early as day 1 after dosing and with the subsequent doses lasted up to at least 2 years. Treatment-emergent adverse events reported by ≥2% of patients included upper respiratory tract infection and fatigue. Current evidence demonstrates that eptinezumab has a potent, fast-acting, sustained migraine preventive effect in patients with EM and CM. Eptinezumab has also shown to be well tolerated, supporting its use in the treatment of patients with migraine and inclusion in the current migraine therapeutic options.

Indian Consensus on the Role of Amitriptyline in Migraine Prophylaxis.

Migraine is a globally prevalent neurological disorder. Amitriptyline, a tricyclic antidepressant, has shown potential as a prophylactic treatment for migraine; however, its role as a first-line medication has been debated. A modified Delphi method was used to develop consensus statements on migraine and its management. The literature review identified knowledge gaps, and two survey rounds were conducted among a panel of experts. Consensus was reached for 12 out of 23 initial survey questions, whereas no consensus was reached for four questions after the deliberation in the second round. The results showed that migraine is highly prevalent among women aged 15-35 years in India. Amitriptyline is an effective monotherapy for prophylactic migraine management, with a recommended initial dose of 5-10 mg. A gradual titration over six months achieves optimal results. Amitriptyline is also safe for managing catamenial migraine and can be used at lower doses during pregnancy to alleviate symptoms. The outcomes of this study emphasize that amitriptyline should be considered as a primary prophylactic treatment for migraine because of its efficacy and safety. The evidence-based consensus achieved is intended to serve as guidance for healthcare practitioners in India, and it is anticipated that such adoption will lead to improvement in patient outcomes and an enhancement in the quality of life for those affected by migraines.

Prophylactic treatment of migraine: Experience in Neurological Center of Cartagena De Indias, Colombia. Preliminary results

Prophylactic treatment of migraine: Experience in Neurological Center of Cartagena De Indias, Colombia. Preliminary results

Comparison between the effectiveness of three prophylactic drugs for vestibular migraine; cinnarizine, propranolol, and topiramate: prospective study

BackgroundVestibular migraine (VM) is considered one of the most common causes of episodic vertigo. Acute attacks may interfere or hinder daily activities, and hence decrease the quality of life. Accordingly, this study was designed to evaluate and compare the effectiveness of Cinnarizine, Propranolol, and Topiramate as prophylactic treatment for vestibular migraine, in order to decrease the occurrence of acute attacks. Several medications have been proposed as a prophylactic treatment, but their benefit is still a vast field of study.MethodsForty-five subjects were diagnosed with vestibular migraine. They were divided into 3 groups; each group either received Cinnarzine, Propranolol, or Topiramate. All patients were submitted to thorough history taking for headache and vertiginous attacks, Dizziness Handicap Inventory questionnaire (DHI) -Arabic version, visual analog scale, videonystagmography, and computerized dynamic posturography (CDP) before and after receiving the treatment by 3 months.ResultsTopiramate was significantly superior in reducing the frequency and severity of headache attacks. The three drugs showed improvement but with no significant difference as regards duration and frequency of vertiginous attacks, DHI scores, and CDP. Only 5 patients had non-serious temporary side effects.ConclusionsThe three drugs were effective for ameliorating vertiginous attacks in vestibular migraine patients, but Topiramate was better in the 25 mg twice daily dose.

Tai Chi for the prophylaxis of episodic migraine: protocol of a non-inferiority randomized controlled trial with mechanism exploration

BackgroundMigraine is a complex neurovascular disorder with considerable clinical, social and economic issues. Tai chi has the potential to be an alternative prophylactic treatment for migraine with high safety since the adverse effects and limited efficacy of available medications.AimsThe proposed study aims to compare the prophylaxis efficacy of 24-week Tai Chi training on migraine attacks with the standard prophylactic medication; and to explore the mechanism of Tai Chi in preventing migraine attacks by analyzing the associations between changes of migraine attacks and changes of neurovascular functions and inflammatory makers.MethodThis is a two-arm parallel non-inferiority randomized controlled trial. In total 220 Hong Kong Chinese women aged 18–65 years with diagnosis of episodic migraine will be recruited and randomized to either the Tai Chi training group or the standard prophylactic medication group with 1:1 ratio, and receive the 24 weeks of modified 33-short form Yang-style Tai Chi training and the standard prophylactic medications, respectively. A 24-week follow-up will be implemented for both groups. For efficacy examination, the primary outcome was the frequency of migraine attacks measured by the migraine diary; and for the mechanism exploration, the primary outcome was the volume and number of white matter hyperintensity (WMH) measured by magnetic resonance imaging (MRI). The measurements will be conducted at the baseline, 24th weeks, and 48th weeks. Linear mixed model will be adopted to comprehensively analyze the changes of variables within and between groups.DiscussionGiven the importance of reducing disease burden and financial cost of migraine attacks, the findings of this study will provide new insights regarding the role of Tai Chi in alleviating migraine burden and further shed light on the mechanism action of Tai Chi on preventing headache attacks.Trial registrationClinicalTrials.gov NCT05690737. Registered on January 28, 2023.

Predictors of galcanezumab response in a real-world study of Korean patients with migraine

To assess factors associated with galcanezumab response in a real-world study of Korean patients with migraine. Predictors of the efficacy of monoclonal antibodies targeting calcitonin gene-related peptide (CGRP) or its receptor (anti-CGRP(-R) mAb) have been rarely investigated in Asians. We prospectively recruited and followed up patients with migraine who received monthly galcanezumab treatment in a single university hospital from June 2020 to October 2021. We defined the treatment response with ≥ 50% reduction in moderate/severe headache days in the 3rd month of treatment compared to baseline. Responders and non-responders were compared in terms of demographics, disease characteristics and severity, and previous response to migraine prophylactic treatments. Potential predictors of anti-CGRP(-R) mAb response were tested by using the univariable and multivariable logistic regression analyses. Among 104 patients (81.7% female; mean age 42.0 ± 13.02; 76.9% chronic migraine; and 45.5% medication overuse headache) included, 58 (55.7%) were responders. Non-responders had more chronic migraine, medication overuse headache, monthly headache days, days with acute medication, and daily headaches (i.e. chronic migraine persisting everyday without remission). The multivariable logistic analysis showed chronic migraine (OR 0.05 [95% CI 0.00–0.82], p = 0.036) and the number of previously failed preventive medication classes (OR 0.55 [95% CI 0.33–0.92], p = 0.024] were independently associated with treatment response. Chronic migraine and multiple failures from preventive medication are associated with poor galcanezumab response. Further studies are needed to investigate if earlier treatment before disease chronification or multiple failures may lead to a greater therapeutic gain from anti-CGRP(-R) mAb treatment.

The Effect of Coenzyme Q10 as a Prophylactic Treatment in Episodic Migraine

Aim: Migraine is a neurological disorder characterized by recurring and often severe headaches. The aim of this study was to evaluate the effectiveness of coenzyme Q10 (CoQ10) in episodic migraine prophylaxis. Material and Methods: In a prospective follow-up study, 80 patients with episodic migraine were enrolled according to the International Classification of Headache Disorders 3rd edition and divided into two groups. One group consisted of 40 patients who received CoQ10 oral 200 mg twice daily as monotherapy for three months, while the other group consisted of 40 patients who received CoQ10 as an adjunct therapy in combination with other prophylactic antimigraine drugs. The Migraine Disability Assessment (MIDAS) questionnaire was administered to both groups before and after three months of therapy. Throughout the three-month therapy period, patients recorded daily symptoms, allowing for observation of changes in symptom severity, number, and duration of attacks from baseline. Results: Both groups that received CoQ10 supplementation exhibited positive responses. The group receiving adjunct therapy showed a statistically more significant reduction in the MIDAS (p&amp;lt;0.001), duration (p&amp;lt;0.001), and frequency (p&amp;lt;0.001) of attacks compared to the monotherapy group. Vomiting (p&amp;lt;0.001) in the adjunct therapy group completely disappeared and sound sensitivity (p=0.002) showed a dramatic response to treatment. Conclusion: CoQ10 appears to have more beneficial effects as an adjunct than monotherapy in reducing the duration, frequency, and presenting symptoms such as nausea, vomiting, and light sensitivity, in addition to sound sensitivity that responded only to adjunct therapy than monotherapy among Iraqi patients with episodic migraine.

Effectiveness of Acupuncture for Prophylactic Treatment of Migraine: A Systematic Review and Bayesian Network Meta-Analysis.

It is aimed to evaluate the effectiveness and provide evidence-based medical support for acupuncture as a prophylactic treatment for migraines. Randomized controlled trials (RCTs) from inception to April 2022 are included in 14 databases. Pairwise meta-analysis is conducted using STATA software V14.0, while Windows Bayesian Inference Using Gibbs Sampling (WinBUGS V.1.4.3) is applied to generate Bayesian Network Meta-analysis (NMA) using Markov chain Monte Carlo algorithm. Forty RCTs are included, with 4405 participants. The effectiveness of six acupuncture techniques, three types of prophylactic drugs, and psychotherapy are compared and ranked. Acupuncture outperformed prophylactic drugs in terms of diminishing visual analog scale (VAS) score, migraine attack frequency, and days during the treatment and at the 12-week follow-up. At the 12-week follow-up, the effectiveness of various interventions is ranked as follows: manual acupuncture (MA) > electroacupuncture (EA) > calcium antagonists (CA) in reducing VAS score; MA > EA > CA in reducing migraine attack frequency; MA > EA > β-receptor blocker and CA in reducing headache attack days. Acupuncture is a promising treatment for migraine prevention. The best option of acupuncture for improving various migraine outcomes has changed over time. However, the quality of included trials and NMA inconsistency limited the credibility of the conclusion.

Atogepant: the chief oral drug developed specifically for prophylactic treatment of episodic migraine

Atogepant: the chief oral drug developed specifically for prophylactic treatment of episodic migraine

Acute and prophylactic treatment of migraine

Migraine is a chronic neurological disorder that causes significant disability in patients and has a substantial economic impact in Canada. Effective treatment for migraine will improve our patients’ quality of life; additionally, it will reduce the economic burden generated by healthcare visits and employee absenteeism.&#x0D; The novel treatments in migraine target calcitonin gene-related peptide (CGRP), a neuropeptide which plays a role in the initiation of a migraine attack. Although our current understanding of migraine pathophysiology is incomplete, it is believed to involve the trigeminal nerve and its connections with the cerebral vasculature with nociceptive signals activated through a variety of neuropeptides including CGRP, substance P and nitric oxide.&#x0D; As a result of an improved understanding of migraine pathophysiology, the past several years have seen the advent of a variety of new therapeutic options in both the acute and prophylactic management of migraine. Although these agents represent additional options in the clinician’s arsenal, they have, in addition, introduced challenges in determining their cost-effectiveness. In this review, we provide an update on new acute and prophylactic migraine therapies and how they integrate into current practice from a primary care perspective.

Migraine, chronic kidney disease and kidney function: observational and genetic analyses

Epidemiological studies demonstrate an association between migraine and chronic kidney disease (CKD), while the genetic basis underlying the phenotypic association has not been investigated. We aimed to help avoid unnecessary interventions in individuals with migraine through the investigation of phenotypic and genetic relationships underlying migraine, CKD, and kidney function. We first evaluated phenotypic associations using observational data from UK Biobank (N = 255,896). We then investigated genetic relationships leveraging genomic data in European ancestry for migraine (Ncase/Ncontrol = 48,975/540,381), CKD (Ncase/Ncontrol = 41,395/439,303), and two traits of kidney function (estimated glomerular filtration rate [eGFR, N = 567,460] and urinary albumin-to-creatinine ratio [UACR, N = 547,361]). Observational analyses suggested no significant association of migraine with the risk of CKD (HR = 1.13, 95% CI = 0.85–1.50). While we did not find any global genetic correlation in general, we identified four specific genomic regions showing significant for migraine with eGFR. Cross-trait meta-analysis identified one candidate causal variant (rs1047891) underlying migraine, CKD, and kidney function. Transcriptome-wide association study detected 28 shared expression–trait associations between migraine and kidney function. Mendelian randomization analysis suggested no causal effect of migraine on CKD (OR = 1.03, 95% CI = 0.98–1.09; P = 0.28). Despite a putative causal effect of migraine on an increased level of UACR (log-scale-beta = 0.02, 95% CI = 0.01–0.04; P = 1.92 × 10−3), it attenuated to null when accounting for both correlated and uncorrelated pleiotropy. Our work does not find evidence supporting a causal association between migraine and CKD. However, our study highlights significant biological pleiotropy between migraine and kidney function. The value of a migraine prophylactic treatment for reducing future CKD in people with migraine is likely limited.

Ultrasound-guided stellate ganglion block for the treatment of migraine in elderly patients: A retrospective and observational study.

This study aimed to assess the effectiveness and safety of ultrasound-guided stellate ganglion block (SGB) in the prophylactic treatment of migraine in the elderly. Treatment of migraine in the elderly is often difficult and troublesome due to multiple comorbidities, drug interactions, and adverse effects (AEs). SGB may be an effective treatment approach for migraine in the elderly as its clinical use is rarely limited by concomitant diseases and age-related physiological changes; however, no studies have evaluated the effectiveness of SGB in the treatment of migraine in the elderly population. This is a retrospective observational case series study. We retrospectively analyzed patients with migraine aged ≥65 years, who underwent ultrasound-guided SGB for headache management between January 2018 and November 2022. Pain intensity using the numerical rating scale (NRS, 0-10), number of days with headache per month, duration of headache, and the consumptions of acute medications were recorded before SGB treatment, and at 1, 2, and 3 months after the last SGB. Safety assessment included thorough documentation of serious and minor AEs related to SGB. Of 71 patients, 52 were analyzed in this study. After the final SGB, the NRS scores decreased significantly from a mean (± standard deviation [SD]) of 7.3 (1.2) at baseline to 3.3 (1.4), 3.1 (1.6), and 3.6 (1.6) at 1, 2, and 3 months, respectively (vs. baseline, p < 0.001). The mean (SD) number of headache days per month significantly reduced from 23.1 (5.5) to 10.9 (7.1) (p < 0.001), 12.7 (6.5) (p = 0.001), and 14.0 (6.8) days (p = 0.001) at the 1-, 2-, and 3-month follow-ups, respectively. The values of headache duration were also significantly lower at the 1-month (mean [SD] 12.5 [15.8] h, p = 0.001), 2-month (mean [SD] 11.3 [15.9] h, p = 0.001), and 3-month follow-ups (mean [SD] 14.3 [16.0] h, p = 0.001) compared to pre-treatment baseline (mean [SD] 22.7 [17.1] h). There were 33/52 (64%) patients experiencing at least a 50% reduction in acute medications consumption 3 months after the final SGB treatment. The overall AEs rate associated with ultrasound-guided SGB was 9.0% (26/290 SGBs). There were no serious AEs; all reported AEs were minor and transient. Stellate ganglion block treatment could reduce pain intensity, headache frequency, and duration of migraine, thereby reducing the need for adjunctive medications in elderly patients. Ultrasound-guided SGB might be a safe and effective intervention for the treatment of migraine in elderly patients.

Real-world effectiveness of fremanezumab in patients with migraine switching from another mAb targeting the CGRP pathway: a subgroup analysis of the Finesse Study

BackgroundMonoclonal antibodies targeting the CGRP pathway are effective and safe for prophylactic treatment of episodic (EM) and chronic migraine (CM). In case of treatment failure of a CGRP pathway targeting mAb, physician has to decide whether using another anti-CGRP pathway mAb is useful. This interim analysis of Finesse Study evaluates effectiveness of the anti-CGRP mAb fremanezumab in patients with a history of other prior anti-CGRP pathway mAb treatments (switch patients).MethodsFinesse, a non-interventional, prospective, multicentre, two-country (Germany-Austria) study observing migraine patients receiving fremanezumab in clinical routine. This subgroup analysis presents data on documented effectiveness over 3 months after the first dose of fremanezumab in switch patients. Effectiveness was evaluated based on reduction in average number of migraine days per month (MMDs), MIDAS and HIT-6 scores changes as well as in number of monthly days with acute migraine medication use.ResultsOne hundred fifty-three out of 867 patients with a history of anti-CGRP pathway mAb treatment prior to initiation of fremanezumab were analysed. Switch to fremanezumab led to ≥ 50% MMD reduction in 42.8% of migraine patients, with higher response rate in EM (48.0%) than in CM patients (36.5%). A ≥ 30% MMD reduction was achieved by 58.7% in CM patients. After three months, monthly number of migraine days decreased by 6.4 ± 5.87 (baseline: 13.6 ± 6.5; p < 0.0001) in all patients, 5.2 ± 4.04 in EM and 7.7 ± 7.45 in CM patients. MIDAS scores decreased from 73.3 ± 56.8 (baseline) to 50.3 ± 52.9 (after 3 months; p = 0.0014), HIT-6 scores decreased from 65.9 ± 5.0 to 60.9 ± 7.2 (p < 0.0001). Concomitant use of acute migraine medication had decreased from 9.7 ± 4.98 (baseline) to 4.9 ± 3.66 (3 months) (p < 0.0001).ConclusionsOur results show that about 42.8% of anti-CGRP pathway mAb-non-responder benefit from switching to fremanezumab. These results suggest that switching to fremanezumab may be a promising option for patients experiencing poor tolerability or inadequate efficacy with prior other anti-CGRP pathway mAb use.Trial registrationFinesse Study is registered on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (EUPAS44606).Graphical

Rimegepant for migraine: acute efficacy beyond the USA

The safety and efficacy of rimegepant, a synthetic molecule that competes with calcitonin gene-related peptide (CGRP) for binding to its receptor, have been shown in two phase 3 studies on symptomatic treatment 1 Lipton RB Croop R Stock EG et al. Rimegepant, an oral calcitonin gene-related peptide receptor antagonist, for migraine. N Engl J Med. 2019; 381: 142-149 Crossref PubMed Scopus (177) Google Scholar , 2 Croop R Goadsby PJ Stock DA et al. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019; 394: 737-745 Summary Full Text Full Text PDF PubMed Scopus (172) Google Scholar and one on prophylactic treatment 3 Croop R Lipton RB Kudrow D et al. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021; 397: 51-60 Summary Full Text Full Text PDF PubMed Scopus (106) Google Scholar of migraine, all done in the USA. On the basis of these data, rimegepant was the first CGRP antagonist (gepant) to be approved by the US Food and Drug Administration and European Medicines Agency for both symptomatic and prophylactic treatment of migraine, giving it a unique and innovative role in the treatment of headaches. Rimegepant is available as a pill for oral administration as needed by people with migraine (ie, whenever they have a migraine attack 4 Mitsikostas DD Belesioti I Arvaniti C et al. Patients' preferences for headache acute and preventive treatment. J Headache Pain. 2017; 18: 102 Crossref PubMed Scopus (26) Google Scholar ), possibly without the risk of developing medication overuse headache, and without the need to take another medication for migraine prophylaxis. Until the development of the anti-CGRP treatments, all prophylactic anti-migraine medications had been repurposed from other diseases; these older treatments have little evidence of efficacy in migraine prophylaxis and have well known side-effects, which increases the likelihood that individuals have adverse events, reducing adherence and benefit. 5 Charles A Pozo-Rosich P Targeting calcitonin gene-related peptide: a new era in migraine therapy. Lancet. 2019; 394: 1765-1774 Summary Full Text Full Text PDF PubMed Scopus (157) Google Scholar By contrast, CGRP-pathway-targeting drugs are mechanism-based, are migraine-specific, and have very good evidence of tolerability and safety. 6 Hepp Z Dodick DW Varon SF Gillard P Hansen RN Devine EB Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia. 2015; 35: 478-488 Crossref PubMed Scopus (254) Google Scholar Safety and efficacy of rimegepant orally disintegrating tablet for the acute treatment of migraine in China and South Korea: a phase 3, double-blind, randomised, placebo-controlled trialAmong adults living in China or South Korea, a single dose of 75 mg rimegepant was effective for the acute treatment of migraine. Safety and tolerability were similar to placebo. Our findings suggest that rimegepant might be a useful new addition to the range of medications for the acute treatment of migraine in China and South Korea, but further studies are needed to support long-term efficacy and safety and to compare rimegepant with other medications for the acute treatment of migraine in this population. Full-Text PDF

Non-invasive brain stimulation treatments for migraine prophylaxis: a network meta-analysis of randomized controlled trials.

Migraine is a major public health problem owing to its long disease duration and disease relapse. Non-invasive brain stimulation treatments were reported effective for the management of migraine, but the comparative effectiveness of three main NIBSs, rTMS, nVNS, and tDCS, has not been studied. We aimed to explore the relative efficacy of rTMS, tDCS, and nVNS in migraine prophylaxis by using network meta-analysis (NMA). We searched OVID Medline, Embase, Cochrane Controlled Register of Trials, and Web of Science from inception to 1 January 2022. Randomized controlled trials that reported the efficacy of rTMS, tDCS or nVNS in the prophylactic treatment of migraine were included. The primary outcome was monthly migraine frequency, and secondary outcomes were headache intensity and the impact of headaches on daily life. The relative effects of the treatments in contrast to the others were measured by using standard mean difference (SMD). We included 31 trials with 1659 participants. Fourteen trials were rated as low risk of bias. The results showed that tDCS (SMD - 1.58; 95%CI, - 2.38 to - 0.79; P-score = 0.92) had the largest effect on migraine frequency when compared with sham interventions in reducing monthly migraine frequency, and tDCS had a larger effect than rTMS (SMD - 0.62; 95%CI, - 1.81 to 0.57) and nVNS (SMD - 1.39; 95%CI, - 3.27 to 0.49). tDCS had also the largest effect in reducing pain intensity when compared with sham intervention (SMD - 1.49; 95%CI, - 2.46 to - 0.52) and rTMS (SMD - 0.48; 95%CI, - 2.06 to 1.09). For the prophylactic treatment of migraine, tDCS was relatively more effective than rTMS and nVNS. Head-to-head comparison trials are needed to confirm the findings.

Efficacy of memantine compared with sodium valproate as prophylactic treatment for migraine: a controlled randomized pilot study

Aim: To compare the efficacy of memantine with that of valproate as a prophylactic treatment for episodic migraine within three months. The efficacy, safety, and response rate were evaluated. Methods: Prospective, randomized, double-blind, controlled clinical trial randomized participants were divided into two groups. The memantine group received memantine 10 mg twice daily, and the valproate group received valproate 500 mg twice daily. Results: Thirty-three patients participated in the study; 27 completed the treatment protocol, 14 in the memantine group, and 13 in the valproate group. The mean number of migraine attacks per month in the memantine group was 5.31 [standard deviation (SD) ± 1.54] initially and 0.93 (SD ± 1.49) at the end of treatment, noting a decrease of 4.21 (SD ± 1.76; P &lt; 0.001). In the valproate group, the mean number of migraine attacks per month was 5.35 (SD ± 1.11) initially and 0.77 (SD ± 1.16) at the end of treatment, with a difference of 4.5 (SD ± 1.39; P &lt; 0.001). All 27 patients had excellent response rates. Adverse effects were infrequent and mild in severity. Conclusions: A clinical trial compared the efficacy of memantine with that of valproate (first-line drug) as a prophylactic treatment. A significant reduction in attacks was noted in both drugs. Memantine could be a new preventive treatment option for migraine.