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Over half of patients with migraine-related cognitive symptoms reported improvements in all domains in the prospective real-world INFUSE study of 190 participants who had failed on at least one previous CGRP-targeted preventive therapy. At baseline, 93.7% (178/190) reported brain fog, 78.9% (150/190) reported difficulty making decisions, 82.6% (157/190) reported difficulty reading, and 82.6% (157/190) reported …

Results of the Phase 3, open label UNCHAINED study have shown that adding atogepant 60 mg to onabotulinumtoxinA 155-200U in patients with chronic migraine was associated with consistent increases in cardinal and complete migraine symptom-free days over 24 weeks of treatment (NCT05216263). In the modified intention-to-treat population of 72 patients, incremental symptom burden days from …

Primary care physicians (PCPs) account for only one in five gepant prescriptions despite seeing the majority of patients with migraine, report US headache specialists. In a study examining gepant prescribing at the University of Washington, a tertiary academic medical centre with dedicated headache specialists and multiple primary care clinics, 145 patients were identified who were …

Exposure to CGRP mAbs during pregnancy is associated with a nearly 50% increased risk of spontaneous abortion before 20 weeks, according to results of a Canadian retrospective cohort study of 11,819 pregnancies in women with pregestational migraine. Of these, 319 (2.7%) were exposed to anti-CGRP mAbs (+/-propranolol), 299 to propranolol (without anti-CGRP mAb), and 11,201 …

The PACAP-targeting monoclonal antibody, bocunebart, significantly reduces monthly migraine days (MMDs), according to results of the Phase 2b, dose-finding PROCEED trial with patients who had failed at least 1 to 4 different migraine preventive medications in the previous 10 years and had at least 4 migraine days per month for each month in the 3 …

Encouraging Phase 1 pharmacokinetic data for the investigational TRPM8-targeting agent, elismetrep, have shown more rapid absorption with a novel liquid-filled softgel capsule (LSGC) than with the dry-filled capsule (DFC) formulation used in the Phase 2b study of the agent.1 In the study, median time to maximum concentration [Tmax] was 1 hour with the LSGC formulation …

The European Commission has approved Aquipta (atogepant) for the acute treatment of migraine in adults, with or without aura, adding to its previous EU approval for the prophylaxis of migraine in adults who have at least four migraine days per month. The new approval is supported by data from the Phase 3 ECLIPSE trial, which …

Patients with cardiovascular (CV) risk factors taking atogepant 60 mg QD for migraine prevention maintain weight loss during 12 months of treatment, according to interim results from an open label extension of the Phase 3 ELEVATE and PROGRESS trials in episodic migraine (EM) and chronic migraine (CM), respectively. In the analysis of 279 patients who …

Hypertension history appears to modify the blood pressure response to anti-CGRP therapies, with patients with prior hypertension seeming to remain stable or improve and previously normotensive individuals experiencing a modest increase in systolic blood pressure (SBP). These intriguing findings reported by Dr Suresh Kumar and colleagues from the University of Austin, Texas, have emerged from …

The developmental anti-PACAP antibody, Lu AG09222 (bocunebart), was well tolerated when co-administered with ubrogepant and did not alter ubrogepant pharmacokinetics, results of a Phase 1 study in patients with episodic migraine have shown. In the randomised, double-blind, placebo-controlled study at four US sites, 43 adults aged 18-65 years with ≥2 monthly migraine days, and <15 …

CGRP reliably provokes typical headache attacks and increases intracranial pressure (ICP) pulse amplitude in patients with idiopathic intracranial hypertension (IIH), without altering mean pressure, providing mechanistic support for CGRP in IIH and justifying evaluation of CGRP blockade in this population. This is the conclusion of Dr Andreas Yiangou, from the University of Birmingham, UK, and …

Fremanezumab does not reduce migraine days in children and adolescents with chronic migraine (CM) – in contrast to the beneficial effects seen in paediatric studies of episodic migraine (EM). In the Phase 3 SPACE CM trial of fremanezumab in 298 patients with CM (≥15 headache days per month), aged 6-17 years, there was no significant …

Rimegepant treatment every other day has been shown to improve headache frequency and severity in patients with cluster headache after one week of use. Most patients were very satisfied or somewhat satisfied with rimegepant and wanted to use it again. These findings were reported from a pilot study of 20 patients who met criteria for …

The introduction of CGRP mAbs has transformed migraine prevention1, but despite the long half-lives and sustained efficacy of these agents in clinical trials, concerns have emerged in real-world practice regarding the perceived “wearing-off” phenomenon, defined as a recurrence or worsening of migraine headaches towards the end of the dosing interval. Dr Reem Suliman and Dr …

A new Position Statement from the American Headache Society (AHS) proposes annual migraine screening for women as part of their preventive healthcare services, particularly from adolescence to menopause. The recommendation comes after a review of published literature showed that migraine meets established criteria for disease screening, ie: The disease or condition must be common and …

The investigational anti-PACAP mAb, bocunebart (Lu AG09222), significantly reduces monthly migraine days (MMD), according to top-line data from the Phase 2b dose-finding PROCEED trial with bocunebart i.v. in 431 patients from 14 countries. Reductions in MMD with bocunebart i.v. compared with placebo have been reported over weeks 1-12 in patients with migraine who had experienced …

Adding atogepant to ongoing onabotulinumtoxinA (BoNTA) led to meaningful reductions in migraine frequency, acute medication use, and disability in the real world SYNERGY study in patients with chronic migraine (CM). In the prospective analysis, 82/101 adult patients with CM who had received at least three prior BoNTA cycles completed 24 weeks of co-treatment with atogepant …

Approximately one in 10 people with migraine switches between anti-CGRP therapies in their first year of treatment. This is the finding from an analysis of US prescription claims data for 148,100 adults who had at least one prescription dispensed for an anti-CGRP agent (mAbs and gepants) as preventive treatment for migraine between May 2018 and …

It’s been an impressive year for migraine initiatives aimed at raising standards of care for patients, and for clinical studies designed to enhance the use of CGRP-targeted therapies. Here’s our quick rewind on key progress in 2025.   New clinical trial data Primary data from the Phase 3 ECLIPSE trial showing the efficacy of atogepant …

Primary data from the Phase 3 ECLIPSE trial in patients with migraine with or without aura have shown that atogepant 60 mg was superior to placebo in achieving pain freedom at 2 hours post dose. In the study, 146/602 (24.3%) of atogepant-treated participants were pain-free at 2 hours compared to 80/612 (13.1%) of those in …

Leading international migraine specialists have proposed new definitions of a migraine day to the International Headache Society for inclusion in the International Classification of Headache Disorders (ICHD).1The aim is to standardise definitions used in clinical trials and clinical practice and avoid the variability in terminology highlighted in a recently published analysis of Phase 3 clinical …

Switching patients who have failed on a first CGRP mAb to a second CGRP mAb or a gepant achieves similar outcomes, with a trend towards a higher clinical response and better tolerability with a gepant, according to results of a retrospective observational study of patients treated at a tertiary Headache Unit in Spain between May …

Ubrogepant maintains comparable efficacy and safety profiles irrespective of concurrent CGRP mAb use, according to results of the Phase 4 UNION trial. In the prospective, open label study, 165 participants were randomised to ubrogepant 50 mg or 100 mg, either alone or in combination with a CGRP mAb. In patients taking ubrogepant 50 mg or …

Women who use CGRP mAbs during pregnancy may be at increased risk of hypertensive disorders and pre-eclampsia, though wide confidence intervals for risk ratios (RRs) make it difficult to draw firm conclusions. This is the main finding from a population-based study of women with chronic migraine registered in the nationwide Medical Birth Registry of Norway …

An analysis of long term efficacy of CGRP mAbs in 223 patients with chronic or episodic migraine (62% and 29% respectively) or new daily persistent headache with migraine phenotype (9%), at a large UK centre has shown that approximately three quarters had a >30% response and this was most likely in triptan responders and older …

Many patients with migraine who fail to meet CGRP mAb reimbursement criteria after six months therapy do go on to achieve significant benefits if allowed to continue treatment, according to real world data from a multicentre headache unit in Spain. In the study, results were compared from patients who did not achieve ≥50% reduction in …

Four main barriers to accessing newer preventive therapies for migraine have been identified by an American Migraine Foundation (AMF) multidisciplinary expert panel: 1) restrictive prior authorisation requirements, 2) a perceived lack of real-world evidence and treatment guidelines, 3) the need for clinician education, and 4) the need for patient education. The panel, which included neurologists …

Super responders (≥ 75% response) and absolute responders (100% response) often emerge after more than three months of CGRP mAb therapy, according to results of a recent multicentre, real world study of 572 patients with high frequency (HFEM) or chronic migraine (CM) who completed 12 months of treatment. At the end of the study, 70.0% …

Concerns about rare reports of inflammatory complications with CGRP mAb treatment have been explored in a study evaluating the plasma cytokine profile of a cohort of 22 patients with chronic migraine and 10 healthy controls, before and after taking CGRP mAbs. The prospective cohort study used Simoa CorPlex human cytokine 10-plex to measure interferon gamma …

Further evidence that fewer patients are likely to meet recent International Headache Society (IHS) targets1 for migraine prevention than the ≥50% reduction in monthly migraine days (MMDs) typically used to assess treatment response, comes from an observational study of 62 patients followed up at a tertiary migraine centre in Portugal.2 Most patients were treated with …

The efficacy of a once-daily (QD) dose of rimegepant 75 mg appears more robust than the current every other day (EOD) dosing regimen for prevention of episodic migraine, conclude investigators for a large, placebo-controlled trial of the efficacy and safety of the two dosing regimens (NCT05217927). In the multicentre study, 699 patients were randomised to …

Elevated baseline plasma CGRP and interleukin 1β (IL-1β) expression have shown promise in helping to identify patients more likely to benefit from erenumab. Data from the BIOMIGA project (NCT04503083) in 164 participants, 38% with chronic migraine (CM), and 62% with highly frequent episodic migraine (HFEM), were reported at the congress. Median monthly headache days (MHDs) …

Clinical trial participants are likely to spontaneously talk about common migraine symptoms but need more probing questions to report cognitive symptoms, according to results of interviews with 50 participants in the Phase 2 HOPE trial of the anti-PACAP mAb, Lu AG09222. Optional, semi-structured interviews were conducted up to 14 days after the safety follow-up visit …

Preliminary findings from the ATOM project (NCT06882122) have shown that clinical improvement in response to atogepant in patients with high-frequency episodic migraine (HFEM) is associated with modulation of the endocannabinoid system and specific microRNAs (miRNAs). In the prospective study involving 18 patients with HFEM (8–14 migraine days per month [MMDs]) treated with daily atogepant 60 …

Real-world experience of galcanezumab use for chronic migraine (CM) prevention at a UK migraine clinic has confirmed that few responders can achieve remission and most relapse if they stop treatment. In the study, 125 patients with CM (mean age 42.5 years [range 21-75]) started galcanezumab between January and May 2022. They had failed an average …

A post hoc analysis from the PEARL study (EUPAS35111) has shown that patients taking fremanezumab at early disease stages may have better migraine outcomes than those who wait for the CGRP mAb until they have chronic migraine (CM) or have failed on three other types of treatment. In the analysis of data from 1,128 patients …

Meaningful and sustained reductions in monthly migraine days (MMDs) have been reported across three consecutive one-year cycles of CGRP mAb treatment, though a remaining high burden of disease highlights the need to explore non-CGRP dependent pathways. These are the findings of a prospective, real-world study of 179 patients, 87.2% with chronic migraine and medication overuse, …

Ajovy (fremanezumab) has been approved in the USA for the preventive treatment of episodic migraine in children and adolescents aged 6-17 years who weigh 45 kilograms (99 pounds) or more. This makes fremanezumab the first anti-CGRP therapy with both paediatric and adult indications. Data from the Phase 3 SPACE trial in 237 participants aged 6-17 …

Attitudes to migraine and the way it is discussed may be changing following the introduction of new treatments such as anti-CGRP therapies.1 An analysis of the impact of language guidelines from the Coalition for Headache and Migraine Patients (CHAMP) and the American Migraine Foundation (AMF)2 on stigmatising language in migraine-related social media posts has shown …

Further data supporting dual CGRP mAb/gepant therapy for migraine prevention in treatment-resistant patients comes from a small retrospective, real-world study of CGRP mAbs and gepants carried out through the University of Vermont Health Network, including data from January 1, 2020 through December 31, 2024.1 This follows previously reported results suggesting that dual therapy can reduce …

Preliminary data from a retrospective chart review of adolescents who were treated simultaneously with anti-CGRP agents and onabotulinumtoxinA for refractory headache have shown promising additive benefit compared to monotherapy. The results are from 55 patients with a median age of 16.4 years (IQR 15.5-16.9), treated at a US tertiary care paediatric headache clinic between 2020 …

Real-world data from health records of patients treated with anti-CGRP therapies for the first time at Jefferson Headache Center, Philadelphia, USA, between January 2018 and May 2025 have shown negligible effects on blood pressure during 12 months follow up compared with controls.  Small effects on body mass index (BMI) were seen with some agents. Of …

Retrospective, real-world, patient-reported outcomes data support the use of intranasal zavegepant in acute migraine treatment. Of the 60 patients who had used intranasal zavegepant 10 mg at least twice (median nine doses) and were surveyed using the migraine treatment optimisation questionnaire-5 (MTOQ-5), 27 (45.0%) reported pain freedom within 2 hours of most attacks half the time …

CT-132, the app-based support tool that integrates multiple evidence-based behavioural techniques, including elements of cognitive behavioural therapy, has been shown to boost the efficacy of anti-CRGP therapies in patients with episodic migraine. In the 12-week, Phase 3 bridging study, Reduction in Monthly Migraine Days (ReMMiD-C), CT-132 reduced monthly migraine days (MMDs) compared to a sham …

Optimal migraine control and migraine freedom, as defined in the International Headache Society goals for migraine prevention published earlier this year, are achieved in real-world settings with CGRP mAbs in approximately 40% of individuals with a high migraine burden. This finding from a European prospective, real-world study, including adults with migraine treated with CGRP mAbs …

Early use of eptinezumab together with patient education about medication overuse headache (MOH) significantly reduces mean monthly migraine days (MMDs) in patients with chronic migraine (CM) and MOH, compared with education alone, according to results of the Phase 4 RESOLUTION trial. Of 608 participants randomised, 596 (98.0%) completed the 12-week, placebo controlled period of the …

CGRP mAb therapy is proving as effective in Ukraine as around the world, but patients are experiencing considerable challenges in accessing treatment. Single centre data on 47 patients treated with fremanezumab since 2021, reported by Drs Nayaliya and Myroslav Bozhenko at Danylo Halytsky Lviv National Medical University, have shown that 28 (59.6%) patients achieved a …

GLP-1 receptor agonists used to treat diabetes may also have beneficial effects for people with migraine through an indirect effect on CGRP release. Results of a small study in 26 adults with obesity and chronic migraine showed that the GLP-1 agonist, liraglutide, reduced mean monthly headache days from 20.04±6.38 to 8.81±6.01 (mean difference 11.23, p<0.001), …

CGRP mAb therapy was effective in patients diagnosed with chronic migraine (CM) refractory to onabotulinumtoxinA (BoNT-A), with high levels of compliance and safety after six months of treatment. These were the outcomes of the Re-MATE (Real-Migraine Antibodies Treatments Evidence) observational, retrospective study in 70 patients with CM previously treated for 12.7+2.4 months with BoNT-A. After …

CGRP mAb treatment is more effective in reducing migraine frequency outside the perimenstrual phase than during the perimenstrual period, according to results of a retrospective cohort analysis of 29 women, 11 of whom had episodic and 18 of whom had chronic migraine. The women met the ICHD-3 criteria for either pure menstrual migraine or menstrually …