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The intranasal, small molecule CGRP receptor antagonist, zavegepant, has demonstrated a favourable safety and tolerability profile in a 1-year, phase 2/3 open-label safety study in acute migraine (NCT04408794). Of 608 people who entered the long-term treatment phase, 603 were treated with zavegepant 10 mg nasal spray for up to 52 weeks. The treated population had …

Extensive results from the Phase 3 PROGRESS trial of atogepant in chronic migraine prevention presented at MTIS 2022 included data showing early and sustained reductions in monthly migraine days (MMDs),1 and efficacy in patients with medication overuse.2 Modified intent-to-treat data from 755 participants with baseline MMDs from 18.6 to 19.2 showed mean MMD changes at …

Younger patients and those with fewer days of headache, without depression, with accompanying symptoms, or with a good response to triptans have responded best to galcanezumab in a real-world study of chronic migraine (CM) carried out in Korea. In the prospective study of 238 patients with CM with and without medication overuse, treated with monthly …

Many patients with chronic migraine (CM) taking fremanezumab revert to episodic migraine but nearly all need to continue treatment for a second year. This is the real-world experience of British migraine specialists who monitored the impact of fremanezumab treatment in 300 patients with CM. All patients had tried and failed at least six treatments, with …

First clinical evidence that cAMP-evoked migraine attacks act downstream of the CGRP receptor, apparently independent of CGRP-receptor activation, has been reported by Danish Headache Center researchers. “These findings open new avenues for mechanism-based drug development for migraine,” they conclude. In the study, the CGRP and phosphodiesterase 3 inhibitor, cilostazol, was used to provoke migraine in …

CGRP mAbs should be among first-line preventive treatments for migraine, with consideration given to which patients are most likely to benefit, levels of patient disability and medication costs. This was the broad consensus that emerged from a Controversies in Headache debate at the EAN 2022 congress, and it was in line with recommendations in the …

Eptinezumab treatment reduces monthly migraine days (MMDs) over weeks 1-12 of treatment compared to placebo in patients with episodic migraine (EM), chronic migraine (CM), medication overuse headache (MOH) or at least two previous treatment failures. These findings from exploratory analyses of selected sub groups of patients in the Phase 3b DELIVER trial of eptinezumab 100 …

Erenumab has shown sustained superior efficacy compared with standard of care (SOC) oral preventives in patients with episodic migraine (EM) who had previously failed one or two migraine preventives. Results of the APPRAISE global, prospective, randomised, open-label study in 621 patients with EM showed that a significantly higher proportion of patients stayed on erenumab at …

Daily headache was an exclusion criterion in registration trials of CGRP mAbs but is common in clinical practice. Results of a real world study of 47 patients with chronic migraine treated at the headache unit of a tertiary hospital have shown that patients respond to galcanezumab irrespective of whether they have daily headache. Patients had …

An interim analysis of data from the two-year Pan-European Real World (PEARL) prospective, observational study of fremanezumab has shown that 54.7% of patients with episodic or chronic migraine had a reduction in monthly migraine days (MMDs) of at least 50% over the six-month period from the start of treatment. Improvements were also seen in migraine-related …

Plasma CGRP levels more than doubled after six months treatment with erenumab, according to results of a study carried out in patients with migraine, the majority of whom had chronic migraine.1 In the 42 patients who took erenumab 70 mg for at least six months, the average number of headache days per month decreased from …

Migraine symptoms related to peripheral trigeminal sensitisation may predict response (>50%) and super-response (>75%) to anti-CGRP monoclonal antibodies (mAbs). In an analysis of 864 patients with high frequency episodic migraine (HFEM) or chronic migraine (CM), treated with erenumab, galcanezumab or fremanezumab for more than 24 weeks, unilateral pain (UP) + unilateral cranial autonomic symptoms (UAs) …

Nearly two thirds (63%) of patients with migraine who report at least four monthly headache days (MHDs) have never used preventive medication, according to data from the US cohort in the 2021 Chronic Migraine Epidemiology and Outcomes-International (CaMEO-I) study. A further 14.5% had discontinued preventive medication, and only 22.5% said they were currently on preventive …

More than 80% of patients with migraine who took rimegepant as both preventive and acute treatment achieved ≥50% reduction in moderate or severe monthly migraine days (MMDs) in weeks 49-52 of an open label extension (OLE) study reported at the congress.1 Through the 52 week OLE phase, MMD frequency consistently declined – by a mean …

Patients with episodic migraine who achieve an initial ≥50% reduction in monthly migraine days (MMDs) with atogepant generally sustain this response over 12 and 52 weeks of continued treatment, according to post hoc analyses of two Phase 3 trials of efficacy and safety (NCT03777059 and NCT03700320). In the 12-week, ADVANCE study, 70.8-81.1% of participants who …

Latest analysis of data from the COURAGE study of ubrogepant in combination with onabotulinumtoxinA has shown that seven out of 10 patients with high levels of migraine disability were satisfied with treatment. Of 116 patients, 81 (69.8%) were satisfied (16.7% extremely satisfied, 24.1% very satisfied, 19% satisfied). Of respondents, 86.9% had severe or very severe …

Growing evidence of the efficacy and tolerability of combined CGRP mAb and gepant treatment is emerging from clinical practice. Results of a retrospective chart review of 55 adult patients carried out at a New York practice showed that adding fremanezumab to gepant therapy reduced average monthly migraine days (MMDs) by -6.5 days (standard deviation [SD] …

A higher resilience score is inversely correlated with Migraine Disability Assessment (MIDAS) score, and greater levels of anxiety and depression are associated with increased levels of headache-related disability. In a study carried out to explore discordance between MIDAS scores and functional ability in practice, 160 patients with primary headache disorders completed five validated measures in …

Vydura (rimegepant) has received EU marketing authorisation in the acute treatment of migraine with or without aura, and for the prophylaxis of episodic migraine in adults who have at least four migraine attacks per month. Vydura orally disintegrating tablet is the first medicine approved for both acute and prophylactic treatment of migraine in the EU. “Vydura’s …

Significant reductions in opioid use and in medication overuse headache (MOH) have been reported from an analysis of prescription claims data from a longitudinal commercial pharmacy database in the months following rimegepant initiation for migraine. Eighteen month follow up data for the opioid use analysis showed a 16.06% reduction in total opioid prescriptions filled in …

Atogepant appears to partially prevent activation of both Aδ- and C-fibre meningeal nociceptors, according to results of a mechanistic study using single-unit recordings of activity in trigeminal ganglion neurons innervating the dura in response to cortical spreading depression (CSD). Atogepant did not fully prevent activation of nociceptors (incidence of response to CSD in Aδ-fibres [vehicle 73%, …

When a patient with migraine starts ubrogepant whilst their pain is mild, they are more likely to be free of pain and other symptoms after two hours than if they delay until their pain is moderate or severe. This is the conclusion of a post-hoc, within-person analysis of efficacy data from patients who treated at …

Post-hoc analyses of data from studies of atogepant for migraine prevention have shown treatment-related, dose-dependent reductions in body weight compared with placebo and standard care.  In the ADVANCE trial, least squared (LS) mean percentage change in body weight from baseline to 12 weeks was +0.37 with placebo versus +0.14 (p=0.4138), -0.61 (p=0.0005), and -1.27 (p<0.0001) …

Patients with chronic migraine (CM) who reduce attacks to four or fewer monthly headache days achieve superior outcomes, with least need for acute medication. This is the conclusion of a post hoc analysis of data from the PROMISE-2 trial evaluating eptinezumab for CM prevention. The analysis showed that, of patient-months with ≤4 MHDs, 67.6% (561/830) …

Fremanezumab treatment resulted in clinically meaningful reductions in monthly migraine days (MMD) and significant improvements in disability outcomes in patients with prior onabotulinumtoxinA treatment failure. These were the findings from pooled data from the Phase 3 HALO EM, HALO CM, and FOCUS trials in which patients were randomized 1:1:1 to quarterly or monthly fremanezumab or …

Safety and efficacy data from the DRAGON study of erenumab 70 mg in adult patients with chronic migraine in China and other Asian countries are consistent with previous pivotal studies. In the 12-week Phase 3 study of 557 patients with chronic migraine, those in the erenumab 70 mg group had a significantly greater reduction in …

Intranasal zavegepant in doses up to 40mg per day has demonstrated good safety and tolerability in healthy adults, with doses ≥10 mg producing exposures predictive of efficacy in adults with migraine.1 These results from two Phase 1, placebo-controlled, randomised, double-blind, sequential zavegepant studies provide supportive data following previous reports of Phase 3 data demonstrating significantly …

High completion rates and sustained safety and tolerability were reported from an open access programme for galcanezumab in patients who completed the 3-month double-blind and 9-month open-label phases of the Phase III REGAIN trial (NCT02614261). Patients entered the three year continuous access programme for galcanezumab approximately five to 13 months after their last study dose. …

Qulipta (atogepant) significantly reduced mean monthly migraine days (MMDs) compared to placebo in adult patients with chronic migraine (CM), according to data announced from the Phase 3 PROGRESS trial. The results will support a submission to expand the use of atogepant to include preventive treatment of CM in the USA. The drug was approved for …

Rimegepant 75 mg orally dissolving tablet is likely to get the go ahead for EU approval, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) which advises the European Medicines Agency (EMA) on product approvals. Following a CHMP opinion, an approval decision is generally made within 10 weeks. The positive …

Professor Fernando Kowacs considers which patients may benefit from CGRP monoclonal antibodies and describes the factors that influence his choice of drug for individual patients as well as his approach to follow up, and his switching strategies for poor responders.     < Previous page

Top-line data from a Phase 3 rimegepant trial for the acute treatment of migraine in 1,431 adult patients in China and South Korea have shown that the study met its co-primary endpoints. Two hours after a single dose of rimegepant 75 mg orally dissolving tablet, significant improvements were seen compared to placebo in freedom from …

Vyepti (eptinezumab) has received approval by the European Medicines Agency for migraine prevention in EU countries and will be the first intravenous CGRP monoclonal antibody (mAb) treatment available in Europe. Like other CGRP mAbs, eptinezumab has been approved for prophylactic treatment of migraine in adults who have at least four migraine days per month. The …

Top-line Phase 3 data on the investigational, intranasal agent, zavegepant, as acute treatment of migraine have demonstrated significantly greater improvement in pain freedom and most bothersome symptom than placebo. The study achieved its co-primary regulatory endpoints of pain freedom (zavegepant 24% vs placebo 15%, p<0.0001) and freedom from most bothersome symptom (zavegepant 40% vs placebo …

Patients with episodic migraine are being enrolled in CHALLENGE-MIG – a Phase 4, head-to-head study of the CGRP mAb injection, galcanezumab, and the oral gepant, rimegepant. The primary endpoint is the percentage of patients with ≥50% reduction from baseline in monthly migraine headache days. Secondary endpoints include quality of life and migraine disability improvements and …

Full data from the HER-MES trial showing that significantly fewer patients with episodic or chronic migraine discontinued erenumab 70 or 140 mg/month than topiramate 50-100 mg/day, and more patients achieved > 50% reduction in monthly migraine days (MMDs), have been published in Cephalgia. In the Phase 4, 24-week study which enrolled 777 adult patients, 10.6% …

Identifying patients most likely to respond to CGRP mAbs will be key to improving access to this important group of new drugs, and a study in Italy, Germany and Spain is investigating an array of demographic, clinical, psychological, cognitive, epigenetic, pharmacogenetic, biochemical and imaging markers. “We are not expecting to see a single biomarker that …

There is no difference in efficacy between ligand- and receptor-binding CGRP mAbs and there is no evidence that any one mAb works better than another, agreed speakers in response to questions at a joint session of the World Federation of Neurology and the International Headache Society. “Based on Phase 3 clinical studies, we don’t see …

One in three patients treated with erenumab at an Italian centre reverted from chronic to episodic migraine after one month, and 71% by the end of one year of treatment, reported Dr Gloria Vaghi, from the University of Pavia, Italy. The real world study, in 82 patients with chronic migraine who had failed on at …

Reduction in migraine headache days in patients treated with fremanezumab in Korea compares well with reductions seen in the pivotal Phase 3 HALO studies in episodic and chronic migraine. Results of two phase 2b/3 studies in Korea, with the same design as the HALO trials, showed similar reductions in monthly headache days (MHDs) and responder …

Nearly six out of 10 patients with chronic migraine had a significant clinical response to erenumab or galcanezumab in the first four weeks of treatment in a retrospective real world study reported from ASST Spedali Civili Brescia, Italy. Of the 74 consecutive patients who were enrolled, 64 had documented medication overuse, and 50 patients were …

Patients taking CGRP mAbs are less likely to discontinue treatment within 12 months than those taking other approved preventive therapies for migraine, according to US claims data from over 4,500 patients prescribed CGRP mAbs and nearly 11,000 taking other preventives. Over a 12-month follow-up, 58.8% of CGRP mAb and 77.6% of non‑CGRP initiators discontinued therapy …

The US Food and Drug Administration (FDA) has approved the oral CGRP receptor antagonist, Qulipta (atogepant) for the preventive treatment of episodic migraine in adults. The drug will be available as once-daily treatment in three doses – 10 mg, 30 mg and 60 mg. The approval is supported by data evaluating the efficacy, safety and …

Since the US approval of the first gepant for the acute treatment of migraine in December 2019, clinicians have been reporting their experiences of combining these agents with CGRP monoclonal antibodies (mAbs) in some patients. Richard Lipton, Edwin S Lowe Professor of Neurology at the Albert Einstein College of Medicine, New York, USA, discusses the …

Real world studies are showing that CGRP mAbs are effective in significant patient groups excluded from randomised controlled trials (RCTs). They are also helping to identify predictors of treatment response and are extending understanding of safety issues. Professor Uwe Reuter, from the Charité University Berlin and the University of Greifswald, Germany, discussed data from the …

Stopping preventive treatment with CGRP mAbs typically leads to worsening migraine symptoms and, in some cases, a rebound effect, according to reports from clinicians in Germany, Portugal and Italy. Results of a German longitudinal study of 62 patients who received erenumab, fremanezumab or galcanezumab for at least eight months showed that mean monthly migraine days …

Twelve month data from the HALO study and six month results from the FOCUS study have shown few blood pressure-related adverse events with fremanezumab and minimal changes in systolic blood pressure (SBP) or diastolic blood pressure (DBP). In HALO, one patient had increased DBP and one had decreased SBP, both with quarterly fremanezumab. Mean blood …

Erenumab and galcanezumab have demonstrated similar efficacy and safety as preventive treatment in a very difficult-to-treat migraine population in Spain. Data were reported on 220 patients, 89% of whom had chronic migraine. Patients had failed on a mean 5.74 previous preventive therapies. With erenumab, monthly headache days (MHDs) decreased from 20.94 days at baseline to …

Long term acute treatment of migraine with rimegepant 75 mg as needed is associated with clinically relevant reductions in monthly migraine days (MMDs), according to post hoc results from an open label, 52-week safety study. There was no evidence of medication-related increases in headache frequency. In the study of 1,044 participants with ≥6 MMDs, the …

Real world experience from multiple new reports worldwide supports the use of CGRP mAbs in the treatment of cluster headache. From Korea, researchers reported results from 45 patients with episodic cluster headache who received at least one dose of galcanezumab 240 mg in two prefilled syringes of 120 mg.1 Patients took a range of preventive …