Trial reportHeadache2021
Efficacy and safety of fremanezumab for episodic migraine prevention: Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients.
Trial report in Headache, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 9 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
47 citing papers in PubMed, 9 syntheses or guidelines pooled it, 105 citations in OpenAlex.
- Repurposed versus disease-specific medicinals for the prophylaxis of migraine: an updated systematic review.Pain management · 2025Pooled it
- Increased infection risk in patients on preventive CGRP-targeting therapies- a meta-analysis and clinical effect assessment.The journal of headache and pain · 2025Pooled it
- CROATIAN GUIDELINES FOR SPECIFIC PREVENTIVE TREATMENT OF MIGRAINE WITH MONOCLONAL ANTIBODIES TARGETING CALCITONIN GENE-RELATED PEPTIDE (CGRP) (EPTINEZUMAB, FREMANEZUMAB, AND GALCANEZUMAB) OR THE CGRP RECEPTOR (ERENUMAB).Acta clinica Croatica · 2024Guideline
- Preventive drug treatments for adults with chronic migraine: a systematic review with economic modelling.Health technology assessment (Winchester, England) · 2024Pooled it
- Methodological considerations on real-world evidence studies of monoclonal antibodies against the CGRP-pathway for migraine: a systematic review.The journal of headache and pain · 2023Pooled it
- The comparative effectiveness of migraine preventive drugs: a systematic review and network meta-analysis.The journal of headache and pain · 2023Pooled it
- The temporal trend of placebo response in migraine prevention from 1990 to 2021: a systematic literature review and meta-analysis with regression.The journal of headache and pain · 2023Pooled it
- Gender bias in clinical trials of biological agents for migraine: A systematic review.PloS one · 2023Pooled it
- European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention - 2022 update.The journal of headache and pain · 2022Guideline
- Trial
- Early onset of efficacy with fremanezumab in patients with episodic and chronic migraine: subanalysis of two phase 2b/3 trials in Japanese and Korean patients.The journal of headache and pain · 2022Trial
- Long-Term Safety and Tolerability of Fremanezumab for Migraine Preventive Treatment in Japanese Outpatients: A Multicenter, Randomized, Open-Label Study.Drug safety · 2021Trial
- Trial
- Patient Preferences Toward CGRP-Targeting Preventive Migraine Treatments in Japan: Discrete Choice Experiment.Neurology and therapy · 2026Article
- Evaluating the Complementary Nature of Randomized Controlled Trials and Real-World Evidence Using Over 5 Years of Experience with Fremanezumab: A Narrative Review.Advances in therapy · 2026Review
- Three-Year Interim Results from a Post-Marketing Surveillance Study of Patients with Migraine Treated with Fremanezumab in South Korea.Drugs - real world outcomes · 2026Article
- Current landscape of migraine care with expert consensus from East Asia.The journal of headache and pain · 2026Review
- Use of CGRP Monoclonal Antibodies in Japan, South Korea, and Taiwan: A Narrative Review.Current pain and headache reports · 2026Review
- Drugs for Migraine Prophylaxis.Deutsches Arzteblatt international · 2026Review
- Migraine Management in Japan: Current Approaches and Science Narrative Including an Evidence-based Review.Internal medicine (Tokyo, Japan) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the efficacy and safety of two dosing regimens of fremanezumab in Japanese and Korean patients with episodic migraine.
backgroundEpisodic migraine, which accounts for more than 90% of migraine cases, is inadequately addressed by widely available preventive therapies. Fremanezumab, a monoclonal antibody that selectively targets the trigeminal sensory neuropeptide calcitonin gene-related peptide involved in migraine pathogenesis, has demonstrated efficacy in international Phase 3 trials of patients with both chronic and episodic migraine.
methodsThis Phase 3 randomized, placebo-controlled trial randomly assigned patients with episodic migraine to receive subcutaneous fremanezumab monthly (225 mg at baseline, week 4, and week 8), fremanezumab quarterly (675 mg at baseline and placebo at weeks 4 and 8), or matching placebo. The primary endpoint was the mean change from baseline in the monthly average number of migraine days during the 12-week treatment period after the first dose.
resultsOf 357 patients enrolled (safety set, n = 356; full analysis set, n = 354), the least-squares mean (±standard error) reductions in the average number of migraine days per month during 12 weeks were significantly greater with fremanezumab monthly (-4.0 ± 0.4, n = 121) and fremanezumab quarterly (-4.0 ± 0.4, n = 117) than with placebo (-1.0 ± 0.4, n = 116; p < 0.0001 for both comparisons). The proportion of patients reaching at least a 50% reduction in the monthly average number of migraine days during the 12-week period after initial administration was also significantly improved with fremanezumab (fremanezumab monthly, 41.3%; fremanezumab quarterly, 45.3%; placebo, 11.2%; p < 0.0001 for both comparisons) as were other secondary endpoints (p < 0.001 for all comparisons between fremanezumab and placebo). Injection-site reactions were more common in fremanezumab-treated patients (fremanezumab monthly, 25.6%; fremanezumab quarterly, 29.7%; placebo, 21.4%).
conclusionFremanezumab prevents episodic migraine in Japanese and Korean patients to a similar extent than in previously reported populations with no new safety concerns.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.