Trial reportThe journal of headache and pain2021
Efficacy and safety of fremanezumab in patients with migraine and inadequate response to prior preventive treatment: subgroup analyses by country of a randomized, placebo-controlled trial.
Trial report in The journal of headache and pain, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03308968 (A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study With an Open-Label Period to Evaluate the Efficacy and Safety of Fremanezumab for the Prophylactic Treatment of Migraine in Patients With Inadequate Response to Prior Preventive Treatments), which is not on this map. Cited by 3 papers.
What it found
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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.
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study With an Open-Label Period to Evaluate the Efficacy and Safety of Fremanezumab for the Prophylactic Treatment of Migraine in Patients With Inadequate Response to Prior Preventive Treatments
Who cites it
3 citing papers in PubMed, 12 citations in OpenAlex.
- Effect of acupuncture combined with auricular beanembedding on autonomic nervous system function, heart rate variability and mental state of migraine patients.American journal of translational research · 2024Article
- A Scoping Review and Meta-Analysis of Anti-CGRP Monoclonal Antibodies: Predicting Response.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Breakthroughs on the clinical management of headache and questions that need to be solved.Ibrain · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe FOCUS study evaluated the efficacy of migraine preventive medications across different countries within the same patient population, particularly for patients with difficult-to-treat migraine. These prespecified subgroup analyses evaluated efficacy by country in the FOCUS study of fremanezumab in adults with episodic migraine or chronic migraine and documented inadequate response to 2 to 4 migraine preventive medication classes.
methodsOverall, 838 participants were enrolled in the FOCUS study, a randomized, double-blind, placebo-controlled, parallel-group, phase 3b study performed at 104 sites. For 12 weeks of double-blind treatment, patients were randomized (1:1:1) to quarterly fremanezumab, monthly fremanezumab, or matched placebo. The primary efficacy endpoint was the mean change from baseline in monthly average migraine days over 12 weeks of double-blind treatment, evaluated by country in these subgroup analyses.
resultsOf 14 countries contributing data, the Czech Republic (n = 188/838; 22%), the United States (n = 120/838; 14%), and Finland (n = 85/838; 10%) enrolled the most patients. Changes from baseline in monthly average migraine days over 12 weeks were significantly greater with fremanezumab versus placebo for patients in these countries: Czech Republic (least-squares mean difference versus placebo [95% confidence interval]: quarterly fremanezumab, - 1.9 [- 3.25, - 0.47]; P = 0.009; monthly fremanezumab, - 3.0 [- 4.39, - 1.59]; P < 0.001), the United States (quarterly fremanezumab, - 3.7 [- 5.77, - 1.58]; P < 0.001; monthly fremanezumab, - 4.2 [- 6.23, - 2.13]; P < 0.001), and Finland (quarterly fremanezumab, - 3.0 [- 5.32, - 0.63]; P = 0.014; monthly fremanezumab, - 3.9 [- 6.27, - 1.44]; P = 0.002). Results were comparable for the remaining 9 countries, with the least-squares mean difference versus placebo ranging from - 5.6 to - 2.4 with quarterly fremanezumab and from - 5.3 to - 1.5 with monthly fremanezumab. Incidences of serious adverse events and adverse events leading to discontinuation were low and comparable across countries and treatment groups.
conclusionsMonthly and quarterly fremanezumab significantly reduced the monthly average number of migraine days versus placebo regardless of country and continent (North America versus Europe) in migraine patients with documented inadequate response to 2 to 4 migraine preventive medication classes.
trial registrationClinicalTrials.gov Identifier: NCT03308968 .
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