Trial reportThe patient2026
Experiences of Migraine and Erenumab Treatment in Japan: Qualitative Interviews with Clinical Trial Participants.
Trial report in The patient, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03812224 (A Phase 3 Japanese Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention), which is not on this map. Not yet cited in PubMed.
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A Phase 3 Japanese Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention
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13 authors.
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Abstract
backgroundIn Japan, migraine is estimated to affect 6-8.6% of the population, and the burden of migraine and barriers to migraine care are substantial. Although new preventive treatments are available for migraine, there is limited qualitative information about the lived experience of adults with migraine in Japan and how these treatments improve their day-to-day lives.
methodsParticipants in a qualitative interview study embedded in a phase 3 randomized, double-blind, placebo-controlled clinical trial (NCT03812224) were invited to take part in a telephone interview after completing 24 weeks of double-blind treatment with once-monthly erenumab 70 mg and a subsequent 28-week open-label treatment period. Interviews were conducted by Japanese interviewers using a semi-structured interview guide. The interviews were audio-recorded, transcribed, and qualitatively analysed using a thematic content analysis approach.
resultsForty-one participants were interviewed between May and September 2020. The mean age of participants was 43.8 years; 82.9% were female, 51.2% had episodic migraine, and 48.8% had chronic migraine. Prior to trial participation, patients identified pain, nausea, and profound tiredness-often expressed as a "lack of energy" or feeling "exhausted" or "drained"-as the most bothersome symptoms. Patients also emphasized difficulties concentrating, interference with school, work, and household responsibilities, and emotional strain as the most bothersome impacts of living with migraine. At the end of the trial, patients reported important improvements in their migraine experience-such as reductions in migraine frequency, severity, and duration-which translated into tangible benefits in daily life. Overall, satisfaction with erenumab was high (mean score 6.8 on a 0-10 scale) and was mainly driven by the reduced frequency and duration of migraine.
conclusionResults from this qualitative study confirm that migraine significantly impacts the quality of life of adults in Japan. This study provides valuable insights into patients' experiences of erenumab, which reduced the frequency, severity, or duration of migraine episodes in most patients, resulting in better functioning and overall quality of life.
trial registrationClinicaltrials.gov NCT03812224. Registered January 23, 2019.
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