✓ Translated by DotMD AI Clinical Council Source: The journal of headache and pain • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #41275111 ↗

Phase III Randomized Trial: Long-term tolerability and effectiveness of eptinezumab in Japanese adults with chronic migraine: results of the 60-week open-label SUNSET trial

Original Paper Title: “Long-term tolerability and effectiveness of eptinezumab in Japanese adults with chronic migraine: results of the 60-week open-label SUNSET trial”

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
Systematic Review
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • These results confirm the effectiveness of eptinezumab in Japanese participants with CM to reduce the burden of migraine and improve the ability to undertake daily life activities. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT05064371; date of registration: September 22, 2021)
  • Study Design & Sample: Phase III Randomized Trial published in The journal of headache and pain (Multi-cohort synthesis).
  • Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in The journal of headache and pain (2025), this phase iii randomized trial evaluating human clinical outcomes investigated: BACKGROUND: In the phase 3 SUNRISE trial conducted in a predominantly Asian population with chronic migraine (CM), eptinezumab (100 or 300 mg) met the primary and all key secondary endpoints and was well-tolerated. Key clinical takeaway: These results confirm the effectiveness of eptinezumab in Japanese participants with CM to reduce the burden of migraine and improve the ability to undertake daily life activities. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT05064371; date of registration: September 22, 2021)

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (The journal of headache and pain, 2025-11-22; Phase III Randomized Trial; Rigor 88/100): These results confirm the effectiveness of eptinezumab in Japanese participants with CM to reduce the burden of migraine and improve the ability to undertake daily life activities. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT05064371; date of registration: September 22, 2021)

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Condition: headache-associated-with-sexual-activity → Condition: primary-cough-headache →
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