NCT04151472RecruitingPhase 3
Idebenone for the Preventive Treatment of Migraine
A Randomized, Double-blinded, Placebo-controlled Trial of Idebenone in the Prevention of Episodic Migraine
Source: ClinicalTrials.gov · Last updated 15 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Idebenone improves energy metabolism similarly to Coenzyme Q10, which is effective in migraine prophylaxis. The investigators compare idebenone (90 mg/day, 270 mg/day) and placebo in 180 migraine patients in a double-blind, randomized, placebo-controlled, multicenter trial to study whether Idebenone is superior to placebo in the prevention of episodic migraine with or without aura.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 29 Oct 2019
- Start date
- 8 Dec 2021
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Migraine
- NCT number
- NCT04151472
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 180
- From 8 Dec 2021 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects previously discontinued idebenone due to adverse events.
- Subjects are taking idebenone or had taken idebenone within 14 days prior to enrollment.
Other
- Clinical diagnosis of chronic migraine.
- Subjects with continuous headaches.
Who the study is looking for
- Clinical diagnosis of episodic migraine.
- Patients (18-65 years) were eligible if they met International Headache Society (IHS) criteria for episodic migraine with/ without aura with a migraine history 1 year
- Two to eight attacks per month, 5 days/month of interval headaches.
- No over consumption of acute anti-migraine medication.
- No other prophylactic medication (washout 3 months).
- No serious organic or psychiatric disease.
- Only women with contraceptive protection.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kaiming Liu Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.