Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 65

Using Idebenone to prevent migraines

Official title: A Randomized, Double-blinded, Placebo-controlled Trial of Idebenone in the Prevention of Episodic Migraine

Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT04151472 · Data updated 2026-11-12

This study is testing if a new compound called idebenone can help prevent migraines in adults by seeing if it reduces the number of migraine attacks compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment180 (estimated)
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
Academic / other
Locations1 site (Hangzhou, Zhejiang)
StatusRecruiting
StartedDecember 8, 2021
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedMay 15, 2025
Trial IDNCT04151472 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 65 who experience episodic migraines with two to eight attacks per month.

Probably not a fit

Patients with chronic migraines or those who have previously experienced adverse effects from idebenone will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of idebenone, a compound that enhances energy metabolism, in preventing episodic migraines. A total of 180 participants aged 18 to 65 will be randomly assigned to receive either idebenone at doses of 90 mg or 270 mg per day, or a placebo, in a double-blind manner. The study aims to determine if idebenone is superior to placebo in reducing the frequency of migraine attacks. Participants must meet specific criteria for episodic migraine and have not used other prophylactic treatments for at least three months prior to enrollment.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency of migraine attacks for patients suffering from episodic migraines.

How similar studies have gone: Previous studies have shown that idebenone is safe and effective in other conditions, suggesting potential success in this novel application for migraine prevention.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Clinical diagnosis of episodic migraine.
2. 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
3. Two to eight attacks per month, 5 days/month of interval headaches.
4. No over consumption of acute anti-migraine medication.
5. No other prophylactic medication (washout 3 months).
6. No serious organic or psychiatric disease.
7. Only women with contraceptive protection.

Exclusion Criteria:

1. Clinical diagnosis of chronic migraine.
2. Subjects previously discontinued idebenone due to adverse events.
3. Subjects are taking idebenone or had taken idebenone within 14 days prior to enrollment.
4. Subjects with continuous headaches.

Where it's running

  • Kaiming Liu
    Hangzhou, Zhejiang, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.