Using Idebenone to prevent migraines
A Randomized, Double-blinded, Placebo-controlled Trial of Idebenone in the Prevention of Episodic Migraine
PHASE3 · Second Affiliated Hospital, School of Medicine, Zhejiang University · NCT04151472
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
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT04151472 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who experience episodic migraines with two to eight attacks per month.
Not a fit: Patients with chronic migraines or those who have previously experienced adverse effects from idebenone will not benefit from this study.
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 performed: Previous studies have shown that idebenone is safe and effective in other conditions, suggesting potential success in this novel application for migraine prevention.
Eligibility criteria
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 this trial is running
Hangzhou, Zhejiang
- Kaiming Liu — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Kaiming Liu, MD & PHD
- Email: 2314411@zju.edu.cn
- Phone: +8615068862055
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Migraine Disorders, Headache Disorders, Migraine Prophylaxis, Mitochondrial Dysfunction, Idebenone, Individualized Treatment