Idebenone for the Preventive Treatment of Migraine

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Treatments: Idebenone; Ubiquinone

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.