Idebenone for the Preventive Treatment of Migraine

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Migraine Disorders, Headache Disorders

In brief

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.

Key facts

Study ID

NCT04151472

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

180

Starts

2021-12-08

Expected to finish

2025-12-31

Last updated by the study team

2025-05-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Kaiming Liu — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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