Idebenone for the Preventive Treatment of Migraine
Recruiting
Phase 3
Interventional Study
Migraine Disorders
Headache Disorders
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 180 (estimated)
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine · Other
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About This Trial
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.
Trial Locations
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Eligibility 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 heada…
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