Idebenone for the Preventive Treatment of Migraine
A Randomized, Double-blinded, Placebo-controlled Trial of Idebenone in the Prevention of Episodic Migraine
Second Affiliated Hospital, School of Medicine, Zhejiang University
180 participants
Dec 8, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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.
Exclusion Criteria4
- 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.
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Interventions
Placebo oral tablet, three times a day
Idebenone 30 MG Oral Tablet, three times a day
Idebenone 90 MG Oral Tablet, three times a day
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04151472