Idebenone for the Preventive Treatment of Migraine
Recruiting · NCT04151472 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
270mg Idebenone90mg IdebenonePlacebo
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
1 location listed.
- Kaiming Liu - Hangzhou, Zhejiang, China