Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Phase 3
Started
2021-12-08
Last updated
2025-05-15
Condition(s) studied
Migraine DisordersHeadache Disorders
Investigational drug(s) / intervention(s)
Placebo90mg Idebenone270mg Idebenone
Placebo: Placebo oral tablet, three times a day
90mg Idebenone: Idebenone 30 MG Oral Tablet, three times a day
270mg Idebenone: Idebenone 90 MG Oral Tablet, three times a day
Study 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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
The change of migraine attack frequency — month 0, month 1, month 2, month 3, month 4 The change of migraine attack frequency in month 4 compared with baseline. Headache data (e.g., occurrence, duration, and pain severity; occurrence of photophobia, phonophobia, nausea, or vomiting; and any use of migraine medication) were captured daily through a daily headache-diary. Degree of pain and results of treatment are scored by visual analogue scale(VAS).
Trial sites (1)
Facility
City
Region
Status
Kaiming Liu
Hangzhou
Zhejiang
Recruiting
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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