A Randomized, Double-blinded, Placebo-controlled Trial of Idebenone in the Prevention of Episodic Migraine

Who is this study for? Patients with Migraine
What treatments are being studied? Idebenone
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Kaiming Liu
RECRUITING
Hangzhou
Contact Information
Primary
Kaiming Liu, MD & PHD
2314411@zju.edu.cn
+8615068862055
Time Frame
Start Date: 2021-12-08
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 180
Treatments
Experimental: 90mg Idebenone
Placebo by mouth, three times a day for 1 months； Idebenone 30mg table by mouth, three times a day for next 3 months
Experimental: 270mg Idebenone
Placebo by mouth, three times a day for 1 months； Idebenone 90mg table by mouth, three times a day for next 3 months
Placebo_comparator: Placebo
Placebo by mouth, three times a day for 4 months
Related Therapeutic Areas
Epilepsy
Migraine
Headache
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov

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