NCT05411978

Safety and Efficacy of Oral Idebenone for Preventive Treatment of Migraine in Adult Migraine Patients

A Multi-center, Randomized, Double-blind, Placebo-controlled Parallel Pilot Study to Evaluate Safety and Efficacy of Oral Idebenone for Preventive Treatment of Migraine in Adult Migraine Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a multi-center, prospective, double-blind randomized controlled trial on a sample of patients with migraine. Subjects will only be enrolled when a physician or research assistant who is familiar with the study protocol is available to enroll patients. Written, informed consent will be obtained from each patient. Consent will include a discussion of the risks and benefits.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Idebenone+ placebo	Participants will receive Idebenone 30 mg+ placebo 60 mg for 12 weeks.
DRUG	Idebenone	Participants will receive Idebenone 90 mg for 12 weeks.
DRUG	Placebo	Participants will receive Placebo 90 mg for 12 weeks

Timeline

• Start date: 2022-05-09
• Primary completion: 2024-06-20
• Completion: 2024-06-20
• First posted: 2022-06-09
• Last updated: 2022-06-23

Locations

1 site across 1 country: China