Idebenone for the Preventive Treatment of Migraine

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Nov 2, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Idebenone to see if it can help prevent migraines. Researchers want to find out if taking Idebenone in two different doses (90 mg and 270 mg per day) is more effective than a placebo (a pill that doesn’t contain any active medication) for people who experience episodic migraines, which means having migraine attacks a few times a month. The trial is open to adults aged 18 to 65 who have a history of migraines and meet specific criteria, such as having between two to eight migraine attacks each month.

Participants in the study will be randomly assigned to receive either Idebenone or a placebo, and neither they nor the researchers will know which one they are taking, which helps ensure fair results. To be eligible, participants should not have chronic migraines or serious health conditions and must not be taking other migraine medications. Women who join the study need to use contraceptive methods. This trial is currently recruiting participants, and those who take part will help researchers understand if Idebenone can be a helpful option for preventing migraines.

Gender

ALL

Eligibility criteria

• 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.