A Phase 3 Study Comparing Idebenone Doses to Placebo for Preventing Episodic Migraine in Adults

What this Trial Is About

Researchers are evaluating idebenone, a drug that may improve energy metabolism like Coenzyme Q10, for preventing episodic migraines with or without aura. This study compares two doses of idebenone 90 mgday and 270 mgday against a placebo in 180 adults aged 18 to 65 who experience two to eight migraine attacks per month. The trial follows strict guidelines and aims to find out if idebenone can reduce migraine frequency and improve quality of life for migraine sufferers. Participants first receive a placebo for one month to establish a baseline. Then they are randomly assigned to three groups one takes 90 mgday idebenone, another 270 mgday idebenone, and the third continues with placebo for the next three months. The study is double-blind, meaning neither the participants nor the researchers know who is receiving which treatment. All medication is taken orally three times a day. Throughout the study, participants will track migraine days, attack frequency, headache severity, and medication use. Researchers will assess quality of life and migraine-related disability using questionnaires. Safety is monitored by interviewing patients about any adverse events at each visit. The main goal is to measure the change in migraine attack frequency over the study period, with additional outcomes including headache days and migraine severity. The study ends after four months of treatment and follow-up.

Idebenone for the Preventive Treatment of Migraine