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New treatment option for Migraine Disorders
Official title Idebenone for the Preventive Treatment of Migraine
ClinicalTrials.gov ID: NCT04151472
What this study is testing
What is 90mg Idebenone?
90mg Idebenone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for migraine disorders.
Also referred to as Shenwei.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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).
You likely can't join if
- Clinical diagnosis of chronic migraine.
- people previously discontinued idebenone due to adverse events.
- people are taking idebenone or had taken idebenone within 14 days prior to enrollment.
- people with continuous headaches.
See the full eligibility criteria
- 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.
- Clinical diagnosis of chronic migraine.
- people previously discontinued idebenone due to adverse events.
- people are taking idebenone or had taken idebenone within 14 days prior to enrollment.
- people with continuous headaches.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.