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

NCT05411978 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2022-06-23

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-09
Primary Completion
2024-06-20
Completion
2024-06-20

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05411978 on ClinicalTrials.gov