Metformin for the Prevention of Episodic Migraine (MPEM)

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators will evaluate the safety and efficacy of metformin for preventive treatment of migraine in a randomized, double-blind, placebo-controlled, crossover trial.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. age 18-65 years

2. a diagnosis of migraine with or without aura for >1 year according to the International Classification of Headache Disorders-IIIb

Exclusion Criteria:

1. a diagnosis of diabetes mellitus or polycystic ovarian syndrome

2. overuse of acute migraine treatments

3. failure to respond to 3 or more classes of preventive drug treatments

4. change in dose of migraine-preventive medication within 2 months of beginning the baseline diary phase

5. significant somatic or psychiatric disease

6. known alcohol or other substance abuse

7. pregnant or breastfeeding.