Metformin for the Prevention of Episodic Migraine (MPEM)

Phase 3

Completed

• Conditions: Migraine
• Interventions: Drug: Metformin; Drug: Matching Placebo

• Registration Number: NCT02593097
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

This will be a single-center, double-blind, randomized, placebo-controlled, crossover study. The investigators will enroll 40 subjects. Subjects will be recruited from the outpatient Mayo Headache Clinic, Mayo Women's Health Clinic, Mayo Community Internal Medicine, and the Mayo Clinic- Arizona State University Neurology Clinic. The Headache Clinic employs 6 headache specialists and 1 fellow which is sufficient staffing to support this study and recruitment of patients with migraine.

Before study enrollment, patients will undergo a 2-hour oral glucose tolerance test to confirm the absence of diabetes mellitus.

Subjects will then keep a headache diary for 4 weeks to establish baseline characteristics, including number of migraine days per month, number of moderate to severe headache days per month, and number of days per month of acute medication use. The 4-week baseline period will be followed by 2 treatment periods of 12 weeks each, separated by a washout period of 4 weeks (total study duration, 32 weeks). For the 12-week treatment periods, subjects will receive either metformin 500mg twice daily or matching placebo twice daily.

Subjects will have 7 study visits. Routine laboratory studies and a pregnancy test will be performed at enrollment and week 20. Abnormal kidney or liver function will exclude subjects. Pregnancy will exclude subjects. General and neurologic examinations will be performed during 3 of the 7 visits. At each visit, subjects will receive medication for the period until the next visit. A headache diary will be used for the trial. For every day that the subject has a headache of any type, she or he will record headache characteristics, associated features, and medications used.

Study Timeline

• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Study Start: 2016-02
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Results First Submitted: 2020-05-22
• Status Verified: 2020-06
• Results First Submitted QC: 2020-06-15
• Last Update Submitted: 2020-06-15
• Results First Posted: 2020-07-01
• Last Update Posted: 2020-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Matching placebo first, then Metformin	Matching Placebo	Subjects will be randomized into the matching placebo group, treated for 12 weeks with a 4 week washout period in between treatments, then treated with Metformin for 12 weeks.
Metformin first, then matching placebo	Matching Placebo	Subjects will be randomized into the Metformin group, treated for 12 weeks with a 4 week washout period in between treatments, then treated with matching placebo for 12 weeks.
Matching placebo first, then Metformin	Metformin	Subjects will be randomized into the matching placebo group, treated for 12 weeks with a 4 week washout period in between treatments, then treated with Metformin for 12 weeks.
Metformin first, then matching placebo	Metformin	Subjects will be randomized into the Metformin group, treated for 12 weeks with a 4 week washout period in between treatments, then treated with matching placebo for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Headache Days	Baseline through end of study for a total of approximately 32 weeks	Total number of moderate and severe headache days

Secondary Outcome Measures

Name	Time	Method
Greater Than >50% Reduction in Migraine Days on Metformin	12 weeks	Percentage of patients whose migraines reduced by at least 50% on Metformin.
Adverse Events	Baseline through end of study for a total of approximately 32 weeks	Total number of subjects with treatment-related adverse events

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States