Metformin for the Prevention of Episodic Migraine (MPEM)

Migraine Clinical Trial

— MPEM  

Official title:

Metformin for the Prevention of Episodic Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593097
• Other study ID #: 15-000422
• Status: Completed
• Phase: Phase 3
• Start date: February 2016
• Est. completion date: June 2019

Study information

• Verified date: June 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Metformin
Metformin 500mg twice daily
• Matching Placebo
Matching Placebo twice daily

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Price TJ, Dussor G. AMPK: An emerging target for modification of injury-induced pain plasticity. Neurosci Lett. 2013 Dec 17;557 Pt A:9-18. doi: 10.1016/j.neulet.2013.06.060. Epub 2013 Jul 3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Days	Total number of moderate and severe headache days	Baseline through end of study for a total of approximately 32 weeks
Secondary	Greater Than >50% Reduction in Migraine Days on Metformin	Percentage of patients whose migraines reduced by at least 50% on Metformin.	12 weeks
Secondary	Adverse Events	Total number of subjects with treatment-related adverse events	Baseline through end of study for a total of approximately 32 weeks

External Links

•   Mayo Clinic Clinical Trials