Metformin for the Prevention of Episodic Migraine (MPEM) (MPEM)
Primary Purpose
Migraine
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Metformin
Matching Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility Criteria
Inclusion Criteria:
- age 18-65 years
- a diagnosis of migraine with or without aura for >1 year according to the International Classification of Headache Disorders-IIIb
Exclusion Criteria:
- a diagnosis of diabetes mellitus or polycystic ovarian syndrome
- overuse of acute migraine treatments
- failure to respond to 3 or more classes of preventive drug treatments
- change in dose of migraine-preventive medication within 2 months of beginning the baseline diary phase
- significant somatic or psychiatric disease
- known alcohol or other substance abuse
- pregnant or breastfeeding.
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Metformin first, then matching placebo
Matching placebo first, then Metformin
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Headache Days
Total number of moderate and severe headache days
Secondary Outcome Measures
Greater Than >50% Reduction in Migraine Days on Metformin
Percentage of patients whose migraines reduced by at least 50% on Metformin.
Adverse Events
Total number of subjects with treatment-related adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02593097
Brief Title
Metformin for the Prevention of Episodic Migraine (MPEM)
Acronym
MPEM
Official Title
Metformin for the Prevention of Episodic Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin first, then matching placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Matching placebo first, then Metformin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin 500mg twice daily
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Other Intervention Name(s)
Placebo
Intervention Description
Matching Placebo twice daily
Primary Outcome Measure Information:
Title
Headache Days
Description
Total number of moderate and severe headache days
Time Frame
Baseline through end of study for a total of approximately 32 weeks
Secondary Outcome Measure Information:
Title
Greater Than >50% Reduction in Migraine Days on Metformin
Description
Percentage of patients whose migraines reduced by at least 50% on Metformin.
Time Frame
12 weeks
Title
Adverse Events
Description
Total number of subjects with treatment-related adverse events
Time Frame
Baseline through end of study for a total of approximately 32 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18-65 years
a diagnosis of migraine with or without aura for >1 year according to the International Classification of Headache Disorders-IIIb
Exclusion Criteria:
a diagnosis of diabetes mellitus or polycystic ovarian syndrome
overuse of acute migraine treatments
failure to respond to 3 or more classes of preventive drug treatments
change in dose of migraine-preventive medication within 2 months of beginning the baseline diary phase
significant somatic or psychiatric disease
known alcohol or other substance abuse
pregnant or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amaal J Starling, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23831352
Citation
Price TJ, Dussor G. AMPK: An emerging target for modification of injury-induced pain plasticity. Neurosci Lett. 2013 Dec 17;557 Pt A(0 0):9-18. doi: 10.1016/j.neulet.2013.06.060. Epub 2013 Jul 3.
Results Reference
background
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Metformin for the Prevention of Episodic Migraine (MPEM)
We'll reach out to this number within 24 hrs