Metformin for the Prevention of Episodic Migraine (MPEM)
MPEM
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2016
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2015
CompletedFirst Posted
Study publicly available on registry
October 30, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedResults Posted
Study results publicly available
July 1, 2020
CompletedJuly 1, 2020
June 1, 2020
3.3 years
October 28, 2015
May 22, 2020
June 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Headache Days
Total number of moderate and severe headache days
Baseline through end of study for a total of approximately 32 weeks
Secondary Outcomes (2)
Greater Than >50% Reduction in Migraine Days on Metformin
12 weeks
Adverse Events
Baseline through end of study for a total of approximately 32 weeks
Study Arms (2)
Metformin first, then matching placebo
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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.
Interventions
Metformin 500mg twice daily
Matching Placebo twice daily
Eligibility Criteria
You may qualify if:
- age 18-65 years
- a diagnosis of migraine with or without aura for \>1 year according to the International Classification of Headache Disorders-IIIb
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Related 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(0 0):9-18. doi: 10.1016/j.neulet.2013.06.060. Epub 2013 Jul 3.
PMID: 23831352BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Amaal J. Starling, M.D.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Amaal J Starling, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 28, 2015
First Posted
October 30, 2015
Study Start
February 1, 2016
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
July 1, 2020
Results First Posted
July 1, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share