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Metformin for the Prevention of Episodic Migraine (MPEM) (MPEM)

This study is currently recruiting participants.
Verified October 2017 by Amaal J. Starling, M.D., Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT02593097
First Posted: October 30, 2015
Last Update Posted: October 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Amaal J. Starling, M.D., Mayo Clinic
  Purpose
Migraine is the third most prevalent disease in the world. Preventive treatment is indicated in about 40% of individuals with episodic migraine. Although 4 treatments are approved by the US Food and Drug Administration for prevention of episodic migraine, none were designed to prevent migraine, efficacy is modest, and all have significant adverse-event profiles. As a result, less than 1/3 of migraine sufferers with who are candidates for prevention receive drug treatment and of those who are treated, more than 85% have discontinued the preventive drug within one year. Migraine pain is associated with the activation and sensitization of specific receptors involved in pain-promoting pathways. Metformin, which is a widely available, well-tolerated anti-diabetic medication, can downregulate pain-promoting pathways. Metformin has demonstrated positive results in animal models of migraine in the laboratory. Given the longstanding use and established safety record of metformin, the investigators will evaluate the safety and efficacy of metformin for preventive treatment of migraine in a randomized, double-blind, placebo-controlled, crossover trial.

Condition Intervention Phase
Migraine Drug: Metformin Drug: Matching Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metformin for the Prevention of Episodic Migraine: a Randomized, Double-blind, Placebo-controlled, Crossover Study

Resource links provided by NLM:


Further study details as provided by Amaal J. Starling, M.D., Mayo Clinic:

Primary Outcome Measures:
  • The reduction in the number of migraine days per month during 12 weeks of treatment with metformin vs placebo (primary end point). [ Time Frame: 12 weeks ]
    To compare the reduction in the number of migraine days per month during 12 weeks of treatment with metformin vs placebo (primary end point).


Secondary Outcome Measures:
  • The response rate (percentage of patients with a >50% reduction in migraine days per month) during 12 weeks of treatment with metformin vs placebo (secondary end point). [ Time Frame: 12 weeks ]
    To compare the response rate (percentage of patients with a >50% reduction in migraine days per month) during 12 weeks of treatment with metformin vs placebo (secondary end point).

  • Number of participants with treatment-related adverse events [ Time Frame: 12 weeks ]
    Number of participants with treatment-related adverse events as assessed by the study coordinator throughout the study.


Estimated Enrollment: 40
Study Start Date: February 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin 500mg
Metformin 500mg twice a day
Drug: Metformin
Metformin 500mg twice daily
Placebo Comparator: Matching placebo
Matching placebo twice a day
Drug: Matching Placebo
Matching Placebo twice daily
Other Name: Placebo

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 previous 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593097


Contacts
Contact: Narcelle Jean-Louis 480-301-4717 JeanLouis.Narcelle@mayo.edu

Locations
United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Amaal J Starling, MD    480-301-6574    starling.amaal@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Amaal J Starling, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Amaal J. Starling, M.D., Assistant Professor, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02593097     History of Changes
Other Study ID Numbers: 15-000422
First Submitted: October 28, 2015
First Posted: October 30, 2015
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs