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

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ClinicalTrials.gov Identifier: NCT02593097
Recruitment Status : Active, not recruiting
First Posted : October 30, 2015
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Amaal J. Starling, M.D., Mayo Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Migraine Drug: Metformin Drug: Matching Placebo Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : February 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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).

  2. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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 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.

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


Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Amaal J Starling, MD Mayo Clinic

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 Posted: October 30, 2015    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
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