A Phase 3 interventional study of Metformin and Matching Placebo in Migraine, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-01.
Sponsored by Mayo Clinic · Phase 3, Interventional, and Treatment
The investigators will evaluate the safety and efficacy of metformin for preventive treatment of migraine in a randomized, double-blind, placebo-controlled, crossover trial.
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 34 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Exclusion Criteria:
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.
Drug: Metformin · Drug: Matching Placebo
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.
Drug: Metformin · Drug: Matching Placebo
Metformin 500mg twice daily
Matching Placebo twice daily
Also known as: Placebo
Headache Days
Total number of moderate and severe headache days
Time frame: Baseline through end of study for a total of approximately 32 weeks
Greater Than >50% Reduction in Migraine Days on Metformin
Percentage of patients whose migraines reduced by at least 50% on Metformin.
Time frame: 12 weeks
Adverse Events
Total number of subjects with treatment-related adverse events
Time frame: Baseline through end of study for a total of approximately 32 weeks
| Milestone | Metformin First, Then Matching Placebo | Matching Placebo First, Then Metformin |
|---|---|---|
| Started | 14 | 20 |
| Received intervention | 14 | 20 |
| Completed | 12 | 16 |
| Not completed | 2 | 4 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Milestone | Metformin First, Then Matching Placebo | Matching Placebo First, Then Metformin |
|---|---|---|
| Started | 12 | 16 |
| Completed | 12 | 16 |
| Not completed | 0 | 0 |
| Milestone | Metformin First, Then Matching Placebo | Matching Placebo First, Then Metformin |
|---|---|---|
| Started | 12 | 16 |
| Completed | 9 | 15 |
| Not completed | 3 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Total number of moderate and severe headache days
| Days | Metformin | Matching Placebo |
|---|---|---|
| Headache Days | 23.64 ± 2.15 | 24.33 ± 2.19 |
Percentage of patients whose migraines reduced by at least 50% on Metformin.
| percentage of subjects | Metformin | Matching Placebo |
|---|---|---|
| Greater Than >50% Reduction in Migraine Days on Metformin | 10.1 (-3.46 to 23.66) | — |
Total number of subjects with treatment-related adverse events
| Participants | Metformin | Matching Placebo |
|---|---|---|
| Adverse Events | 3 | 1 |
Collected over Adverse Events were collected from a period of baseline to four weeks post last intervention for a total of approximately 32 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Metformin | 0/30 (0%) | 0/30 (0%) | 12/30 (40%) |
| Matching Placebo | 0/32 (0%) | 0/32 (0%) | 4/32 (12.5%) |
| Event | Metformin | Matching Placebo |
|---|---|---|
| Dry MouthRespiratory, thoracic and mediastinal disorders | 3/30 | 1/32 |
| DiarrheaGastrointestinal disorders | 3/30 | 1/32 |
| Dry hairSkin and subcutaneous tissue disorders | 3/30 | 1/32 |
| Hair lossSkin and subcutaneous tissue disorders | 3/30 | 1/32 |
| Age, Continuous(years) | Metformin First, Then Matching Placebo | Matching Placebo First, Then Metformin | Total |
|---|---|---|---|
| Mean | 43.85 ± 6.91 | 46.83 ± 10.94 | 45.34 ± 8.92 |
| Sex: Female, Male(Participants) | Metformin First, Then Matching Placebo | Matching Placebo First, Then Metformin | Total |
|---|---|---|---|
| Female | 11 | 17 | 28 |
| Male | 3 | 3 | 6 |
| Race and Ethnicity Not Collected(Participants) | Metformin First, Then Matching Placebo | Matching Placebo First, Then Metformin | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Metformin First, Then Matching Placebo | Matching Placebo First, Then Metformin | Total |
|---|---|---|---|
| United States | 14 | 20 | 34 |
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