Phase 3 N=34 Randomized Quadruple-blind Treatment

Metformin for the Prevention of Episodic Migraine (MPEM)

Migraine

Bottom Line

View on ClinicalTrials.gov: NCT02593097 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2020

Primary outcome: Primary: Headache Days — 23.64; 24.33 Days — p=0.83

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Metformin (Drug); Matching Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Headache Days	23.64; 24.33	0.83
SECONDARY Greater Than >50% Reduction in Migraine Days on Metformin	10.1	0.16
SECONDARY Adverse Events	3; 1	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02593097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.