Phase 2 N=57 Randomized Triple-blind Prevention

Statin/Vitamin D & Migraine Study

Migraine

Bottom Line

View on ClinicalTrials.gov: NCT01225263 ↗

Enrolled (actual)

Serious AEs

1.8%

Results posted

Jan 2016

Primary outcome: Primary: Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12 — -8.0; 1.0 days

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Simvastatin (Drug); Vitamin D (Dietary_supplement); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Rami Burstein
Primary completion: Jan 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12	-8.0; 1.0	—
PRIMARY Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24	-9.0; 3.0	—

Summary

The investigators are studying if taking simvastatin and vitamin D together will help prevent episodic migraines. Simvastatin is an FDA approved drug that is typically used to treat high cholesterol and reduce the risk of stroke and heart attack. Vitamin D is a vitamin found in certain foods like some types of fish, and in nutritional supplements. This study is 9 months long. Some people who participate will receive simvastatin and vitamin D, and some people will receive a placebo. A placebo is a "sugar pill" that looks like medication but does not have any active ingredients in it. The investigators hypothesize that taking vitamin D and simvastatin daily may reduce the number of migraines people who have episodic migraine get.

Eligibility Criteria

Inclusion Criteria

Age 18 years or older
Have had migraines for at least 3 years
Have between 4 and 15 migraines a month
Able to speak and read the English language

Exclusion Criteria

Women who are pregnant or nursing, or planning on becoming pregnant in the next 10 months
Individuals who have a had a heart attack, stroke, peripheral artery disease, atherosclerotic aortic disease, carotid artery disease, or diabetes
individuals at high risk for cardiovascular disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01225263). 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.