drugset / Trial / NCT01225263

Statin/Vitamin D & Migraine Study

NCT01225263 ↗

Phase 2 Completed 89 enrolled Rami Burstein
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2010-09
Primary completion
2015-01
Completion
2015-01

Outcome

Met primary endpoint

paper change of -9.0 (IQR: -13 to -5) days in the active group versus +3.0 (IQR: -1.0 to + 5.0) days in the placebo group, p < 0.001. PMID 26418341 ↗

paper Compared to placebo, participants using simvastatin plus vitamin D3 demonstrated a greater decrease in number of migraine days PMID 26418341 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Simvastatin Small molecule 20 mg —

Indications