Statin/Vitamin D & Migraine Study

Phase 2

Completed

• Conditions: Migraine
• Interventions: Drug: Simvastatin; Other: Placebo; Dietary Supplement: Vitamin D

• Registration Number: NCT01225263
• Lead Sponsor: Rami Burstein

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-30
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-12
• Results First Submitted: 2015-12-17
• Results First Submitted QC: 2015-12-17
• Last Update Submitted: 2015-12-17
• Results First Posted: 2016-01-26
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simvastatin and vitamin D	Simvastatin	Participants in this arm will receive simvastatin + vitamin D.
Simvastatin and vitamin D	Vitamin D	Participants in this arm will receive simvastatin + vitamin D.
Placebo "Sugar Pill"	Placebo	Participants in this arm will take placebo pills, which look like the simvastatin and vitamin D. A placebo pill has no active medication in it, and is like taking a "sugar pill".

Primary Outcome Measures

Name	Time	Method
Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12	Weeks 1 to 12
Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24	Weeks 13 to 24

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States