NCT01225263

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2010

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 26, 2016

Completed
Last Updated

January 26, 2016

Status Verified

December 1, 2015

Enrollment Period

4.3 years

First QC Date

September 30, 2010

Results QC Date

December 17, 2015

Last Update Submit

December 17, 2015

Conditions

Migraine

Keywords

Migraine disordersHeadacheSimvastatinVitamin D

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Simvastatin and vitamin D

EXPERIMENTAL

Participants in this arm will receive simvastatin + vitamin D.

Drug: SimvastatinDietary Supplement: Vitamin D

Placebo "Sugar Pill"

PLACEBO COMPARATOR

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".

Other: Placebo

Interventions

SimvastatinDRUG

simvastatin, 20 mg, twice daily for 6 months

Simvastatin and vitamin D
Vitamin DDIETARY_SUPPLEMENT

Vitamin D3, 1000 IU, twice daily for 6 months

Simvastatin and vitamin D
PlaceboOTHER

Two placebo pills, taken twice daily for 6 months

Placebo "Sugar Pill"

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Buettner C, Nir RR, Bertisch SM, Bernstein C, Schain A, Mittleman MA, Burstein R. Simvastatin and vitamin D for migraine prevention: A randomized, controlled trial. Ann Neurol. 2015 Dec;78(6):970-81. doi: 10.1002/ana.24534. Epub 2015 Nov 13.

    PMID: 26418341DERIVED

MeSH Terms

Conditions

Migraine DisordersHeadache

Interventions

SimvastatinVitamin D

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsSecosteroidsSteroidsFused-Ring Compounds

Results Point of Contact

Title
Catherine Buettner, MD MPH
Organization
BIDMC
cbuettne@bidmc.harvard.edu
617-754-9600

Study Officials

  • Catherine Buettner, MD, MPH

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

  • Rami Burstein, PhD

    Beth Israel Deaconess Medical Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 30, 2010

First Posted

October 20, 2010

Study Start

September 1, 2010

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 26, 2016

Results First Posted

January 26, 2016

Record last verified: 2015-12

Locations

US(1)