MigrainePhase 2NCT01225263
Statin/Vitamin D & Migraine Study
A Phase 2 study testing Simvastatin and Vitamin D in people with Migraine, run by Rami Burstein at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Simvastatin and Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jan 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Combined Statin and Vitamin D Therapy for Prophylactic Treatment of Episodic Migraine
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.
- Conditions
- Migraine
- Being tested
- Simvastatin, Vitamin D, Placebo
- Keywords
- Migraine disorders, Headache, Simvastatin, Vitamin D
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
simvastatin, 20 mg, twice daily for 6 months
Vitamin DDietary supplement
Vitamin D3, 1000 IU, twice daily for 6 months
PlaceboOther
Two placebo pills, taken twice daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin and vitamin D | Experimental | Participants in this arm will receive simvastatin + vitamin D. Receives: Drug: Simvastatin; Dietary 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". Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12
Measured: Weeks 1 to 12
Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24
Measured: Weeks 13 to 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rami Burstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rami Burstein, Beth Israel Deaconess Medical Center
- Investigators
- Catherine Buettner, MD, MPH, Principal investigator, Beth Israel Deaconess Medical CenterRami Burstein, PhD, Study director, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225263
- Sponsor's protocol ID
- 2010P000118
- Status last verified
- Dec 2015
- First submitted
- 30 Sep 2010
- Last updated
- 26 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26418341
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Statin and Vitamin D Therapy for Prophylactic Treatment of Episodic Migraine
- ClinicalTrials.gov ID
- NCT01225263
- Acronym / sponsor ID
- 2010P000118
- Conditions
- Migraine
- Keywords
- Migraine disorders, Headache, Simvastatin, Vitamin D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Rami BursteinUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Posted 26 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin and vitamin D | Experimental | Drug: Simvastatin, Dietary Supplement: Vitamin DParticipants in this arm will receive simvastatin + vitamin D. |
| Placebo "Sugar Pill" | Placebo comparator | Other: PlaceboParticipants 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". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simvastatinsimvastatin, 20 mg, twice daily for 6 months | Drug | Simvastatin and vitamin D |
| Vitamin DVitamin D3, 1000 IU, twice daily for 6 months | Dietary supplement | Simvastatin and vitamin D |
| PlaceboTwo placebo pills, taken twice daily for 6 months | Other | Placebo "Sugar Pill" |
Primary outcome
Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12
Time frame: Weeks 1 to 12
Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24
Time frame: Weeks 13 to 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26418341Buettner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Buettner, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
Rami Burstein, PhD study director
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simvastatin and Vitamin D in people with Migraine, run by Rami Burstein at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12 (time frame: Weeks 1 to 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01225263, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.