Trial Outcomes & Findings for Statin/Vitamin D & Migraine Study (NCT NCT01225263)
NCT ID: NCT01225263
Last Updated: 2016-01-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
89 participants
Primary outcome timeframe
Weeks 1 to 12
Results posted on
2016-01-26
Participant Flow
Participants were recruited from the greater Boston area. All study visits took place at Beth Israel Deaconess Medical Center (Boston, MA).
Of 89 participants enrolled, 32 were excluded prior to randomization: 8 not interested; 8 lost to follow up; 7 had \<4 migraine days/mo; 4 had chronic daily headache; 2 daily opioid use; 1 chronic pain; 1 using a statin; 1 using a medication contraindicated with statin. The remaining 57 participants completed a 12-wk baseline and were randomized.
Participant milestones
| Measure |
Simvastatin and Vitamin D
Participants in this arm took Simvastatin 20 mg twice daily for 6 months plus Vitamin D3 1000 IU twice daily for 6 months.
|
Placebo "Sugar Pill"
Participants in this arm took placebo pills, which looked like the Simvastatin and Vitamin D. Two placebo pills were taken twice daily for 6 months.
|
|---|---|---|
|
Weeks 1 to 12
STARTED
|
28
|
29
|
|
Weeks 1 to 12
COMPLETED
|
28
|
29
|
|
Weeks 1 to 12
NOT COMPLETED
|
0
|
0
|
|
Weeks 13 to 24
STARTED
|
28
|
29
|
|
Weeks 13 to 24
COMPLETED
|
24
|
28
|
|
Weeks 13 to 24
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Statin/Vitamin D & Migraine Study
Baseline characteristics by cohort
| Measure |
Simvastatin and Vitamin D
n=28 Participants
Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
|
Placebo
n=29 Participants
Participants in this arm received placebo pills, which looked like the Simvastatin pill and Vitamin D pill. Two placebo pills were taken twice daily for 6 months
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
40 years
n=93 Participants
|
28 years
n=4 Participants
|
33 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
24 participants
n=93 Participants
|
21 participants
n=4 Participants
|
45 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=93 Participants
|
8 participants
n=4 Participants
|
12 participants
n=27 Participants
|
|
Recorded Migraine Days/Past 3m, Median (Interquartile Range)
|
25.5 days
n=93 Participants
|
18.0 days
n=4 Participants
|
20 days
n=27 Participants
|
PRIMARY outcome
Timeframe: Weeks 1 to 12Outcome measures
| Measure |
Simvastatin and Vitamin D
n=28 Participants
Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
|
Placebo
n=29 Participants
Participants in this arm received placebo pills, which looked like the simvastatin and Vitamin D pills, taken twice daily for 6 months
|
|---|---|---|
|
Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12
|
-8.0 days
Interval -15.0 to -2.0
|
1.0 days
Interval -1.0 to 6.0
|
PRIMARY outcome
Timeframe: Weeks 13 to 24Outcome measures
| Measure |
Simvastatin and Vitamin D
n=28 Participants
Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
|
Placebo
n=29 Participants
Participants in this arm received placebo pills, which looked like the simvastatin and Vitamin D pills, taken twice daily for 6 months
|
|---|---|---|
|
Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24
|
-9.0 days
Interval -13.0 to -5.0
|
3.0 days
Interval -1.0 to 5.0
|
Adverse Events
Simvastatin and Vitamin D
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Simvastatin and Vitamin D
n=28 participants at risk
Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
|
Placebo
n=29 participants at risk
Participants in this arm received placebo pills, which looked like the simvastatin and Vitamin D pills, taken twice daily for 6 months
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/28
|
3.4%
1/29 • Number of events 1
|
Other adverse events
| Measure |
Simvastatin and Vitamin D
n=28 participants at risk
Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
|
Placebo
n=29 participants at risk
Participants in this arm received placebo pills, which looked like the simvastatin and Vitamin D pills, taken twice daily for 6 months
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/28
|
6.9%
2/29 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
3.6%
1/28 • Number of events 1
|
10.3%
3/29 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia (without CK elevation)
|
3.6%
1/28 • Number of events 1
|
10.3%
3/29 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin rash or itch
|
10.7%
3/28 • Number of events 3
|
6.9%
2/29 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place