The study will evaluate if DP-VPA, a derivative of valproate (a drug that is commonly used for the prevention of migraine attacks), can reduce the rate of migraine attacks.
Migraine patients will take DP-VPA or placebo (an inactive look-alike drug) every morning and will have to report any migraine attacks they have during the study's 18-week follow up.
| Study Type: |
Interventional |
| Study Design: |
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: |
Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Two-Arm, Multi-Center Phase II Trial to Assess the Safety, Tolerability, and Efficacy of DP-VPA (up to 900 mg) Once Daily for 10 Weeks in Adult Subjects With Migraine |
Primary Outcome Measures:
- Migraine attacks frequency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Migraine days [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Responders (subjects with >50% decrease in migraine frequency) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Triptan consumption [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: |
40 |
| Study Start Date: |
July 2008 |
| Estimated Study Completion Date: |
August 2009 |
| Estimated Primary Completion Date: |
June 2009 (Final data collection date for primary outcome measure) |
|
A: Experimental
DP-VPA
|
Drug: DP-VPA
DP-VPA dose escalation to 900mg, then continued for 8 weeks
|
|
B: Placebo Comparator
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Drug: DP-VPA Placebo
Matching Placebo to Active, dose escalation, then continued for 8 weeks
|
The multi-center trial has a double-blind, randomized, placebo-controlled, parallel-group design and will be carried out in Israel. Approximately 40 adult subjects with migraine will be randomly assigned (1:1) to either DP-VPA (maximum of 900mg/day) or placebo. Active and placebo will be administered orally and once-daily on an add-on basis, i.e. other permissible ongoing medications will be continued. Total study duration per subject will be 18 weeks. Subjects will report on their migraine attacks frequency and other attack characteristics using weekly diaries.
Purpose
