DP-VPA for Migraine Prophylaxis, a Pilot Efficacy Study
- Registration Number
- NCT00640965
- Lead Sponsor
- D-Pharm Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A DP-VPA DP-VPA B DP-VPA Placebo -
- Primary Outcome Measures
Name Time Method Migraine attacks frequency 6 months
- Secondary Outcome Measures
Name Time Method Migraine days 6 months Responders (subjects with >50% decrease in migraine frequency) 6 months Triptan consumption 6 months
Trial Locations
- Locations (6)
Bnei Zion Medical Centre
🇮🇱Haifa, Israel
Chaim Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Wolfson Medical Center
🇮🇱Holon, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Beilinson Medical Centre
🇮🇱Petah Tikva, Israel
Rambam Medical Center
🇮🇱Haifa, Israel