NCT00640965

DP-VPA for Migraine Prophylaxis, a Pilot Efficacy Study

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: D-Pharm Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	DP-VPA	DP-VPA dose escalation to 900mg, then continued for 8 weeks
DRUG	DP-VPA Placebo	Matching Placebo to Active, dose escalation, then continued for 8 weeks

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-06-01
• Completion: 2009-08-01
• First posted: 2008-03-21
• Last updated: 2009-05-05

Locations

6 sites across 1 country: Israel