Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
D-Pharm Ltd. |
---|---|
Information provided by: | D-Pharm Ltd. |
ClinicalTrials.gov Identifier: | NCT00640965 |
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.
Condition | Intervention | Phase |
---|---|---|
Migraine |
Drug: DP-VPA Drug: DP-VPA Placebo |
Phase II |
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 |
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) |
Arms | Assigned Interventions |
---|---|
A: Experimental
DP-VPA
|
Drug: DP-VPA
DP-VPA dose escalation to 900mg, then continued for 8 weeks
|
B: Placebo Comparator |
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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria (abridged)
Exclusion criteria (abridged)Chronic migraine (>15 days of migraine/ month).
Israel | |
Chaim Sheba Medical Center | |
Tel Hashomer, Israel, 52621 | |
Rambam Medical Center | |
Haifa, Israel, 31096 | |
Tel Aviv Sourasky Medical Center | |
Tel Aviv, Israel, 64239 | |
Beilinson Medical Centre | |
Petah Tikva, Israel | |
Bnei Zion Medical Centre | |
Haifa, Israel | |
Wolfson Medical Center | |
Holon, Israel, 58220 |
Study Director: | Gilad Rosenberg, M.D. | D-Pharm Ltd. |
Responsible Party: | D-Pharm Ltd. ( Dr. Gilad Rosenberg ) |
Study ID Numbers: | Ptcl-01325 |
Study First Received: | March 17, 2008 |
Last Updated: | May 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00640965 History of Changes |
Health Authority: | Israel: Health Ministry, Pharmaceutical Administration |
Migraine Disorders Headache Central Nervous System Diseases |
Headache Disorders, Primary Brain Diseases Headache Disorders |
Migraine Disorders Nervous System Diseases Central Nervous System Diseases |
Headache Disorders, Primary Brain Diseases Headache Disorders |