Status:
WITHDRAWN
DP-VPA for Migraine Prophylaxis, a Pilot Efficacy Study
Lead Sponsor:
D-Pharm Ltd.
Conditions:
Migraine
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 tak...
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 assig...
Eligibility Criteria
Inclusion
- Inclusion criteria (abridged)
- Male and female subjects with migraine with or without aura fulfilling the diagnostic criteria of the International Classification of Headache Disorders
- 3 to 6 migraine attacks per month
- Concomitant prophylactic migraine treatment with a beta-blocker or amitriptyline that has been stable in the proceeding 3 months. No changes in this concomitant treatment will be allowed until the end of study follow-up.
- Exclusion criteria (abridged)Chronic migraine (\>15 days of migraine/ month).
- Migraine complicated by medication-overuse headache.
- Allergy or hypersensitivity to valproic acid, valproate sodium, or soy.
- Known contraindications to valproic acid.
- Pregnancy.
- Breastfeeding female subjects.
- Subjects with significant hepatic dysfunction indicated by SGOT or SGPT \>3 times the upper limit of normal at screening.
- Renal impairment indicated by serum creatinine \>1.5mg/dL at screening.
- Potentially fertile and sexually active women who do not practice reliable contraception.
- Men who do not practice reliable barrier contraception.
- Concomitant use of antipsychotic, antidepressant or antiepileptic therapy - with the exception of amitriptyline - within 1 month of screening, or a medical condition that is likely to require such treatment during the trial participation.
- An active central nervous system disease deemed to be unstable or progressive during the course of the study that may confound the interpretation of the study results.
- Any medical disorder that may makes the subject unlikely to fully complete the study- Blood coagulation disorder.
- Concomitant drugs known to interact with VPA.- Alcohol or other drugs abuse.
- Therapy with another investigational product within 30 days prior start of study.
- Concomitant participation in another trial or study
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00640965
Start Date
July 1 2008
End Date
August 1 2009
Last Update
May 5 2009
Active Locations (6)
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1
Rambam Medical Center
Haifa, Israel, 31096
2
Bnei Zion Medical Centre
Haifa, Israel
3
Wolfson Medical Center
Holon, Israel, 58220
4
Beilinson Medical Centre
Petah Tikva, Israel