DP-VPA for Migraine Prophylaxis, a Pilot Efficacy Study

• Status: Withdrawn
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: D-Pharm Ltd.

Criteria

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