DP-VPA for Migraine Prophylaxis, a Pilot Efficacy Study

Migraine Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00640965
• Other study ID #: Ptcl-01325
• Status: Withdrawn
• Phase: Phase 2
• First received: March 17, 2008
• Last updated: May 4, 2009
• Start date: July 2008
• Est. completion date: August 2009

Study information

• Verified date: May 2009
• Source: D-Pharm Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Health Ministry, Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 40
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• DP-VPA
DP-VPA dose escalation to 900mg, then continued for 8 weeks
• DP-VPA Placebo
Matching Placebo to Active, dose escalation, then continued for 8 weeks

Locations

Country	Name	City	State
Israel	Bnei Zion Medical Centre	Haifa
Israel	Rambam Medical Center	Haifa
Israel	Wolfson Medical Center	Holon
Israel	Beilinson Medical Centre	Petah Tikva
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	Chaim Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
D-Pharm Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraine attacks frequency		6 months	No
Secondary	Migraine days		6 months	No
Secondary	Responders (subjects with >50% decrease in migraine frequency)		6 months	No
Secondary	Triptan consumption		6 months	No