DP-VPA for Migraine Prophylaxis, a Pilot Efficacy Study

May 4, 2009 updated by: D-Pharm Ltd.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Haifa, Israel
        • Bnei Zion Medical Centre
      • Holon, Israel, 58220
        • Wolfson Medical Center
      • Petah Tikva, Israel
        • Beilinson Medical Centre
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
      • Tel Hashomer, Israel, 52621
        • Chaim Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: B
Drug: DP-VPA Placebo
Matching Placebo to Active, dose escalation, then continued for 8 weeks
EXPERIMENTAL: A
DP-VPA
Drug: DP-VPA
DP-VPA dose escalation to 900mg, then continued for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Migraine attacks frequency
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Migraine days
Time Frame: 6 months
6 months
Responders (subjects with >50% decrease in migraine frequency)
Time Frame: 6 months
6 months
Triptan consumption
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

D-Pharm Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ANTICIPATED)

June 1, 2009

Study Completion (ANTICIPATED)

August 1, 2009

Study Registration Dates

First Submitted

March 17, 2008

First Submitted That Met QC Criteria

March 17, 2008

First Posted (ESTIMATE)

March 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 5, 2009

Last Update Submitted That Met QC Criteria

May 4, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ptcl-01325

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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