DP-VPA for Migraine Prophylaxis, a Pilot Efficacy Study

This study has been withdrawn prior to enrollment.
(STUDY WAS NOT STARTED)
Sponsor:
Information provided by:
D-Pharm Ltd.
ClinicalTrials.gov Identifier:
NCT00640965
First received: March 17, 2008
Last updated: May 4, 2009
Last verified: May 2009
  Purpose

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 2

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

Resource links provided by NLM:


Further study details as provided by D-Pharm Ltd.:

Primary Outcome Measures:
  • Migraine attacks frequency [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Migraine days [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Responders (subjects with >50% decrease in migraine frequency) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Triptan consumption [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
Experimental: A
DP-VPA
Drug: DP-VPA
DP-VPA dose escalation to 900mg, then continued for 8 weeks
Placebo Comparator: B Drug: DP-VPA Placebo
Matching Placebo to Active, dose escalation, then continued for 8 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640965

Locations
Israel
Bnei Zion Medical Centre
Haifa, Israel
Rambam Medical Center
Haifa, Israel, 31096
Wolfson Medical Center
Holon, Israel, 58220
Beilinson Medical Centre
Petah Tikva, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
D-Pharm Ltd.
Investigators
Study Director: Gilad Rosenberg, M.D. D-Pharm Ltd.
  More Information

No publications provided

Responsible Party: Dr. Gilad Rosenberg, D-Pharm Ltd.
ClinicalTrials.gov Identifier: NCT00640965     History of Changes
Other Study ID Numbers: Ptcl-01325
Study First Received: March 17, 2008
Last Updated: May 4, 2009
Health Authority: Israel: Health Ministry, Pharmaceutical Administration

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014