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DP-VPA for Migraine Prophylaxis, a Pilot Efficacy Study

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ClinicalTrials.gov Identifier: NCT00640965
Recruitment Status : Withdrawn (STUDY WAS NOT STARTED)
First Posted : March 21, 2008
Last Update Posted : May 5, 2009
Sponsor:
Information provided by:
D-Pharm Ltd.

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 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 or disease Intervention/treatment Phase
Migraine Drug: DP-VPA Drug: DP-VPA Placebo Phase 2

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2008
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Migraine attacks frequency [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Migraine days [ Time Frame: 6 months ]
  2. Responders (subjects with >50% decrease in migraine frequency) [ Time Frame: 6 months ]
  3. Triptan consumption [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640965


Locations
Israel
Rambam Medical Center
Haifa, Israel, 31096
Bnei Zion Medical Centre
Haifa, Israel
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.

Responsible Party: Dr. Gilad Rosenberg, D-Pharm Ltd.
ClinicalTrials.gov Identifier: NCT00640965     History of Changes
Other Study ID Numbers: Ptcl-01325
First Posted: March 21, 2008    Key Record Dates
Last Update Posted: May 5, 2009
Last Verified: May 2009

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