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DP-VPA for Migraine Prophylaxis, a Pilot Efficacy Study
This study has been withdrawn prior to recruitment.
( STUDY WAS NOT STARTED )
Study NCT00640965   Information provided by D-Pharm Ltd.
First Received: March 17, 2008   Last Updated: May 4, 2009   History of Changes

March 17, 2008
May 4, 2009
July 2008
June 2009   (final data collection date for primary outcome measure)
Migraine attacks frequency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00640965 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
DP-VPA for Migraine Prophylaxis, a Pilot Efficacy Study
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.

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.

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Migraine
  • Drug: DP-VPA
  • Drug: DP-VPA Placebo
Experimental: DP-VPA
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Withdrawn
40
August 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00640965
Dr. Gilad Rosenberg, D-Pharm Ltd.
Ptcl-01325
D-Pharm Ltd.
 
Study Director: Gilad Rosenberg, M.D. D-Pharm Ltd.
D-Pharm Ltd.
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP