Back to resultsDP-VPA for Migraine Prophylaxis, a Pilot Efficacy Study
Primary Purpose
Migraine
Status
Withdrawn
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
DP-VPA
DP-VPA Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility 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
Sites / Locations
- Rambam Medical Center
- Bnei Zion Medical Centre
- Wolfson Medical Center
- Beilinson Medical Centre
- Tel Aviv Sourasky Medical Center
- Chaim Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
DP-VPA
Outcomes
Primary Outcome Measures
Migraine attacks frequency
Secondary Outcome Measures
Migraine days
Responders (subjects with >50% decrease in migraine frequency)
Triptan consumption
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00640965
Brief Title
DP-VPA for Migraine Prophylaxis, a Pilot Efficacy Study
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 Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Withdrawn
Why Stopped
STUDY WAS NOT STARTED
Study Start Date
July 2008 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
August 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
D-Pharm Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
DP-VPA
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DP-VPA
Intervention Description
DP-VPA dose escalation to 900mg, then continued for 8 weeks
Intervention Type
Drug
Intervention Name(s)
DP-VPA Placebo
Intervention Description
Matching Placebo to Active, dose escalation, then continued for 8 weeks
Primary Outcome Measure Information:
Title
Migraine attacks frequency
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Migraine days
Time Frame
6 months
Title
Responders (subjects with >50% decrease in migraine frequency)
Time Frame
6 months
Title
Triptan consumption
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilad Rosenberg, M.D.
Organizational Affiliation
D-Pharm Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Bnei Zion Medical Centre
City
Haifa
Country
Israel
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58220
Country
Israel
Facility Name
Beilinson Medical Centre
City
Petah Tikva
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
DP-VPA for Migraine Prophylaxis, a Pilot Efficacy Study
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