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| Descriptive Information Fields | |||||
| 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 | ||||
| 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. |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Migraine attacks frequency [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | 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 ] |
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| Condition † | Migraine | ||||
| Intervention † | Drug: DP-VPA Drug: DP-VPA Placebo |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Not yet recruiting | ||||
| Enrollment † | 40 | ||||
| Start Date † | July 2008 | ||||
| Completion Date | August 2009 | ||||
| Eligibility Criteria † | Inclusion criteria (abridged)
Exclusion criteria (abridged)Chronic migraine (>15 days of migraine/ month).
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Israel | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00640965 | ||||
| Organization ID | Ptcl-01325 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | D-Pharm Ltd. | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | D-Pharm Ltd. | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | March 17, 2008 | ||||
| Last Updated Date | March 17, 2008 | ||||