Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease
This study has been completed.
Sponsor:
Medivation, Inc.
Collaborator:
Huntington Study Group
Information provided by:
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00387270
First received: October 10, 2006
Last updated: January 3, 2008
Last verified: September 2007
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 10, 2006 | ||||
| Last Updated Date | January 3, 2008 | ||||
| Start Date ICMJE | October 2006 | ||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Dose-limiting toxicities [ Time Frame: 7 days ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Dose-limiting toxicities | ||||
| Change History | Complete list of historical versions of study NCT00387270 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Unified Huntington's Disease Rating Scale [ Time Frame: 7 days ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
Unified Huntington's Disease Rating Scale | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease | ||||
| Official Title ICMJE | A Multicenter, Phase 1-2A, Open-Label, Dosage-Escalation and Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease | ||||
| Brief Summary | This study is being conducted to determine the safety and tolerability of Dimebon in people with Huntington's disease after short-term exposure (one week) and after longer exposure (three months). Also, the study will assess whether or not there is an effect of Dimebon on the symptoms of Huntington's disease, including cognitive (thinking abilities), motor (movement), behavior, and overall functioning. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Huntington's Disease | ||||
| Intervention ICMJE | Drug: Dimebon
Dimebon 10 or 20 mg TID x 7 days |
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| Study Arm (s) | Experimental: A
Dimebon
Intervention: Drug: Dimebon |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 9 | ||||
| Completion Date | March 2007 | ||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00387270 | ||||
| Other Study ID Numbers ICMJE | DIM03, DIMOND | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Karl Kieburtz, MD, Clinical Trial Coordination Center | ||||
| Study Sponsor ICMJE | Medivation, Inc. | ||||
| Collaborators ICMJE | Huntington Study Group | ||||
| Investigators ICMJE |
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| Information Provided By | Medivation, Inc. | ||||
| Verification Date | September 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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