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.
- Clinical features of Huntington's disease and a confirmatory family history of HD, or
a CAG repeat expansion greater than or equal to 36
- Stage I,II,III HD and a total functional capacity greater than or equal to 5 on the
Unified Huntington's Disease Rating Scale
- Clinical evidence of unstable medical illness
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 Phase 2 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Huntington's Disease | |||
| Intervention ICMJE | Drug: Dimebon Dimebon 10 or 20 mg TID x 7 days | |||
| Study Arms ICMJE | Experimental: A Dimebon Intervention: Drug: Dimebon | |||
| Publications * | Not Provided | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 9 | |||
| Original Enrollment ICMJE | 75 | |||
| Actual Study Completion Date ICMJE | March 2007 | |||
| Actual Primary Completion Date | March 2007 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00387270 | |||
| Other Study ID Numbers ICMJE | DIM03 DIMOND | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Karl Kieburtz, MD, Clinical Trial Coordination Center | |||
| Study Sponsor ICMJE | Medivation, Inc. | |||
| Collaborators ICMJE | Huntington Study Group | |||
| Investigators ICMJE |
| |||
| PRS Account | Medivation, Inc. | |||
| Verification Date | September 2007 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
