Study of Memantine to Treat Huntington's Disease
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by University of California, San Diego.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of California, San Diego
Collaborator:
Forest Laboratories
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00652457
First received: March 31, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 31, 2008 | ||||||||
| Last Updated Date | March 31, 2008 | ||||||||
| Start Date ICMJE | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
sensitive neuropsychological battery [ Time Frame: three months and six months of treatment ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
behavioral and functional measures at three and six months of treatment [ Time Frame: three and six months of treatment ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Memantine to Treat Huntington's Disease | ||||||||
| Official Title ICMJE | A Pilot Study of Memantine for Cognitive and Behavioral Dysfunction in Huntington's Disease" | ||||||||
| Brief Summary | To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in patients with Huntington's disease (HD). |
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| Detailed Description | Results of several published clinical trials suggest that memantine has a beneficial effect in dementing conditions, such as Alzheimer's disease; however, the effects of memantine on cognitive and behavioral function in HD are unknown. Our hypotheses are that HD patients who are administered memantine will show improved performance on psychometric tests of memory and executive functions in addition to behavior and that patients treated with memantine will show more improvement after six months than after three months of treatment. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Huntington's Disease | ||||||||
| Intervention ICMJE | Drug: Memantine
10 mg BID x 3 months
Other Name: Namenda |
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| Study Arm (s) | Experimental: 1
Memantine 10 mg BID for three months
Intervention: Drug: Memantine |
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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 | Recruiting | ||||||||
| Enrollment ICMJE | 60 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00652457 | ||||||||
| Other Study ID Numbers ICMJE | MEM-HD | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Jody Corey-Bloom, MD, PhD, Department of Neurosciences, University of California San Diego | ||||||||
| Study Sponsor ICMJE | University of California, San Diego | ||||||||
| Collaborators ICMJE | Forest Laboratories | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | University of California, San Diego | ||||||||
| Verification Date | March 2008 | ||||||||
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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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