An open-label extension study of the HORIZON protocol evaluating the safety of dimebon (latrepirdine)in subjects with Huntington disease.
- Successful completion of 26 weeks of blinded treatment in the HORIZON study
- Any other medical illness or unstable medical condition that may interfere with their
ability to comply with study procedures and abide by study restrictions, or may
interfere with the ability to interpret safety information.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | An Extension of the HORIZON Protocol Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease | ||
| Official Title ICMJE | HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease | ||
| Brief Summary | An open-label extension study of the HORIZON protocol evaluating the safety of dimebon (latrepirdine)in subjects with Huntington disease. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 3 | ||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||
| Condition ICMJE | Huntington Disease | ||
| Intervention ICMJE | Drug: Dimebon (latrepirdine) | ||
| Study Arms ICMJE | Experimental: Dimebon (latrepirdine) Patients receive dimebon 10mg orally 3 times per day for 1 week and 20 mg orally 3 times per day thereafter. Intervention: Drug: Dimebon (latrepirdine) | ||
| 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 | Terminated | ||
| Actual Enrollment ICMJE | 362 | ||
| Original Enrollment ICMJE | Not Provided | ||
| Study Completion Date ICMJE | Not Provided | ||
| Actual Primary Completion Date | June 2011 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | 30 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 | Not Provided | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT01085266 | ||
| Other Study ID Numbers ICMJE | DIM20EXT | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Medivation, Inc. | ||
| Study Sponsor ICMJE | Medivation, Inc. | ||
| Collaborators ICMJE | Pfizer | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Medivation, Inc. | ||
| Verification Date | October 2016 | ||
| 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
