Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00387270
• Date of registration: 10/10/2006
• Prospective Registration: No
• Primary sponsor: Medivation, Inc.
• Public title: Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease
• Scientific title: A Multicenter, Phase 1-2A, Open-Label, Dosage-Escalation and Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease
• Date of first enrolment: October 2006
• Target sample size: 9
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00387270
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Karl D Kieburtz, MD
• Affiliation: University of Rochester Medical School, Huntington Study Group

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- Clinical evidence of unstable medical illness



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Huntington's Disease

Intervention(s)

Drug: Dimebon

Primary Outcome(s)

Dose-limiting toxicities [Time Frame: 7 days]

Secondary Outcome(s)

Unified Huntington's Disease Rating Scale [Time Frame: 7 days]

Secondary ID(s)

DIM03

DIMOND

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Huntington Study Group