A Study of the Novel Drug Dimebon in Patients With Huntington's Disease (DIMOND)

• ClinicalTrials.gov Identifier: NCT00497159
• Recruitment Status: Completed
• First Posted: July 6, 2007
• Last Update Posted: June 8, 2015
• Sponsor: Medivation, Inc.
• Collaborator: Huntington Study Group
• Information provided by (Responsible Party): Medivation, Inc.

Tracking Information

• First Submitted Date: July 3, 2007
• First Posted Date: July 6, 2007
• Last Update Posted Date: June 8, 2015
• Study Start Date: July 2007
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 26, 2007): To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease. [ Time Frame: 90 days ]
• Original Primary Outcome Measures (submitted: July 3, 2007): To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.
• Change History: Complete list of historical versions of study NCT00497159 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: December 26, 2007)

• To assess the impact of Dimebon during 3 months of treatment on cognitive, motor, and overall function in subjects with Huntington's Disease. [ Time Frame: 90 days ]
• To assess the pharmacokinetics of Dimebon. [ Time Frame: 90 days ]

Original Secondary Outcome Measures (submitted: July 3, 2007)

• To assess the impact of Dimebon during 3 months of treatment on cognitive, motor, and overall function in subjects with Huntington's Disease.
• To assess the pharmacokinetics of Dimebon.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of the Novel Drug Dimebon in Patients With Huntington's Disease
• Official Title: A Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease
• Brief Summary: This study will evaluate the safety of 3 months of Dimebon dosing and the efficacy of Dimebon in improving cognitive, motor, and overall function in subjects with Huntington's Disease.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Huntington's Disease

Intervention

• Other: Placebo
  Placebo TID x 90 days
• Drug: Dimebon
  Dimebon 20 mg TID x 90 days

Study Arms

• Placebo Comparator: 1
  Placebo
  Intervention: Other: Placebo
• Experimental: 2
  Dimebon
  Intervention: Drug: Dimebon

• Publications *: Kieburtz K, McDermott MP, Voss TS, Corey-Bloom J, Deuel LM, Dorsey ER, Factor S, Geschwind MD, Hodgeman K, Kayson E, Noonberg S, Pourfar M, Rabinowitz K, Ravina B, Sanchez-Ramos J, Seely L, Walker F, Feigin A; Huntington Disease Study Group DIMOND Investigators. A randomized, placebo-controlled trial of latrepirdine in Huntington disease. Arch Neurol. 2010 Feb;67(2):154-60. doi: 10.1001/archneurol.2009.334. Erratum in: Arch Neurol. 2010 Apr;67(4):492. Dimebon in Subjects With Huntington Disease (DIMOND)Investigators of the Huntington Study Group [corrected to Huntington Disease Study Group DIMOND Investigators].

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 16, 2015): 91
• Original Estimated Enrollment (submitted: July 3, 2007): 90
• Actual Study Completion Date: June 2008
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Clinical features of HD and a confirmatory family history of HD, and/or genetically confirmed HD;
• Able to take medication (capsules) by mouth.

Exclusion Criteria:

• Clinical evidence of unstable medical illness;
• Females who are pregnant or lactating or who intend to become pregnant during the study period.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 29 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00497159
• Other Study ID Numbers: DIM05
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Medivation, Inc.
• Study Sponsor: Medivation, Inc.
• Collaborators: Huntington Study Group

Investigators

• Principal Investigator: Karl Kieburtz, MD, MPH; Huntington Study Group, University of Rochester

• PRS Account: Medivation, Inc.
• Verification Date: May 2015