A Study of the Novel Drug Dimebon in Patients With Huntington's Disease
DIMOND
A Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease
1 other identifier
interventional
91
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 3, 2007
CompletedFirst Posted
Study publicly available on registry
July 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedJune 8, 2015
May 1, 2015
11 months
July 3, 2007
May 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.
90 days
Secondary Outcomes (2)
To assess the impact of Dimebon during 3 months of treatment on cognitive, motor, and overall function in subjects with Huntington's Disease.
90 days
To assess the pharmacokinetics of Dimebon.
90 days
Study Arms (2)
1
PLACEBO COMPARATORPlacebo
2
EXPERIMENTALDimebon
Interventions
Eligibility Criteria
You may qualify if:
- Clinical features of HD and a confirmatory family history of HD, and/or genetically confirmed HD;
- Able to take medication (capsules) by mouth.
You may not qualify if:
- Clinical evidence of unstable medical illness;
- Females who are pregnant or lactating or who intend to become pregnant during the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medivation, Inc.lead
- Huntington Study Groupcollaborator
Study Sites (1)
Huntington Study Group
Rochester, New York, 14620, United States
Related Publications (1)
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.
PMID: 20142523DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karl Kieburtz, MD, MPH
Huntington Study Group, University of Rochester
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2007
First Posted
July 6, 2007
Study Start
July 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
June 8, 2015
Record last verified: 2015-05