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

A Multicenter, Phase 1-2A, Open-Label, Dosage-Escalation and Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00387270

Enrollment

Registered

2006-10-12

Start date

2006-10-31

Completion date

2007-03-31

Last updated

2008-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Huntington's Disease

Keywords

Huntington's disease, Dimebon, dose-escalation, Phase 1-2a, randomized, controlled, double-blind, Unified Huntington's Disease Rating Scale

Brief summary

This study is being conducted to determine the safety and tolerability of Dimebon in people with Huntington's disease after short-term exposure (one week) and after longer exposure (three months). Also, the study will assess whether or not there is an effect of Dimebon on the symptoms of Huntington's disease, including cognitive (thinking abilities), motor (movement), behavior, and overall functioning.

Interventions

DRUGDimebon

Dimebon 10 or 20 mg TID x 7 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Dose-limiting toxicities	7 days

Secondary

Measure	Time frame
Unified Huntington's Disease Rating Scale	7 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026