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Completed

NCT Number: NCT00387270

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

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.

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Key information

Conditions

Huntington's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Huntington Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Huntington Study Group

Rochester, New York, 14620, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dimebon

Drug

Dimebon 10 or 20 mg TID x 7 days

Primary outcomes

  1. Dose-limiting toxicities

    Time frame: 7 days

Secondary outcomes

  1. Unified Huntington's Disease Rating Scale

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Medivation, Inc.

Industry

Collaborators

  • Huntington Study Group

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 12, 2006
Registry last updated
Jan 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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