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Completed

NCT Number: NCT00497159

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

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.

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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

29 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

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 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.

Treatment and study plan

Placebo

Other

Placebo TID x 90 days

Dimebon

Drug

Dimebon 20 mg TID x 90 days

Primary outcomes

  1. To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.

    Time frame: 90 days

Secondary outcomes

  1. 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

  2. To assess the pharmacokinetics of Dimebon.

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Medivation, Inc.

Industry

Collaborators

  • Huntington Study Group

Registry information

Official study title

A Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease

Acronym: DIMOND

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 6, 2007
Registry last updated
Jun 8, 2015

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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