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NCT00387270 Clinical Trial

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

Huntington's Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00387270
Other study ID # DIM03
Secondary ID DIMOND
Status Completed
Phase Phase 1/Phase 2
First received October 10, 2006
Last updated January 3, 2008
Start date October 2006
Est. completion date March 2007

Study information
Verified date September 2007
Source Medivation, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Dimebon
Dimebon 10 or 20 mg TID x 7 days

Locations
Country Name City State
United States Huntington Study Group Rochester New York

Sponsors (2)
Lead Sponsor Collaborator
Medivation, Inc. Huntington Study Group

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dose-limiting toxicities 7 days Yes
Secondary Unified Huntington's Disease Rating Scale 7 days Yes
See also
  Status Clinical Trial Phase
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Completed NCT02956148 - Follow-up Measurement of Brain PDE10A Enzyme Levels in Huntington´s Disease Gene Expansion Carriers Early Phase 1
Terminated NCT02494778 - A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease Phase 2
Completed NCT02208934 - Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-999 in Healthy Young Male Volunteers Phase 1
Completed NCT02197130 - Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease Phase 2
Completed NCT02216474 - Brain Stimulation in Movement Disorders N/A
Completed NCT01806896 - Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease Phase 2
Completed NCT01502046 - Neuroprotection by Cannabinoids in Huntington's Disease Phase 2
Terminated NCT00712426 - Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E) Phase 3
Completed NCT00670709 - Examination of Quantitative Electroencephalographic (QEEG) Biomarkers in Huntington's Disease
Completed NCT00029874 - Minocycline in Patients With Huntington's Disease Phase 1/Phase 2
Terminated NCT02231580 - Study Exploring Safety, Pharmacokinetic and Pharmacodynamic of BN82451 in Male Huntington's Disease Patients Phase 2
Completed NCT02215616 - A Clinical Study in Participants With Huntington's Disease (HD) to Assess Efficacy and Safety of Three Oral Doses of Laquinimod Phase 2
Not yet recruiting NCT02551705 - Functional Imaging of Social Cognition in Premanifest Huntington's Disease N/A
Active, not recruiting NCT02101957 - Multicentric Trial of the Treatment of Huntington's Disease by Cysteamine (RP103) Phase 2/Phase 3
Completed NCT00975481 - A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users Phase 1
Completed NCT01521832 - Escalating Dose Study in Healthy Volunteers With SEN0014196 Phase 1
Completed NCT00990613 - A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin Phase 1
Completed NCT00095355 - Effects of Lithium and Divalproex`on Brain-Derived Neurotrophic Factor in Huntington's Disease Phase 2
Completed NCT00026988 - Creatine Therapy for Huntington's Disease Phase 1/Phase 2

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