NCT00387270

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 4, 2008

Status Verified

September 1, 2007

Enrollment Period

5 months

First QC Date

October 10, 2006

Last Update Submit

January 3, 2008

Conditions

Huntington's Disease

Keywords

Huntington's diseaseDimebondose-escalationPhase 1-2arandomizedcontrolleddouble-blindUnified Huntington's Disease Rating Scale

Outcome Measures

Primary Outcomes (1)

  • Dose-limiting toxicities

    7 days

Secondary Outcomes (1)

  • Unified Huntington's Disease Rating Scale

    7 days

Study Arms (1)

A

EXPERIMENTAL

Dimebon

Drug: Dimebon

Interventions

DimebonDRUG

Dimebon 10 or 20 mg TID x 7 days

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Clinical evidence of unstable medical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huntington Study Group

Rochester, New York, 14620, United States

Location

Related Links

MeSH Terms

Conditions

Huntington Disease

Interventions

latrepirdine

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Karl D Kieburtz, MD

    University of Rochester Medical School, Huntington Study Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 10, 2006

First Posted

October 12, 2006

Study Start

October 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

January 4, 2008

Record last verified: 2007-09

Locations

US(1)