NCT01085266

Brief Summary

An open-label extension study of the HORIZON protocol evaluating the safety of dimebon (latrepirdine)in subjects with Huntington disease.

Trial Health

10
At Risk

Trial Health Score

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

Enrollment
362

participants targeted

Target at P50-P75 for phase_3

Status
terminated

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

February 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

March 10, 2010

Last Update Submit

October 11, 2016

Conditions

Huntington Disease

Study Arms (1)

Dimebon (latrepirdine)

EXPERIMENTAL

Patients receive dimebon 10mg orally 3 times per day for 1 week and 20 mg orally 3 times per day thereafter.

Drug: Dimebon (latrepirdine)

Interventions

Dimebon (latrepirdine)DRUG
Dimebon (latrepirdine)

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Successful completion of 26 weeks of blinded treatment in the HORIZON study

You may not qualify if:

  • Any other medical illness or unstable medical condition that may interfere with their ability to comply with study procedures and abide by study restrictions, or may interfere with the ability to interpret safety information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2010

First Posted

March 11, 2010

Study Start

February 1, 2010

Primary Completion

June 1, 2011

Last Updated

October 12, 2016

Record last verified: 2016-10