An Extension of the HORIZON Protocol Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease

NCT ID: NCT01085266

Last Updated: 2016-10-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 362 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28

Brief Summary

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

Conditions

Huntington Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dimebon (latrepirdine)

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

Group Type: EXPERIMENTAL

Dimebon (latrepirdine)

Intervention Type: DRUG

Interventions

Dimebon (latrepirdine)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Medivation, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

DIM20EXT

Identifier Type: -

Identifier Source: org_study_id