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

Primary Purpose

Huntington Disease

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Dimebon (latrepirdine)
Sponsored by
Medivation, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Huntington Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Dimebon (latrepirdine)

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 10, 2010
    Last Updated
    October 11, 2016
    Sponsor
    Medivation, Inc.
    Collaborators
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01085266
    Brief Title
    An Extension of the HORIZON Protocol Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease
    Acronym
    HORIZON PLUS
    Official Title
    HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Terminated
    Study Start Date
    February 2010 (undefined)
    Primary Completion Date
    June 2011 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medivation, Inc.
    Collaborators
    Pfizer

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Huntington Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    362 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dimebon (latrepirdine)
    Arm Type
    Experimental
    Arm Description
    Patients receive dimebon 10mg orally 3 times per day for 1 week and 20 mg orally 3 times per day thereafter.
    Intervention Type
    Drug
    Intervention Name(s)
    Dimebon (latrepirdine)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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