A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease (HORIZON)

October 11, 2016 updated by: Medivation, Inc.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Mile-to-Moderate Huntington Disease

The purpose of this study is to determine if Dimebon is safe and effective for the treatment of cognitive impairment in Huntington disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter Phase 3, randomized, double-blind, placebo-controlled safety and efficacy study of Dimebon treatment in subjects with Huntington disease (HD). The study will evaluate Dimebon 20 mg three times daily (TID) administered orally (PO) for six months (26 weeks) compared with matching placebo TID for the primary safety and efficacy analyses. Safety and tolerability will be assessed by recording of adverse events and by monitoring of vital signs, physical examinations, safety laboratory evaluations, and 12-lead electrocardiogram(ECG)assessments.

Study Type

Interventional

Enrollment (Actual)

403

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Perth, Australia
    • New South Wales
      • Wentworthville, New South Wales, Australia
    • Victoria
      • Melbourne, Victoria, Australia
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • London, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Denmark
      • Copenhagen, Denmark
  • Germany
      • Aachen, Germany
      • Bochum, Germany
      • Hamburg, Germany
    • Ulm
      • Oberer Eslebberg, Ulm, Germany
  • Sweden
      • Stockholm, Sweden
  • United Kingdom
      • Birmingham, United Kingdom
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
    • California
      • Davis, California, United States, 95616
      • Irvine, California, United States, 92697
      • La Jolla, California, United States, 92161
      • San Francisco, California, United States, 94143
    • Florida
      • Gainsville, Florida, United States, 32610
      • Miami, Florida, United States, 33136
    • Idaho
      • Boise, Idaho, United States, 83702
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Kansas
      • Kansas City, Kansas, United States, 66160
      • Wichita, Kansas, United States, 67206
    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
    • Minnesota
      • Golden Valley, Minnesota, United States, 55427
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • New York
      • New York, New York, United States, 10032
      • Rochester, New York, United States, 14620
    • North Carolina
      • Durham, North Carolina, United States, 27705
      • Winstom-Salem, North Carolina, United States, 27157
    • Ohio
      • Cleveland, Ohio, United States, 44195
      • Columbus, Ohio, United States, 43210
    • Oregon
      • Portland, Oregon, United States, 97201
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
      • Pittsburgh, Pennsylvania, United States, 15213
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have clinical features of HD and a CAG polyglutamate repeat expansion ≥ 36

  • Have cognitive impairment as noted by the following:

    1. A Screening MMSE AND a baseline (pre-dose) MMSE score between 10 and 26 (inclusive); and
    2. A subjective assessment of cognitive impairment with decline from pre-HD levels by the Investigator after interviewing the subject and caregiver;
  • Are willing and able to give informed consent
  • Aged 30 years or older
  • Have a caregiver who assists/spends time with the subject at least five days per week for at least three hours per day and has intimate knowledge of the subject's cognitive, functional, and emotional states, and of the subject's personal care.

Exclusion Criteria:

  • Had onset of symptoms prior to age 18
  • Have any major medical illness or unstable medical condition within 180 days of screening that may interfere with the subject's ability to comply with study procedures and abide by study restrictions, or with the ability to interpret safety data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Orally TID
Experimental: Dimebon
Drug: Dimebon
20 mg Dimebon orally TID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A comparison between the mean changes from baseline in the Dimebon 20 mg TID treatment group and the placebo group on the MMSE
Time Frame: Week 26
Week 26
A comparison of the distributions of the CIBIC-plus (ADCS CGIC)in the Dimebon 20 mg TID treatment group and the placebo group
Time Frame: Week 26
Week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the NPI
Time Frame: Week 26
Week 26
A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the ADCS-ADL
Time Frame: Week 26
Week 26
A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the UHDRS'99 Total Motor Score
Time Frame: Week 26
Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medivation, Inc.

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

June 12, 2009

First Submitted That Met QC Criteria

June 12, 2009

First Posted (Estimate)

June 15, 2009

Study Record Updates

Last Update Posted (Estimate)

October 12, 2016

Last Update Submitted That Met QC Criteria

October 11, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIM20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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