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Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease (OPEN-HART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01306929
Recruitment Status : Active, not recruiting
First Posted : March 2, 2011
Last Update Posted : December 5, 2016
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief Summary:
Huntington disease (HD) is a hereditary neurodegenerative disorder causing impairment in movement, behavioral dysfunction and dementia. The movement disorder is mainly characterized by chorea (involuntary movements) and a progressive loss of voluntary movement causing a substantial functional impairment over time. The study will assess the long-term safety of pridopidine and the treatment effects during long-term, open-label treatment.

Condition or disease Intervention/treatment Phase
Huntington Disease Drug: pridopidine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, North American, Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease (Open-Hart)
Study Start Date : March 2011
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: pridopidine
45mg bid
Drug: pridopidine
45mg bid

Primary Outcome Measures :
  1. Number of subjects with at least one adverse event [ Time Frame: On average 2 years ]
    Long-term safety profile of pridopidine

Secondary Outcome Measures :
  1. Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score [ Time Frame: On average 2 years ]
    UHDRS development during long-term, open-label treatment of pridopidine

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject is able to, and has provided written Informed Consent prior to any study related procedure.
  • Subject has completed the HART (ACR16C009) trial, including the follow-up period, or the PRIDE-HD (TV7820-CNS-20002) trial , and has remained on drug during the on treatment part of the trial (including de-escalated subjects).
  • Willing and able to take oral medication and able to comply with the study specific procedures.

Exclusion Criteria:

  • Ongoing treatment with tetrabenazine seizure threshold lowering medications, , certain antipsychotics and antidepressants.
  • Newly instigated or changed treatment with neuroleptics/antipsychotics (< 6 weeks before Baseline Visit).
  • Use of tricyclic antidepressants or class I antiarrhythmics within 6 weeks of Baseline Visit, or at any time during the study period.
  • Any clinically significant, abnormal, laboratory result at any point during the randomized phase, including clinically significant hepatic or renal impairment, or any ongoing adverse events from the randomized phase, which in the opinion of the Investigator affects the subject's suitability for the study or puts the subject at risk if he/she enters the study.
  • A prolonged QTc interval at Baseline Visit (defined as a QTc interval of >450 msec for both males and females using Fredericia's formula , or other clinically significant heart conditions as judged by the investigator.
  • Severe intercurrent illness, which, in the opinion of the Investigator, may put the subject at risk when participating in the trial.
  • Alcohol and/or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis.
  • Subjects with suicidal ideation as defined as a positive score on criteria for major depressive episode, item A9 on the DSM -IV-TR criteria for a Major Depressive Episode.
  • Subjects with a known history of epilepsy or a history of febrile seizure(s) or seizure(s) of unknown cause.
  • Females who are pregnant or lactating.
  • Females who are of child bearing potential and not taking adequate contraceptive precautions (either oral, barrier or chemical contraceptives) are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions can be included.
  • Known allergy to any ingredients of the trial medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306929

United States, Indiana
Teva Investigational Site 045
Indianapolis, Indiana, United States
United States, Iowa
Teva Investigational Site 024
Iowa City, Iowa, United States
United States, Maryland
Teva Investigational Site 028
Baltimore, Maryland, United States
United States, New York
Teva Investigational Site 037
Albany, New York, United States
Teva Investigational Site 001
Rochester, New York, United States
United States, Ohio
Teva Investigational Site 089
Cincinnati, Ohio, United States
United States, Pennsylvania
Teva Investigational Site 018
Philadelphia, Pennsylvania, United States
United States, Washington
Teva Investigational Site 220
Kirkland, Washington, United States
Canada, British Columbia
Teva Investigational Site 048
Vancouver, British Columbia, Canada
Canada, Ontario
Teva Investigational Site 231
Ottawa, Ontario, Canada
Teva Investigational Site 118
London, Canada
Teva Investigational Site 039
Toronto, Canada
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Principal Investigator: Karl Kieburtz, MD, MPH University of Rochester

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT01306929     History of Changes
Other Study ID Numbers: ACR16C015
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016

Keywords provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):
Huntington Disease.

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders