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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01306929
First received: February 28, 2011
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Huntington Disease
Drug: pridopidine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Number of subjects with at least one adverse event [ Time Frame: On average 2 years ] [ Designated as safety issue: No ]
    Long-term safety profile of pridopidine


Secondary Outcome Measures:
  • Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score [ Time Frame: On average 2 years ] [ Designated as safety issue: No ]
    UHDRS development during long-term, open-label treatment of pridopidine


Estimated Enrollment: 220
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pridopidine
45mg bid
Drug: pridopidine
45mg bid

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, 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 and/or seizure threshold lowering medications.
  • 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 males or > 470 msec for females), 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306929

  Hide Study Locations
Locations
United States, California
Ucsd School of Medicine
San Diego, California, United States, 92161
United States, Colorado
Colorado Neurological Institute Movement Disorders Center
Englewood, Colorado, United States, 80113-2759
United States, Indiana
Ndiana University School of Medicineoutpatient Clinical Research Facility
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Department of Psychiatry and Neurology
Iowa City, Iowa, United States, 52242
United States, Maryland
Johns Hopkins University Department of Psychiatry
Baltimore, Maryland, United States, 21287-7281
University of Maryland School of Medicine Department of Neurology
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
United States, Minnesota
Struthers Parkinson'S Center
Golden Valley, Minnesota, United States, 55427
United States, Missouri
Washington University School of Medicine Department of Neurology
St Louis, Missouri, United States, 63110
United States, New York
Parkinson'S Disease & Movement Disorders Ctr
Albany, New York, United States, 12208
Northshore Long Island Jewish Northshore Institute For Medical Research
Manhasset, New York, United States, 11030
University of Rochester Medical Center
Rochester, New York, United States, 14620
University of Rochester Department of Neurology
Rochester, New York, United States, 14618
United States, Ohio
University of Cincinatti/Cincinatti Childrens hospital
Cincinatti, Ohio, United States, 45221-0567
Ohio State University Parkinson'S Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Pennsylvania Hospital Penn Neurological Institute
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
University of Tennessee University of Tennessee Movement Disorder
Memphis, Tennessee, United States, 38163
United States, Texas
Un of Texas Southwestern Med Ctr At Dallas
Dallas, Texas, United States, 75390-9036
United States, Washington
Booth Gardner Parkinson'S Care Center
Kirkland, Washington, United States, 98034
Canada, Alberta
University of Alberta Glenrose Rehab Hosp Movement Disorder Clinic
Edmonton, Alberta, Canada, T5G 0B7
Canada, British Columbia
University of British Columbiaubc Hospital Dept of Medical Genetics
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
London Health Sciences Centreuniversity Hospital
London, Ontario, Canada, N6A 5A5
Centre For Movement Disorders the Centre For Addiction and Mental Health
Markham, Ontario, Canada, L6B1C9
Parkinsons &Neurodegenerative Disorder Clin
Ottawa, Ontario, Canada, K1G 4G3
Canada, Quebec
CHUM est NEUROLOGIE
Montreal, Quebec, Canada, H2L4M1
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Principal Investigator: Karl Kieburtz, MD, MPH University of Rochester
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01306929     History of Changes
Other Study ID Numbers: ACR16C015
Study First Received: February 28, 2011
Last Updated: March 13, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Teva Pharmaceutical Industries:
Huntington Disease.

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013