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: July 25, 2014
Last verified: July 2014
  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


Enrollment: 118
Study Start Date: March 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: December 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306929

  Show 22 Study Locations
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: July 25, 2014
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 September 30, 2014