Sponsored by Teva Branded Pharmaceutical Products, R&D Inc.
This trial offers continued treatment (involving pridopidine) to HD patients who previously completed the HART or the PRIDE-HD trial including the follow-up period, and remained on drug during the full on treatment part of the trial, and who have wished to continue their treatment.
This study is ongoing, but not recruiting participants.
A multi-center, North American, open-label extension study of pridopidine (ACR16) in the symptomatic treatment of Huntington’s Disease (Open-HART)
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.
Canadian Locations and Contact Information
Teva Investigational Site 048
Location: Centre for HD, UBC Hospital, Vancouver
Coordinator: Joji Decolongon
Phone: 604 875 3801
Teva Investigational Site 041
Status: Ongoing by not recruiting
Location: University of Alberta, Edmonton
Coordinator: Pam King
Teva Investigational Site 118
Status: Ongoing but not recruiting
Location: London Health Sciences Centre, London
Coordinator: Heather Russell
Teva Investigational Site 039
Status: Not Recruiting
Location: Centre for Movement Disorders, Toronto
Coordinator: Jonielyn Carlos
Phone: 416-847-7084 ext 235
Teva Investigational Site 231
Status: On going but not recruiting
Location: The Ottawa Hospital Civic Campus, Ottawa
Coordinator: Diane Cote
Exclusion Criteria (eligibility that would exclude you from this study)
- 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.
ClinicalTrials.gov A service of the U.S. National Institutes of Health
Information provided by (Responsible Party):Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
For more detailed information on this study and others and for the most recent updates, please go to clinicaltrials.gov. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.