Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease (OPEN-HART)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
First received: February 28, 2011
Last updated: April 28, 2015
Last verified: April 2015
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Multi-center, North American, Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease (Open-Hart)
Primary Outcome Measures:
Secondary Outcome Measures:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2016 (Final data collection date for primary outcome measure)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01306929
Teva Branded Pharmaceutical Products, R&D Inc.
||Karl Kieburtz, MD, MPH
||University of Rochester
No publications provided
||Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 28, 2011
||April 28, 2015
||United States: Food and Drug Administration
Canada: Health Canada
Keywords provided by Teva Pharmaceutical Industries:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 03, 2015
Basal Ganglia Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Nervous System Diseases