Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease
This trial is active, not recruiting.
|Sponsor||Teva Branded Pharmaceutical Products, R&D Inc.|
|Start date||March 2011|
|End date||April 2021|
|Trial size||235 participants|
|Trial identifier||NCT01306929, ACR16C015|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Indianapolis, IN||Teva Investigational Site 045||no longer recruiting|
|Iowa City, IA||Teva Investigational Site 024||no longer recruiting|
|Baltimore, MD||Teva Investigational Site 028||no longer recruiting|
|Albany, NY||Teva Investigational Site 037||no longer recruiting|
|Rochester, NY||Teva Investigational Site 001||no longer recruiting|
|Cincinnati, OH||Teva Investigational Site 089||no longer recruiting|
|Philadelphia, PA||Teva Investigational Site 018||no longer recruiting|
|Kirkland, WA||Teva Investigational Site 220||no longer recruiting|
|Markham, Canada||Teva Investigational Site 039||no longer recruiting|
|Ottawa, Canada||Teva Investigational Site 231||no longer recruiting|
|London, Canada||Teva Investigational Site 118||no longer recruiting|
|Vancouver, Canada||Teva Investigational Site 048||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Number of subjects with at least one adverse event
time frame: On average 2 years
Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score
time frame: On average 2 years
Male or female participants of any age.
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.
|Official title||A Multi-center, North American, Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease (Open-Hart)|
|Principal investigator||Karl Kieburtz, MD, MPH|
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