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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Huntington Disease	Drug: pridopidine	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	235 participants
Intervention Model:	Single Group Assignment
Masking:	None (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's Disease (Open-HART).
Actual Study Start Date :	March 1, 2011
Actual Primary Completion Date :	January 5, 2018
Actual Study Completion Date :	January 5, 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: pridopidine; 45mg bid	Drug: pridopidine; 45mg bid

Outcome Measures

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Primary Outcome Measures :

1. Number of subjects with at least one adverse event [ Time Frame: On average 2 years ]
   Long-term safety profile of pridopidine

Secondary Outcome Measures :

1. Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score [ Time Frame: On average 2 years ]
   UHDRS development during long-term, open-label treatment of pridopidine

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Subject is able to, and has provided written Informed Consent prior to any study related procedure.
• Patient has completed the HART (ACR16C009) or the PRIDE-HD (TV7820- CNS-20002) studies and had remained on IMP during the full on-treatment part of the study (including de-escalated patients) or has transitioned from the Open-HART pre-virtualization study period.
• Willing and able to take oral medication and able to comply with the study specific procedures.
• Patient has a wireless internet connection at home (and/or applicable locations) at the first remote visit.

• Patient has the ability to transition from in-person study visits to virtual study visits. The first remote visit (RV1) will take place within approximately 30 days after the last in-person visit.

  • Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

• Ongoing treatment with tetrabenazine or deutetrabenazine, seizure threshold lowering medications, or certain antipsychotics and antidepressants.
• Newly instigated or changed treatment with neuroleptics/antipsychotics
• Use of tricyclic antidepressants or class I & III antiarrhythmics at any time during the study period.
• Severe intercurrent illness that, in the opinion of the Investigator (or qualified designee), may put the subject at risk when continuing participation in the study.
• Alcohol and/or drug abuse as defined by the Diagnostic and Statistical Manual - Fourth Edition - Text Revision criteria for substance abuse - this includes the illicit use of cannabis.
• 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.

  • Additional criteria apply, please contact the investigator for more information

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Indiana
Teva Investigational Site 045
Indianapolis, Indiana, United States, 46202
United States, Iowa
Teva Investigational Site 024
Iowa City, Iowa, United States, 52242
United States, Maryland
Teva Investigational Site 028
Baltimore, Maryland, United States, 21287
United States, New York
Teva Investigational Site 037
Albany, New York, United States, 12208
Teva Investigational Site 001
Rochester, New York, United States, 14620
United States, Ohio
Teva Investigational Site 089
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Teva Investigational Site 018
Philadelphia, Pennsylvania, United States, 19107
United States, Washington
Teva Investigational Site 220
Kirkland, Washington, United States, 98034
Canada, British Columbia
Teva Investigational Site 048
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
Teva Investigational Site 231
Ottawa, Ontario, Canada, K1G 4G3
Canada
Teva Investigational Site 118
London, Canada, N6A 5A5
Teva Investigational Site 039
Toronto, Canada, M3B 2S7

Sponsors and Collaborators

Teva Branded Pharmaceutical Products, R&D Inc.

Investigators

Principal Investigator:	Karl Kieburtz, MD, MPH	University of Rochester

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier:	NCT01306929 History of Changes
Other Study ID Numbers:	ACR16C015
First Posted:	March 2, 2011
Last Update Posted:	March 14, 2018
Last Verified:	March 2018

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):

Huntington Disease.

Additional relevant MeSH terms:

Chorea; Huntington Disease; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Dyskinesias	Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Cognition Disorders; Neurocognitive Disorders; Mental Disorders