Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease (OPEN-HART)
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ClinicalTrials.gov Identifier: NCT01306929 |
Recruitment Status
:
Completed
First Posted
: March 2, 2011
Last Update Posted
: March 14, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Huntington Disease | Drug: pridopidine | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: pridopidine
45mg bid
|
Drug: pridopidine
45mg bid
|
- Number of subjects with at least one adverse event [ Time Frame: On average 2 years ]Long-term safety profile of pridopidine
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306929
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 |
Principal Investigator: | Karl Kieburtz, MD, MPH | University of Rochester |
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 Key Record Dates |
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 |