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Trial record 2 of 2 for:    hart acr16

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01306929
Recruitment Status : Completed
First Posted : March 2, 2011
Results First Posted : February 9, 2022
Last Update Posted : February 9, 2022
Sponsor:
Information provided by (Responsible Party):
Prilenia

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: N/A
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 24, 2011
Actual Primary Completion Date : January 5, 2018
Actual Study Completion Date : January 5, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of Patients With at Least One Adverse Event [ Time Frame: From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years ]

Secondary Outcome Measures :
  1. Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS) [ Time Frame: Baseline and at Month 12, 24, 36, 48, 60, and 72 ]
    TMS was defined as the sum of all UHDRS motor domains ratings. The motor section of the UHDRS assesses motor features of Huntington's Disease (HD) with standardized ratings of oculo-motor function, dysarthria, chorea, dystonia, gait, and postural stability. Each of 31 assessments is rated on a scale of 0 (normal) to 4 (marked impairment) for a TMS range of 0-124.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Prilenia
Investigators
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Principal Investigator: See Central Contact section for questions about study officials
  Study Documents (Full-Text)

Documents provided by Prilenia:
Study Protocol  [PDF] June 29, 2017
Statistical Analysis Plan  [PDF] January 11, 2018

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prilenia
ClinicalTrials.gov Identifier: NCT01306929    
Other Study ID Numbers: ACR16C015
First Posted: March 2, 2011    Key Record Dates
Results First Posted: February 9, 2022
Last Update Posted: February 9, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prilenia:
Huntington Disease.
Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders