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

Primary Purpose

Huntington Disease

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
pridopidine
Sponsored by
Prilenia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Huntington Disease focused on measuring Huntington Disease.

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    pridopidine

    Arm Description

    45mg bid

    Outcomes

    Primary Outcome Measures

    Number of Patients With at Least One Adverse Event

    Secondary Outcome Measures

    Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS)
    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.

    Full Information

    First Posted
    February 28, 2011
    Last Updated
    January 15, 2022
    Sponsor
    Prilenia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01306929
    Brief Title
    Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease
    Acronym
    OPEN-HART
    Official Title
    A Multi-Center, North American, Open-Label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington's Disease (Open-HART).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    March 24, 2011 (Actual)
    Primary Completion Date
    January 5, 2018 (Actual)
    Study Completion Date
    January 5, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Prilenia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Huntington Disease
    Keywords
    Huntington Disease.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    134 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    pridopidine
    Arm Type
    Experimental
    Arm Description
    45mg bid
    Intervention Type
    Drug
    Intervention Name(s)
    pridopidine
    Intervention Description
    45mg bid
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS)
    Description
    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.
    Time Frame
    Baseline and at Month 12, 24, 36, 48, 60, and 72

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    See Central Contact section for questions about
    Organizational Affiliation
    study officials
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32508327
    Citation
    McGarry A, Auinger P, Kieburtz K, Geva M, Mehra M, Abler V, Grachev ID, Gordon MF, Savola JM, Gandhi S, Papapetropoulos S, Hayden M. Additional Safety and Exploratory Efficacy Data at 48 and 60 Months from Open-HART, an Open-Label Extension Study of Pridopidine in Huntington Disease. J Huntingtons Dis. 2020;9(2):173-184. doi: 10.3233/JHD-190393.
    Results Reference
    background
    PubMed Identifier
    28826192
    Citation
    McGarry A, Kieburtz K, Abler V, Grachev ID, Gandhi S, Auinger P, Papapetropoulos S, Hayden M. Safety and Exploratory Efficacy at 36 Months in Open-HART, an Open-Label Extension Study of Pridopidine in Huntington's Disease. J Huntingtons Dis. 2017;6(3):189-199. doi: 10.3233/JHD-170241.
    Results Reference
    derived

    Learn more about this trial

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

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