Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease
Condition: Huntington Disease
MeSH terms: Huntington Disease
Intervention: pridopidine
Intervention description: 45mg bid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 134.0
Sex: All
Healthy volunteers: No
Keywords: Huntington Disease.

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.
    

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