A Study of Pridopidine (ACR16) for the Treatment of Participants With Huntington's Disease
Condition: Huntington Disease
MeSH terms: Huntington Disease
Intervention: ACR16; Placebo
Intervention description: ACR16 will be administered per dose and schedule specified in the arm description.; Placebo matching to ACR16 will be administered per schedule specified in the arm description.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 227.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Huntington Disease

Summary:

      The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic
      treatment of Huntington's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide written Informed Consent prior to any study related procedure,
             including consent to genotyping of the CYP2D6 gene.

          -  Clinical features of HD, and a positive family history and/or the presence of ≥ 36 CAG
             repeats in the Huntington gene.

          -  Male or female age ≥ 30 years.

          -  Willing and able to take oral medication and to comply with the study specific
             procedures.

          -  Ambulatory, being able to travel to the assessment center, and judged by the
             Investigator as likely to be able to continue to travel for the duration of the study.

          -  Availability of a caregiver or family member to accompany the participant to two
             visits.

          -  A sum of ≥ 10 points on the mMS at the screening visit.

          -  For participants taking allowed antidepressants or other psychotropic medication , the
             dosing of medication must have been kept constant for at least 6 weeks before baseline
             visit.

        Exclusion Criteria:

          -  Treatment with any antipsychotic medication (neuroleptics) within 8 weeks of baseline
             visit, or at any time point during the study period.

          -  Use of tetrabenazine within 12 weeks of baseline visit, or at any time during the
             study period.

          -  Treatment with any investigational product within 4 weeks of baseline visit.

          -  Use of tricyclic antidepressants or class I antiarrhythmics within 6 weeks of baseline
             visit, or at any time during the study period.

          -  Use of concomitant medication that may lower the seizure threshold within 6 weeks of
             baseline visit, or at any time during the study period .

          -  Use of metoclopramide within 12 weeks of baseline visit, or at any time during the
             study period.

          -  Participants currently receiving deep brain stimulation (DBS).

          -  Participants with a history of surgical procedures aiming to improve the symptoms of
             Huntington disease, such as neural transplantations, lesions of the central nervous
             system, infusions of neurotrophic agents or previous attempts of deep brain
             stimulation.

          -  Participants previously randomized into this study.

          -  A prolonged QTc interval at Screening Visit (defined as a QTc interval of > 450
             milliseconds [msec] for males or > 470 msec for females), or other clinically
             significant heart conditions as judged by the investigator.

          -  Creatinine clearance <40 milliliters (mL)/minute (min) as measured at the screening
             visit.

          -  Any clinically significant, abnormal, baseline laboratory result which in the opinion
             of the Investigator, affects the participant' suitability for the study or puts the
             participant at risk if he/she enters the study.

          -  Clinically significant hepatic or renal impairment.

          -  Participants with a known history of epilepsy or a history of febrile seizure(s) or
             seizure(s) of unknown cause.

          -  Severe intercurrent illness, which, in the opinion of the Investigator, may put the
             participant at risk when participating in the trial or may influence the results of
             the trial or affect the subjects' ability to take part in the trial.

          -  Alcohol and/or drug abuse as defined by Diagnostic and Statistical Manual of Mental
             Disorders, 4th Edition, Text Revision (DSM IV-TR) criteria for Substance Abuse - this
             includes the illicit use of cannabis within the last 12 months prior to Screening
             Visit

          -  Participants with suicidal ideation as defined as a positive score on criteria for
             major depressive episode, item A9 on the DSM -IV-TR criteria for a Major Depressive
             Episode

          -  Females who are pregnant or lactating or who intend to become pregnant during the
             study period.

          -  Females who are of child bearing potential and not taking adequate contraceptive
             precautions are excluded from the trial. (Females of childbearing potential taking
             acceptable contraceptive precautions can be included)

          -  Known allergy to any ingredients of the trial medication or placebo

          -  Any previous participation in a clinical study with ACR16.