A Study of Treatment With Pridopidine (ACR16) in Participants With Huntington's Disease
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Intervention: ACR16; Placebo
Intervention description: Capsules will be swallowed whole with water.; Capsules will be swallowed whole with water.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 437.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Huntington's 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.

          -  Huntington's disease diagnosed with the aid of clinical features 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 able to comply with the study specific
             procedures.

          -  Ambulatory, being able to travel to the assessment centre, 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.

          -  A sum of ≥ 10 points on the mMS at the screening visit.

          -  For participants taking allowed antipsychotic medication, the dosing of medication
             must have been kept constant for at least 6 weeks before randomization. The allowed
             antipsychotic medication is Amisulpride, Haloperidol, Olanzapine, Risperidone,
             Sulpiride, or Tiapride.

          -  For participants taking allowed antidepressant or other psychotropic medication, the
             dosing of medication must have been kept constant for at least 6 weeks before
             randomization.

          -  Willing to provide a blood sample for CAG analysis (where CAG result is not already
             available).

          -  In France only, the participant must be affiliated to a social security system or be a
             beneficiary of such a system.

        Exclusion Criteria:

          -  Unable to give written informed consent.

          -  Treatment with any non-allowed antipsychotic medication within 12 weeks of
             randomization. The non-allowed antipsychotic medication is any medication other than
             Amisulpride, Haloperidol, Olanzapine, Risperidone, Sulpiride, or Tiapride.

          -  Treatment with the antidepressants Fluoxetine or Paroxetine within 6 weeks of
             randomization.

          -  Use of Tetrabenazine within 12 weeks of randomization, or at any time during the study
             period.

          -  Treatment with any investigational product within 4 weeks of randomization.

          -  Use of tricyclic antidepressants, class I antiarrhythmics, and strong CYP2D6
             inhibitors such as Ajmalicine, Chinidin/Quinidine and Ritonavir, within 6 weeks of
             randomization.

          -  Participants previously included into this study.

          -  A prolonged QTc interval at screen (defined as a QTc interval of > 450 milliseconds
             [msec] for males or > 470 msec for females), or other clinically significant heart
             conditions.

          -  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 participants' 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 history of epilepsy or a history of 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 participants' ability to take part in the trial.

          -  Alcohol and/or drug abuse as defined by Diagnostic and Statistical Manual - Fourth
             Edition - Text Revision (DSM IV-TR) criteria for substance abuse - this includes the
             illicit use of cannabis within the last 12 months.

          -  Participants with suicidal ideation, 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.

          -  Females who are of child bearing potential and not taking adequate contraceptive
             precautions 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 or placebo.

          -  Any previous participation in a clinical study with ACR16.

          -  Participants currently receiving deep brain stimulation.

          -  Participants with a history of surgical procedures aiming to improve the symptoms of
             Huntington's disease, such as neural transplantations, lesions of the central nervous
             system, infusions of neurotrophic agents or previous attempts of deep brain
             stimulation.