A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Intervention: Pridopidine; Placebo
Intervention description: 22.5 mg and 45 mg capsules; Capsules matching drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 408.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Huntington's Disease; Pridopidine; Pride-HD

Summary:

      This is a multicenter, multinational, randomized, parallel-group, double-blind,
      placebo-controlled, dose range finding study to compare the efficacy and safety of different
      doses of pridopidine versus placebo in the treatment of motor impairment in Huntington's
      Disease (HD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of HD based on the presence of >/= 36 CAG repeats

          -  Male or female age ≥21 years, with an onset of HD after 18 years' old.

          -  Females of childbearing potential must be compliant in using adequate birth control
             throughout the duration of the study

          -  Body weight ≥50 kg

          -  Sum of >= 25 points on the UHDRS-TMS and UHDRS Independence Score <=90%

          -  Able and willing to provide written informed consent prior to any study related
             procedure.

          -  Willing to provide a blood sample for genetic analyses

          -  Willing and able to take oral medication and able to comply with the study specific
             procedures.

          -  Ambulatory, being able to travel to the study center, and judged by the investigator
             as likely to be able to continue to travel for the duration of the study.

          -  Availability and willingness of a caregiver, informant or family member to accompany
             the patient to the clinic at study, and the suitability of the caregiver should be
             judged by the Investigator.

               -  Other criteria apply, please contact the investigator for more information.

        Exclusion Criteria:

          -  Patients with clinically significant heart disease at the screening visit

          -  Treatment with tetrabenazine within 6 weeks of study screening

          -  Patients with a history of epilepsy or of seizures within the last 5 years

          -  Have other serious medical illnesses in the opinion of the investigator may put the
             patient at risk when participating in the study or may influence the results of the
             study or affect the patient's ability to take part in the study

          -  Patients receiving medications (within the last 6 weeks prior to screening) that have
             been proven to prolong QT interval or who may require such medications during the
             course of the study such as but not limited to non allowed anti psychotic medications,
             tricyclic antidepressants and/or Class I antiarrhythmics

               -  Other criteria apply, please contact the investigator for more information