A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Dyskinesias
Intervention: Pridopidine; Placebo
Intervention description: Oral capsule; Oral capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 30 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Levodopa; Dyskinesia

Summary:

      This is a multicenter, randomized, three-arm, parallel-group, double-blind,
      placebo-controlled, study to evaluate the efficacy, safety and pharmacokinetics (PK) of
      pridopidine vs. placebo for the treatment of Levodopa Induced Dyskinesia (LID) in patients
      with Parkinson Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provides signed informed consent form.

          -  Has clinical diagnosis of Parkinson's Disease (PD).

          -  Has Levodopa-induced dyskinesia (LID).

          -  Patient and/or study partner must demonstrate ability to keep accurate home diary of
             PD symptoms.

          -  Has stable anti-PD treatments for at least 28 days prior to start of study treatment
             and kept constant throughout study.

          -  All routine and allowed prescription/non-prescription medications and/or nutritional
             supplements taken regularly must be at stable dosage for at least 28 days prior to
             start of study treatment and maintained throughout study.

        Exclusion Criteria:

          -  Diagnosis of atypical Parkinsonism.

          -  Treatment with dopamine blocking drugs.

          -  History of surgical intervention related to PD, such as deep brain stimulation.

          -  History of severe depression, psychosis or hallucinations within 6 months prior to
             screening; active suicidal ideation; or suicidal attempt within 5 years prior to
             screening.

          -  History of certain cancers within 5 years prior to screening.

          -  Significant cardiac event within 12 weeks prior to Baseline or history of certain
             cardiac arrhythmias.

          -  History of epilepsy or seizures within 5 years prior to screening.

          -  Females who are pregnant or breastfeeding.

          -  Sexually active female patients who are not surgically sterile or at least 2 years
             postmenopausal prior to screening, and who do not agree to utilize a highly effective
             hormonal method of contraception in combination with a barrier method, from screening
             until at least 4 weeks after completion of study treatment.

          -  Male patients not using highly effective contraception or not agreeing to continue
             highly effective contraception until at least 90 days after the completion of study
             treatment.

          -  Treatment with any investigational product within 30 days of screening or plans to
             participate in another clinical study assessing any investigational product during the
             study.

        Other protocol-defined inclusion/exclusion criteria could apply.