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

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Randomized, Three-Arm, Parallel-Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine Versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease (gLIDe)

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Pridopidine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pridopidine Dose 1<br>Dose 1 (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period | Drug: Pridopidine<br>* Oral capsule<br>Drug: Placebo<br>* Oral capsule<br>|
| Experimental: Pridopidine Dose 2<br>Dose 2 for (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period | Drug: Pridopidine<br>* Oral capsule<br>|
| Placebo Comparator: Placebo<br>Matching placebo (oral capsule) for 16 weeks | Drug: Placebo<br>* Oral capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score | Mean change from baseline (BL) in the sum of Parts 1, 3 and 4 of the Unified Dyskinesia Rating Scale (UdysRS), in the ON state. The UDysRS comprises 2 primary sections i.e. Historical [Part 1 (ON-Dyskinesia) and Part 2 (OFF-Dystonia)] and Objective [Part 3 (Impairment) and Part 4 (Disability)] assessment. ON-Dyskinesia are choreic and dystonic movements that occur when the Parkinson's disease (PD) medicine is working. Lower UDysRS values mean better patient outcome i.e. less dyskinesia. The UDysRS score for this study is calculated as sum of the parts, with scores of 0-44 for Part 1, 0-28 for Part 3 and 0-16 for Part 4. | Baseline; Visit 7 (at Week 16) planned. Since the study was terminated early due to the COVID-19 pandemic, analysis of the primary endpoint was done at Visit 5 (Week 8/10) in those patients who were on study drug at this visit. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Levodopa, Dyskinesia