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

Prilenia

Status and phase: Terminated; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: Placebo; Drug: Pridopidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03922711

PL101-LID201

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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23 participants in 3 patient groups, including a placebo group

Pridopidine Dose 1

Experimental group

Description:

Dose 1 (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period

Treatment:

Drug: Placebo

Drug: Pridopidine

Pridopidine Dose 2

Experimental group

Description:

Dose 2 for (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period

Treatment:

Drug: Pridopidine

Placebo

Placebo Comparator group

Description:

Matching placebo (oral capsule) for 16 weeks

Treatment:

Drug: Placebo