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

• Status: Terminated
• Trial end date: 2020-07-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prilenia; Prilenia Therapeutics Development Ltd.
• Treatments: Levodopa

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.