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.
– 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
– 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.
– 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
– History of certain cancers within 5 years prior to screening.
– Significant cardiac event within 12 weeks prior to Baseline or history of certain
– 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 with any investigational product within 30 days of screening or plans to
participate in another clinical study assessing any investigational product during the
Other protocol-defined inclusion/exclusion criteria could apply.
- Prilenia Investigational Site (Site 106), Fountain Valley, California, United States, 92708
- Prilenia Investigational Site (Site 109), Irvine, California, United States, 92697
- Prilenia Investigational Site (Site 105), Pasadena, California, United States, 91105
- Prilenia Investigational Site (Stie 142), Torrance, California, United States, 90502