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
- Registration Number
- NCT03922711
- Lead Sponsor
- Prilenia
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 23
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pridopidine Dose 2 Pridopidine Dose 2 for (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period Placebo Placebo Matching placebo (oral capsule) for 16 weeks Pridopidine Dose 1 Placebo Dose 1 (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period Pridopidine Dose 1 Pridopidine Dose 1 (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period
- Primary Outcome Measures
Name Time Method Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score 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. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
Prilenia Investigational Site (Site 115)
🇺🇸Scottsdale, Arizona, United States
Prilenia Investigational Site (Site 122)
🇺🇸Sunrise, Florida, United States
Prilenia Investigational Site (Stie 142)
🇺🇸Torrance, California, United States
Prilenia Investigational Site (Site 118)
🇺🇸Boca Raton, Florida, United States
Prilenia Investigational Site (Site 101)
🇺🇸Raleigh, North Carolina, United States
Prilenia Investigational Site (Site 149)
🇺🇸Dayton, Ohio, United States
Prilenia Investigational Site (Site 103)
🇺🇸Kirkland, Washington, United States
Prilenia Investigational Site (Site 120)
🇺🇸Houston, Texas, United States
Prilenia Investigational Site (Site 102)
🇺🇸Kansas City, Kansas, United States
Prilenia Investigational Site (Site 135)
🇺🇸Englewood, Colorado, United States
Prilenia Investigational Site (Site 106)
🇺🇸Fountain Valley, California, United States
Prilenia Investigational Site (Site 109)
🇺🇸Irvine, California, United States
Prilenia Investigational Site (Site 105)
🇺🇸Pasadena, California, United States
Prilenia Investigational Site (Site 131)
🇺🇸Maitland, Florida, United States
Prilenia Investigational Site (Site 138)
🇺🇸Atlanta, Georgia, United States
Prilenia Investigational Site (Site 107)
🇺🇸Iowa City, Iowa, United States
Prilenia Investigational Site (Site 141)
🇺🇸New Brunswick, New Jersey, United States
Prilenia Investigational Site (Site 128)
🇺🇸Amherst, New York, United States
Prilenia Investigational Site (Site 147)
🇺🇸New York, New York, United States
Prilenia Investigational Site (Site 127)
🇺🇸Raleigh, North Carolina, United States
Prilenia Investigational Site (Site 114)
🇺🇸Philadelphia, Pennsylvania, United States
Prilenia Investigational Site (Site 146)
🇺🇸Willow Grove, Pennsylvania, United States
Prilenia Investigational Site (Site 119)
🇺🇸Providence, Rhode Island, United States
Prilenia Investigational Site (Site 121)
🇺🇸Houston, Texas, United States
Prilenia Investigational Site (Stie 123)
🇺🇸Augusta, Georgia, United States
Prilenia Investigational Site (Site 139)
🇺🇸Tulsa, Oklahoma, United States
Prilenia Investigational Site (Site 144)
🇺🇸Phoenix, Arizona, United States
Prilenia Investigational Site (Site 111)
🇺🇸Phoenix, Arizona, United States
Prilenia Investigational Site (Site 129)
🇺🇸San Antonio, Texas, United States
Prilenia Investigational Site (Site 136)
🇺🇸Aurora, Colorado, United States
Prilenia Investigational Site (Site 117)
🇺🇸Birmingham, Alabama, United States
Prilenia Investigational Site (Site 116)
🇺🇸Tampa, Florida, United States
Prilenia Investigational Site (Site 126)
🇺🇸Omaha, Nebraska, United States