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
NCT ID: NCT03922711
Last Updated: 2022-07-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
23 participants
INTERVENTIONAL
2019-05-22
2020-07-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pridopidine Dose 1
Dose 1 (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period
Pridopidine
Oral capsule
Placebo
Oral capsule
Pridopidine Dose 2
Dose 2 for (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period
Pridopidine
Oral capsule
Placebo
Matching placebo (oral capsule) for 16 weeks
Placebo
Oral capsule
Interventions
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Pridopidine
Oral capsule
Placebo
Oral capsule
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
85 Years
ALL
No
Sponsors
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Prilenia
INDUSTRY
Responsible Party
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Principal Investigators
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Yael Cohen
Role: STUDY_DIRECTOR
Prilenia
Locations
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Prilenia Investigational Site (Site 117)
Birmingham, Alabama, United States
Prilenia Investigational Site (Site 144)
Phoenix, Arizona, United States
Prilenia Investigational Site (Site 111)
Phoenix, Arizona, United States
Prilenia Investigational Site (Site 115)
Scottsdale, Arizona, 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 (Stie 142)
Torrance, California, United States
Prilenia Investigational Site (Site 136)
Aurora, Colorado, United States
Prilenia Investigational Site (Site 135)
Englewood, Colorado, United States
Prilenia Investigational Site (Site 118)
Boca Raton, Florida, United States
Prilenia Investigational Site (Site 131)
Maitland, Florida, United States
Prilenia Investigational Site (Site 122)
Sunrise, Florida, United States
Prilenia Investigational Site (Site 116)
Tampa, Florida, United States
Prilenia Investigational Site (Site 138)
Atlanta, Georgia, United States
Prilenia Investigational Site (Stie 123)
Augusta, Georgia, United States
Prilenia Investigational Site (Site 107)
Iowa City, Iowa, United States
Prilenia Investigational Site (Site 102)
Kansas City, Kansas, United States
Prilenia Investigational Site (Site 126)
Omaha, Nebraska, 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 101)
Raleigh, North Carolina, United States
Prilenia Investigational Site (Site 127)
Raleigh, North Carolina, United States
Prilenia Investigational Site (Site 149)
Dayton, Ohio, United States
Prilenia Investigational Site (Site 139)
Tulsa, Oklahoma, 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 120)
Houston, Texas, United States
Prilenia Investigational Site (Site 121)
Houston, Texas, United States
Prilenia Investigational Site (Site 129)
San Antonio, Texas, United States
Prilenia Investigational Site (Site 103)
Kirkland, Washington, United States
Countries
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References
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McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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PL101-LID201
Identifier Type: -
Identifier Source: org_study_id
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