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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03922711
Recruitment Status : Terminated (COVID-19)
First Posted : April 22, 2019
Results First Posted : July 1, 2022
Last Update Posted : July 1, 2022
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Pridopidine Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Three-Arm, Parallel-Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine Versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease (gLIDe)
Actual Study Start Date : May 22, 2019
Actual Primary Completion Date : July 22, 2020
Actual Study Completion Date : July 22, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

Arm Intervention/treatment
Experimental: Pridopidine Dose 1
Dose 1 (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period
Drug: Pridopidine
Oral capsule

Drug: Placebo
Oral capsule

Experimental: Pridopidine Dose 2
Dose 2 for (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period
Drug: Pridopidine
Oral capsule

Placebo Comparator: Placebo
Matching placebo (oral capsule) for 16 weeks
Drug: Placebo
Oral capsule

Primary Outcome Measures :
  1. Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03922711

Show Show 33 study locations
Sponsors and Collaborators
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Study Director: Yael Cohen Prilenia
  Study Documents (Full-Text)

Documents provided by Prilenia:
Study Protocol  [PDF] November 19, 2019
Statistical Analysis Plan  [PDF] July 23, 2020

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prilenia Identifier: NCT03922711    
Other Study ID Numbers: PL101-LID201
First Posted: April 22, 2019    Key Record Dates
Results First Posted: July 1, 2022
Last Update Posted: July 1, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prilenia:
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations