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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.
 
ClinicalTrials.gov Identifier: NCT03922711
Recruitment Status : Terminated (COVID-19)
First Posted : April 22, 2019
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Prilenia

Study Description
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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

Study Design
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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 : March 26, 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

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pridopidine Dose 1
Dose 1 (oral capsule) for 12 weeks following 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 4 week dosage regimen titration period
 Drug: Pridopidine
Oral capsule
Placebo Comparator: Placebo
Matching placebo (oral capsule) for 16 weeks
 Drug: Placebo
Oral capsule


Outcome Measures
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Primary Outcome Measures :
  1. Change in levodopa-induced dyskinesia [ Time Frame: Baseline and Week 16 ]
    Mean change in the sum of Parts 1, 3 and 4 of the Unified Dyskinesia Rating Scale (UdysRS)


Eligibility Criteria
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Information from the National Library of Medicine

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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
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.

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03922711


Locations
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Sponsors and Collaborators
Prilenia
Investigators
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Study Director: Yael Cohen Prilenia
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prilenia
ClinicalTrials.gov Identifier: NCT03922711    
Other Study ID Numbers: PL101-LID201
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: May 2020
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:
Levodopa
Dyskinesia
Additional relevant MeSH terms:
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Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations