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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

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ClinicalTrials.gov Identifier: NCT03922711
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Prilenia Therapeutics Development Ltd.

Brief Summary:
This is a multicenter, randomized, double-blind, placebo-controlled, three-arm parallel group 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)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 14-week, 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
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 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 two 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 week dosage regimen titration period
Drug: Pridopidine
Oral capsule

Placebo Comparator: Placebo
Matching placebo (oral capsule) for 14 weeks
Drug: Placebo
Oral capsule




Primary Outcome Measures :
  1. Change in levodopa-induced dyskinesia [ Time Frame: Baseline and Week 14 ]
    Mean change in the sum of Parts 1, 3 and 4 of the Unified Dyskinesia Rating Scale (UdysRS)



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
Criteria

Inclusion Criteria:

  • Provides signed informed consent form.
  • Has clinical diagnosis of Parkinson's Disease (PD).
  • Has mild-to-moderate Levodopa-induced dyskinesia (LID).
  • Patient and/or study partner must demonstrate ability to keep accurate home diary of PD symptoms.
  • Has stable anti-PD treatment 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 ClinicalTrials.gov identifier (NCT number): NCT03922711


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information please email: ClinicalTrials@prilenia.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
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United States, California
Prilenia Investigational Site (Site 001) Recruiting
Fountain Valley, California, United States, 92708
Contact: Site 001       ClinicalTrials@prilenia.com   
United States, Florida
Prilenia Investigational Site (Site 002) Recruiting
Sunrise, Florida, United States, 33351
Contact: Site 0002       ClinicalTrials@prilenia.com   
Sponsors and Collaborators
Prilenia Therapeutics Development Ltd.
Investigators
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Study Director: Yael Cohen Prilenia Therapeutics

Additional Information:
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Responsible Party: Prilenia Therapeutics Development Ltd.
ClinicalTrials.gov Identifier: NCT03922711     History of Changes
Other Study ID Numbers: PL101-LID201
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
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 Therapeutics Development Ltd.:
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
Signs and Symptoms
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs