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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03922711

Recruitment Status Active, not recruiting

First Posted April 22, 2019

Last update posted August 13, 2020

Study Description

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:Parkinson Disease
  • Intervention/Treatment: Drug: Pridopidine
    Drug: Placebo
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 135 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 2019
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: April 2021
Arms and interventions
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
  • 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
  • Ages Eligible for Study: 30 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
Contacts
Locations
Show 33 Study Locations
Sponsors and Collaborators

Prilenia

Investigators

Study Director: Yael Cohen Prilenia

More Information
  • Responsible Party: Prilenia
  • ClinicalTrials.gov Identifier: NCT03922711 History of Changes
  • Other Study ID Numbers: PL101-LID201
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: August 13, 2020
  • Last Verified: May 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • 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: Parkinson Disease Dyskinesias