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

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)

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.

Study Overview

• Status: Terminated
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Placebo; Drug: Pridopidine

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Prilenia Investigational Site (Site 117)
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Prilenia Investigational Site (Site 144)
    • Phoenix, Arizona, United States, 85013
      • Prilenia Investigational Site (Site 111)
    • Scottsdale, Arizona, United States, 85259
      • Prilenia Investigational Site (Site 115)
  • California
    • Fountain Valley, California, United States, 92708
      • Prilenia Investigational Site (Site 106)
    • Irvine, California, United States, 92697
      • Prilenia Investigational Site (Site 109)
    • Pasadena, California, United States, 91105
      • Prilenia Investigational Site (Site 105)
    • Torrance, California, United States, 90502
      • Prilenia Investigational Site (Stie 142)
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Prilenia Investigational Site (Site 136)
    • Englewood, Colorado, United States, 80113
      • Prilenia Investigational Site (Site 135)
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Prilenia Investigational Site (Site 118)
    • Maitland, Florida, United States, 32751
      • Prilenia Investigational Site (Site 131)
    • Sunrise, Florida, United States, 33351
      • Prilenia Investigational Site (Site 122)
    • Tampa, Florida, United States, 33612
      • Prilenia Investigational Site (Site 116)
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Prilenia Investigational Site (Site 138)
    • Augusta, Georgia, United States, 30912
      • Prilenia Investigational Site (Stie 123)
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Prilenia Investigational Site (Site 107)
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Prilenia Investigational Site (Site 102)
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Prilenia Investigational Site (Site 126)
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Prilenia Investigational Site (Site 141)
  • New York
    • Amherst, New York, United States, 14226
      • Prilenia Investigational Site (Site 128)
    • New York, New York, United States, 10029
      • Prilenia Investigational Site (Site 147)
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Prilenia Investigational Site (Site 101)
    • Raleigh, North Carolina, United States, 27612
      • Prilenia Investigational Site (Site 127)
  • Ohio
    • Dayton, Ohio, United States, 45459
      • Prilenia Investigational Site (Site 149)
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Prilenia Investigational Site (Site 139)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Prilenia Investigational Site (Site 114)
    • Willow Grove, Pennsylvania, United States, 19090
      • Prilenia Investigational Site (Site 146)
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Prilenia Investigational Site (Site 119)
  • Texas
    • Houston, Texas, United States, 77030
      • Prilenia Investigational Site (Site 120)
    • Houston, Texas, United States, 77030
      • Prilenia Investigational Site (Site 121)
    • San Antonio, Texas, United States, 78230
      • Prilenia Investigational Site (Site 129)
  • Washington
    • Kirkland, Washington, United States, 98034
      • Prilenia Investigational Site (Site 103)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pridopidine Dose 1; Dose 1 (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period	Drug: Placebo; Oral capsule; Drug: Pridopidine; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score	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.	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.

Collaborators and Investigators

• Sponsor: Prilenia
• Investigators: Study Director: Yael Cohen, Prilenia

Publications and helpful links

General Publications

• 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.

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2019
• Primary Completion (ACTUAL): July 22, 2020
• Study Completion (ACTUAL): July 22, 2020

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (ACTUAL): April 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Levodopa; Dyskinesia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Dyskinesias
• Other Study ID Numbers: PL101-LID201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No