search
Back to results

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

Primary Purpose

Parkinson Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pridopidine
Placebo
Sponsored by
Prilenia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Levodopa, Dyskinesia

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Prilenia Investigational Site (Site 117)
  • Prilenia Investigational Site (Site 144)
  • Prilenia Investigational Site (Site 111)
  • Prilenia Investigational Site (Site 115)
  • Prilenia Investigational Site (Site 106)
  • Prilenia Investigational Site (Site 109)
  • Prilenia Investigational Site (Site 105)
  • Prilenia Investigational Site (Stie 142)
  • Prilenia Investigational Site (Site 136)
  • Prilenia Investigational Site (Site 135)
  • Prilenia Investigational Site (Site 118)
  • Prilenia Investigational Site (Site 131)
  • Prilenia Investigational Site (Site 122)
  • Prilenia Investigational Site (Site 116)
  • Prilenia Investigational Site (Site 138)
  • Prilenia Investigational Site (Stie 123)
  • Prilenia Investigational Site (Site 107)
  • Prilenia Investigational Site (Site 102)
  • Prilenia Investigational Site (Site 126)
  • Prilenia Investigational Site (Site 141)
  • Prilenia Investigational Site (Site 128)
  • Prilenia Investigational Site (Site 147)
  • Prilenia Investigational Site (Site 101)
  • Prilenia Investigational Site (Site 127)
  • Prilenia Investigational Site (Site 149)
  • Prilenia Investigational Site (Site 139)
  • Prilenia Investigational Site (Site 114)
  • Prilenia Investigational Site (Site 146)
  • Prilenia Investigational Site (Site 119)
  • Prilenia Investigational Site (Site 120)
  • Prilenia Investigational Site (Site 121)
  • Prilenia Investigational Site (Site 129)
  • Prilenia Investigational Site (Site 103)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Pridopidine Dose 1

Pridopidine Dose 2

Placebo

Arm Description

Dose 1 (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period

Dose 2 for (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period

Matching placebo (oral capsule) for 16 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 17, 2019
Last Updated
June 7, 2022
Sponsor
Prilenia
search

1. Study Identification

Unique Protocol Identification Number
NCT03922711
Brief Title
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
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID-19
Study Start Date
May 22, 2019 (Actual)
Primary Completion Date
July 22, 2020 (Actual)
Study Completion Date
July 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prilenia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Levodopa, Dyskinesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pridopidine Dose 1
Arm Type
Experimental
Arm Description
Dose 1 (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period
Arm Title
Pridopidine Dose 2
Arm Type
Experimental
Arm Description
Dose 2 for (oral capsule) for 12 weeks following 2 or 4 week dosage regimen titration period
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo (oral capsule) for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Pridopidine
Intervention Description
Oral capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral capsule
Primary Outcome Measure Information:
Title
Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yael Cohen
Organizational Affiliation
Prilenia
Official's Role
Study Director
Facility Information:
Facility Name
Prilenia Investigational Site (Site 117)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Prilenia Investigational Site (Site 144)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Prilenia Investigational Site (Site 111)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Prilenia Investigational Site (Site 115)
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Prilenia Investigational Site (Site 106)
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Prilenia Investigational Site (Site 109)
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Prilenia Investigational Site (Site 105)
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Prilenia Investigational Site (Stie 142)
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Prilenia Investigational Site (Site 136)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Prilenia Investigational Site (Site 135)
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Prilenia Investigational Site (Site 118)
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Prilenia Investigational Site (Site 131)
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Prilenia Investigational Site (Site 122)
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Prilenia Investigational Site (Site 116)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Prilenia Investigational Site (Site 138)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Prilenia Investigational Site (Stie 123)
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Prilenia Investigational Site (Site 107)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Prilenia Investigational Site (Site 102)
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Prilenia Investigational Site (Site 126)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Prilenia Investigational Site (Site 141)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Prilenia Investigational Site (Site 128)
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Prilenia Investigational Site (Site 147)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Prilenia Investigational Site (Site 101)
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Prilenia Investigational Site (Site 127)
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Prilenia Investigational Site (Site 149)
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Prilenia Investigational Site (Site 139)
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Prilenia Investigational Site (Site 114)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Prilenia Investigational Site (Site 146)
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Prilenia Investigational Site (Site 119)
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Prilenia Investigational Site (Site 120)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Prilenia Investigational Site (Site 121)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Prilenia Investigational Site (Site 129)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
Prilenia Investigational Site (Site 103)
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31356217
Citation
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.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/Recalls
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

We'll reach out to this number within 24 hrs