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

Parkinson Disease Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03922711
• Other study ID #: PL101-LID201
• Status: Terminated
• Phase: Phase 2
• Start date: May 22, 2019
• Est. completion date: July 22, 2020

Study information

• Verified date: April 2022
• Source: Prilenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: July 22, 2020
• Est. primary completion date: July 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease

Intervention

Drug:
• Pridopidine
Oral capsule
• Placebo
Oral capsule

Locations

Country	Name	City	State
United States	Prilenia Investigational Site (Site 128)	Amherst	New York
United States	Prilenia Investigational Site (Site 138)	Atlanta	Georgia
United States	Prilenia Investigational Site (Stie 123)	Augusta	Georgia
United States	Prilenia Investigational Site (Site 136)	Aurora	Colorado
United States	Prilenia Investigational Site (Site 117)	Birmingham	Alabama
United States	Prilenia Investigational Site (Site 118)	Boca Raton	Florida
United States	Prilenia Investigational Site (Site 149)	Dayton	Ohio
United States	Prilenia Investigational Site (Site 135)	Englewood	Colorado
United States	Prilenia Investigational Site (Site 106)	Fountain Valley	California
United States	Prilenia Investigational Site (Site 120)	Houston	Texas
United States	Prilenia Investigational Site (Site 121)	Houston	Texas
United States	Prilenia Investigational Site (Site 107)	Iowa City	Iowa
United States	Prilenia Investigational Site (Site 109)	Irvine	California
United States	Prilenia Investigational Site (Site 102)	Kansas City	Kansas
United States	Prilenia Investigational Site (Site 103)	Kirkland	Washington
United States	Prilenia Investigational Site (Site 131)	Maitland	Florida
United States	Prilenia Investigational Site (Site 141)	New Brunswick	New Jersey
United States	Prilenia Investigational Site (Site 147)	New York	New York
United States	Prilenia Investigational Site (Site 126)	Omaha	Nebraska
United States	Prilenia Investigational Site (Site 105)	Pasadena	California
United States	Prilenia Investigational Site (Site 114)	Philadelphia	Pennsylvania
United States	Prilenia Investigational Site (Site 111)	Phoenix	Arizona
United States	Prilenia Investigational Site (Site 144)	Phoenix	Arizona
United States	Prilenia Investigational Site (Site 119)	Providence	Rhode Island
United States	Prilenia Investigational Site (Site 101)	Raleigh	North Carolina
United States	Prilenia Investigational Site (Site 127)	Raleigh	North Carolina
United States	Prilenia Investigational Site (Site 129)	San Antonio	Texas
United States	Prilenia Investigational Site (Site 115)	Scottsdale	Arizona
United States	Prilenia Investigational Site (Site 122)	Sunrise	Florida
United States	Prilenia Investigational Site (Site 116)	Tampa	Florida
United States	Prilenia Investigational Site (Stie 142)	Torrance	California
United States	Prilenia Investigational Site (Site 139)	Tulsa	Oklahoma
United States	Prilenia Investigational Site (Site 146)	Willow Grove	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Prilenia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   FDA Safety Alerts and Recalls