Clinical trial NCT03922711: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Levodopa
Dyskinesia
Lead sponsor: Prilenia
Sponsor class: INDUSTRY
First posted: 2019-04-22
Enrollment: 23
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in Levodopa-induced Dyskinesia as Measured by UDysRS Score
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Prilenia Investigational Site (Site 117)
state: Alabama
city: Phoenix
country: United States
facility: Prilenia Investigational Site (Site 144)
state: Arizona
city: Phoenix
country: United States
facility: Prilenia Investigational Site (Site 111)
state: Arizona
city: Scottsdale
country: United States
facility: Prilenia Investigational Site (Site 115)
state: Arizona
city: Fountain Valley
country: United States
facility: Prilenia Investigational Site (Site 106)
state: California
city: Irvine
country: United States
facility: Prilenia Investigational Site (Site 109)
state: California
city: Pasadena
country: United States
facility: Prilenia Investigational Site (Site 105)
state: California
city: Torrance
country: United States
facility: Prilenia Investigational Site (Stie 142)
state: California
city: Aurora
country: United States
facility: Prilenia Investigational Site (Site 136)
state: Colorado
city: Englewood
country: United States
facility: Prilenia Investigational Site (Site 135)
state: Colorado
city: Boca Raton
country: United States
facility: Prilenia Investigational Site (Site 118)
state: Florida
city: Maitland
country: United States
facility: Prilenia Investigational Site (Site 131)
state: Florida
city: Sunrise
country: United States
facility: Prilenia Investigational Site (Site 122)
state: Florida
city: Tampa
country: United States
facility: Prilenia Investigational Site (Site 116)
state: Florida
city: Atlanta
country: United States
facility: Prilenia Investigational Site (Site 138)
state: Georgia
city: Augusta
country: United States
facility: Prilenia Investigational Site (Stie 123)
state: Georgia
city: Iowa City
country: United States
facility: Prilenia Investigational Site (Site 107)
state: Iowa
city: Kansas City
country: United States
facility: Prilenia Investigational Site (Site 102)
state: Kansas
city: Omaha
country: United States
facility: Prilenia Investigational Site (Site 126)
state: Nebraska
city: New Brunswick
country: United States
facility: Prilenia Investigational Site (Site 141)
state: New Jersey
city: Amherst
country: United States
facility: Prilenia Investigational Site (Site 128)
state: New York
city: New York
country: United States
facility: Prilenia Investigational Site (Site 147)
state: New York
city: Raleigh
country: United States
facility: Prilenia Investigational Site (Site 101)
state: North Carolina
city: Raleigh
country: United States
facility: Prilenia Investigational Site (Site 127)
state: North Carolina
city: Dayton
country: United States
facility: Prilenia Investigational Site (Site 149)
state: Ohio
city: Tulsa
country: United States
facility: Prilenia Investigational Site (Site 139)
state: Oklahoma
city: Philadelphia
country: United States
facility: Prilenia Investigational Site (Site 114)
state: Pennsylvania
city: Willow Grove
country: United States
facility: Prilenia Investigational Site (Site 146)
state: Pennsylvania
city: Providence
country: United States
facility: Prilenia Investigational Site (Site 119)
state: Rhode Island
city: Houston
country: United States
facility: Prilenia Investigational Site (Site 120)
state: Texas
city: Houston
country: United States
facility: Prilenia Investigational Site (Site 121)
state: Texas
city: San Antonio
country: United States
facility: Prilenia Investigational Site (Site 129)
state: Texas
city: Kirkland
country: United States
facility: Prilenia Investigational Site (Site 103)
state: Washington
Study officials:
affiliation: Prilenia
name: Yael Cohen
role: STUDY_DIRECTOR
References:
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.