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

NCT03922711 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: PL101-LID201
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 33

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.

Conditions

Parkinson Disease

Keywords

Levodopa; Dyskinesia

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

Pridopidine Dose 1

EXPERIMENTAL

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

Drug: Pridopidine; Drug: Placebo

Pridopidine Dose 2

EXPERIMENTAL

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

Drug: Pridopidine

Placebo

PLACEBO COMPARATOR

Matching placebo (oral capsule) for 16 weeks

Drug: Placebo

Interventions

Pridopidine DRUG

Oral capsule

Pridopidine Dose 1; Pridopidine Dose 2

Placebo DRUG

Oral capsule

Placebo; Pridopidine Dose 1

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prilenia: lead

Study Sites (33)

Prilenia Investigational Site (Site 117)

Birmingham, Alabama, 35233, United States

Location

Prilenia Investigational Site (Site 144)

Phoenix, Arizona, 85004, United States

Location

Prilenia Investigational Site (Site 111)

Phoenix, Arizona, 85013, United States

Location

Prilenia Investigational Site (Site 115)

Scottsdale, Arizona, 85259, United States

Location

Prilenia Investigational Site (Site 106)

Fountain Valley, California, 92708, United States

Location

Prilenia Investigational Site (Site 109)

Irvine, California, 92697, United States

Location

Prilenia Investigational Site (Site 105)

Pasadena, California, 91105, United States

Location

Prilenia Investigational Site (Stie 142)

Torrance, California, 90502, United States

Location

Prilenia Investigational Site (Site 136)

Aurora, Colorado, 80045, United States

Location

Prilenia Investigational Site (Site 135)

Englewood, Colorado, 80113, United States

Location

Prilenia Investigational Site (Site 118)

Boca Raton, Florida, 33431, United States

Location

Prilenia Investigational Site (Site 131)

Maitland, Florida, 32751, United States

Location

Prilenia Investigational Site (Site 122)

Sunrise, Florida, 33351, United States

Location

Prilenia Investigational Site (Site 116)

Tampa, Florida, 33612, United States

Location

Prilenia Investigational Site (Site 138)

Atlanta, Georgia, 30329, United States

Location

Prilenia Investigational Site (Stie 123)

Augusta, Georgia, 30912, United States

Location

Prilenia Investigational Site (Site 107)

Iowa City, Iowa, 52242, United States

Location

Prilenia Investigational Site (Site 102)

Kansas City, Kansas, 66160, United States

Location

Prilenia Investigational Site (Site 126)

Omaha, Nebraska, 68198, United States

Location

Prilenia Investigational Site (Site 141)

New Brunswick, New Jersey, 08901, United States

Location

Prilenia Investigational Site (Site 128)

Amherst, New York, 14226, United States

Location

Prilenia Investigational Site (Site 147)

New York, New York, 10029, United States

Location

Prilenia Investigational Site (Site 101)

Raleigh, North Carolina, 27607, United States

Location

Prilenia Investigational Site (Site 127)

Raleigh, North Carolina, 27612, United States

Location

Prilenia Investigational Site (Site 149)

Dayton, Ohio, 45459, United States

Location

Prilenia Investigational Site (Site 139)

Tulsa, Oklahoma, 74136, United States

Location

Prilenia Investigational Site (Site 114)

Philadelphia, Pennsylvania, 19107, United States

Location

Prilenia Investigational Site (Site 146)

Willow Grove, Pennsylvania, 19090, United States

Location

Prilenia Investigational Site (Site 119)

Providence, Rhode Island, 02903, United States

Location

Prilenia Investigational Site (Site 120)

Houston, Texas, 77030, United States

Location

Prilenia Investigational Site (Site 121)

Houston, Texas, 77030, United States

Location

Prilenia Investigational Site (Site 129)

San Antonio, Texas, 78230, United States

Location

Prilenia Investigational Site (Site 103)

Kirkland, Washington, 98034, United States

Location

Related Publications (1)

• 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.

  PMID: 31356217 DERIVED

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Parkinson Disease; Dyskinesias

Interventions

pridopidine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was terminated early due to the COVID-19 pandemic.

Results Point of Contact

• Title: Prilenia
• Organization: Prilenia

info@prilenia.com

+972 775558

Study Officials

• Yael Cohen

  Prilenia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 22, 2019
• Study Start: May 22, 2019
• Primary Completion: July 22, 2020
• Study Completion: July 22, 2020
• Last Updated: July 1, 2022
• Results First Posted: July 1, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (33)