A Randomized, Double-Blind, Placebo-Controlled, Phase IIa, Parallel Group, Two Cohort Study to Define the Safety, Tolerability, Clinical and Exploratory Biological Activity of the Chronic Administration of Nilotinib in Participants With Parkinson's Disease

Status: Completed
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study will assess the safety and tolerability of daily oral administration of nilotinib (150-300mg once daily) in Parkinson's Disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 79
Healthy Volunteers: No
View:

• Idiopathic PD based on the UK Brain Bank diagnostic criteria.

• Any race and either gender, age 40-79

• Able to read and understand English with the capacity to provide voluntary informed consent by signing the informed consent form (ICF)

• Willing to comply with all study procedures including multiple lumbar punctures (LP)

• Must be on a stable regimen of central nervous system acting medications (if applicable) for at least 30 days prior to the baseline visit (e.g., benzodiazepines, antidepressants, hypnotics)

• 6a. Diagnosis of PD duration > 5 year 7a. Hoehn & Yahr scale (H&Y) stage > 2 and < 4 in the ON state 8a. Must be on a stable regimen of PD medications, that includes levodopa, for at least 30 days prior to the screening visit

• a. Treatment with monoamine oxidase B (MAO-B) inhibitors will be allowed provided the dose has been stable for 60 days prior to baseline

• 6b. Diagnosis of PD duration < 3 years 7b. H&Y stage ≤ 2 8b. Participants who are currently NOT receiving symptomatic therapy (ST) (levodopa,dopamine agonists and monoamine oxidase B (MAO-B) inhibitors) and NOT projected to require ST for at least 3 months from enrollment.

• a. Treatment with amantadine or an anticholinergic agent will be allowed provided the dose has been stable for 30 days prior to screening and will remain stable for the duration of the study

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Arizona
Barrow Neurological Institute
Sun City
California
University of California Davis
Sacramento
Colorado
University of Colorado at Denver
Aurora
Florida
University of Florida
Gainesville
University of South Florida
Tampa
Illinois
Rush University Medical Center
Chicago
Massachusetts
Massachusetts General Hospital
Boston
Maryland
John Hopkins University
Baltimore
Michigan
University of Michigan
Ann Arbor
Michigan State University
East Lansing
North Carolina
Duke University Medical Center
Durham
Nevada
Cleveland Clinic - Las Vegas
Las Vegas
New York
Albany Medical College
Albany
Beth Israel Medical Center
New York
Ohio
University of Cincinnati
Cincinnati
Cleveland Clinic
Cleveland
Oregon
Oregon Health and Science University
Portland
Pennsylvania
University of Pennsylvania
Philadelphia
South Carolina
Medical University of South Carolina
Charleston
Texas
Baylor College of Medicine
Houston
Virginia
University of Virginia
Charlottesville
Washington
Inland Northwest Research
Spokane
Wisconsin
Medical College of Wisconsin
Milwaukee
Time Frame
Start Date: October 16, 2017
Completion Date: September 28, 2019
Participants
Target number of participants: 76
Treatments
Active Comparator: Cohort 1
Moderate to Advanced PD Population Randomized 1:1:1
Active Comparator: Cohort 2
Early/de novo Randomized 2:1
Sponsors
Collaborators: Michael J. Fox Foundation for Parkinson's Research, University of Rochester, University of Iowa
Leads: Northwestern University

This content was sourced from clinicaltrials.gov

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