Clinical trial NCT04154072: A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment With NLY01 in Early-stage Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Lead sponsor: Neuraly, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-06
Enrollment: 255
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 2 study designed to assess the safety, tolerability and efficacy of NLY01 in subjects with early untreated Parkinson's disease (PD). Evidence suggests NLY01, a pegylated form of exenatide, may be beneficial in PD and is being developed as a potential treatment for neurodegenerative disorders.


Eligibility criteria: Inclusion Criteria:

* Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic criteria or Movement Disorder Society Research Criteria
* Patients with Parkinson's disease according to protocol specified scale assessments
* DaTscan consistent with diagnosis of Parkinson's Disease
* Men or women 30 to 80 years of age

Exclusion Criteria:

* Diagnosis of secondary or atypical parkinsonism
* Prior use of dopaminergic treatment or MAO-B inhibitors for more than 28 days
* Medical or recreational use of marijuana or THC-containing compounds within 3 months of screening visit
* Pregnant or planning to become pregnant
* Metabolic, surgical, psychiatric or laboratory abnormality that would interfere with study compliance or safety in the judgment of the investigator

Primary outcomes:
measure: Change in Unified Parkinson's Disease Rating Scale in combined score of Parts II and III from baseline to 36 weeks
timeFrame: 36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center - Barrow Neurological Institute
state: Arizona
city: Scottsdale
country: United States
facility: Movement Disorders Center
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona, Mayo Clinic Scottsdale
state: Arizona
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine of USC/University of Southern California
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles, Center for Neurotherapeutics
state: California
city: Pasadena
country: United States
facility: SC3 Research
state: California
city: Sacramento
country: United States
facility: University of California Davis Health
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Englewood
country: United States
facility: Rocky Mountain Movement Disorder Center
state: Colorado
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorder Center
state: Florida
city: Bradenton
country: United States
facility: Nova Clinical Research
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Hollywood
country: United States
facility: Infinity Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Miami
country: United States
facility: Visionary Investigators Network
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Winter Park
country: United States
facility: Charter Research
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Decatur
country: United States
facility: NeuroStudies
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medical Group Neurology Clinic
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Springfield
country: United States
facility: SIU Medicine
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland, Neurology Ambulatory Center, Maryland Parkinson's Disease and Movement Disorder Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital Clinical Trials Pharmacy
state: Massachusetts
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
city: Farmington Hills
country: United States
facility: Quest Research Institute
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford West Bloomfield Hospital
state: Michigan
city: Golden Valley
country: United States
facility: Struthers Parkinson's Center
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Delaware Clinical Research Unit
state: Minnesota
city: West Long Branch
country: United States
facility: Neurology Specialists of Monmouth County
state: New Jersey
city: New York
country: United States
facility: NYU Langone Medical Center, The Marlene and Paolo Fresco Institute for Parkinson's and Movement Disorders
state: New York
city: New York
country: United States
facility: Neurological Institute, Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC CTRC
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Sciences
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Toledo
country: United States
facility: University of Toledo, Gardner-McMaster Parkinson Center
state: Ohio
city: Tulsa
country: United States
facility: The Movement Disorder Clinic of Oklahoma
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Kirkland
country: United States
facility: Booth Gardner Parkinson's Care Center
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: Neuraly, Inc.
name: Dan Lee
role: STUDY_DIRECTOR
References: