A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease
NCT ID: NCT04154072
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
255 participants
INTERVENTIONAL
2020-02-27
2023-02-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NLY01 (2.5 mg)
NLY01 2.5 mg injection
NLY01
exenatide and polyethylene glycol (PEG)
NLY01 (5.0 mg)
NLY01 5.0 mg injection
NLY01
exenatide and polyethylene glycol (PEG)
Vehicle
inactive drug, injection
Vehicle
Saline (Sodium Chloride)
Interventions
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NLY01
exenatide and polyethylene glycol (PEG)
Vehicle
Saline (Sodium Chloride)
Eligibility Criteria
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Inclusion 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
* 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
30 Years
80 Years
ALL
No
Sponsors
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Neuraly, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dan Lee
Role: STUDY_DIRECTOR
Neuraly, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
St. Joseph's Hospital and Medical Center - Barrow Neurological Institute
Phoenix, Arizona, United States
Movement Disorders Center
Scottsdale, Arizona, United States
Mayo Clinic Arizona, Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of California, Irvine
Irvine, California, United States
Keck School of Medicine of USC/University of Southern California
Los Angeles, California, United States
University of California, Los Angeles, Center for Neurotherapeutics
Los Angeles, California, United States
SC3 Research
Pasadena, California, United States
University of California Davis Health
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado
Denver, Colorado, United States
Rocky Mountain Movement Disorder Center
Englewood, Colorado, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Parkinson's Disease and Movement Disorder Center
Boca Raton, Florida, United States
Nova Clinical Research
Bradenton, Florida, United States
University of Florida
Gainesville, Florida, United States
Infinity Clinical Research
Hollywood, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Visionary Investigators Network
Miami, Florida, United States
University of Miami
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
University of South Florida
Tampa, Florida, United States
Charter Research
Winter Park, Florida, United States
Augusta University
Augusta, Georgia, United States
NeuroStudies
Decatur, Georgia, United States
Northwestern Medical Group Neurology Clinic
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
SIU Medicine
Springfield, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Maryland, Neurology Ambulatory Center, Maryland Parkinson's Disease and Movement Disorder Center
Baltimore, Maryland, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital Clinical Trials Pharmacy
Boston, Massachusetts, United States
Boston University Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Struthers Parkinson's Center
Golden Valley, Minnesota, United States
University of Minnesota Delaware Clinical Research Unit
Minneapolis, Minnesota, United States
Neurology Specialists of Monmouth County
West Long Branch, New Jersey, United States
NYU Langone Medical Center, The Marlene and Paolo Fresco Institute for Parkinson's and Movement Disorders
New York, New York, United States
Neurological Institute, Columbia University Medical Center
New York, New York, United States
UNC CTRC
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Raleigh Neurology
Raleigh, North Carolina, United States
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University of Toledo, Gardner-McMaster Parkinson Center
Toledo, Ohio, United States
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Baylor College of Medicine
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Booth Gardner Parkinson's Care Center
Kirkland, Washington, United States
Froedtert Hospital
Milwaukee, Wisconsin, United States
Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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References
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McGarry A, Rosanbalm S, Leinonen M, Olanow CW, To D, Bell A, Lee D, Chang J, Dubow J, Dhall R, Burdick D, Parashos S, Feuerstein J, Quinn J, Pahwa R, Afshari M, Ramirez-Zamora A, Chou K, Tarakad A, Luca C, Klos K, Bordelon Y, St Hiliare MH, Shprecher D, Lee S, Dawson TM, Roschke V, Kieburtz K. Safety, tolerability, and efficacy of NLY01 in early untreated Parkinson's disease: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2024 Jan;23(1):37-45. doi: 10.1016/S1474-4422(23)00378-2.
Other Identifiers
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NLY01-PD-1
Identifier Type: -
Identifier Source: org_study_id
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