A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease
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
1 other identifier
interventional
255
2 countries
61
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 parkinson-disease
Started Feb 2020
Typical duration for phase_2 parkinson-disease
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2019
CompletedFirst Posted
Study publicly available on registry
November 6, 2019
CompletedStudy Start
First participant enrolled
February 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2023
CompletedSeptember 19, 2024
March 1, 2024
3 years
November 4, 2019
September 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Unified Parkinson's Disease Rating Scale in combined score of Parts II and III from baseline to 36 weeks
This is the Unified Parkinson's Disease Rating Scale assessment (MDS-UPDRS). The investigator will assess II and III components of the Unified Parkinson's Disease Rating Scale. The Unified Parkinson's Disease Rating Scale Part II assesses motor aspects of experiences of daily living. The Unified Parkinson's Disease Rating Scale Part III assesses motor signs of Parkinson's Disease. The Unified Parkinson's Disease Rating Scale is a widely used assessment to quantify the signs and symptoms of Parkinson's Disease. Each subscale has 0-4 ratings, where 0=normal, 1=slight, 2=mild, 3=moderate and 4=severe. The scale is completed by the investigator and scores are derived from clinician and subject input to allow the assessment of symptomatic worsening and improvement.
36 weeks
Study Arms (3)
NLY01 (2.5 mg)
ACTIVE COMPARATORNLY01 2.5 mg injection
NLY01 (5.0 mg)
ACTIVE COMPARATORNLY01 5.0 mg injection
Vehicle
PLACEBO COMPARATORinactive drug, injection
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuraly, Inc.lead
Study Sites (61)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
St. Joseph's Hospital and Medical Center - Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
Movement Disorders Center
Scottsdale, Arizona, 85258, United States
Mayo Clinic Arizona, Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
University of California, Irvine
Irvine, California, 92697, United States
Keck School of Medicine of USC/University of Southern California
Los Angeles, California, 90033, United States
University of California, Los Angeles, Center for Neurotherapeutics
Los Angeles, California, 90095, United States
SC3 Research
Pasadena, California, 91105, United States
University of California Davis Health
Sacramento, California, 95816, United States
University of California, San Francisco
San Francisco, California, 94143, United States
University of Colorado
Denver, Colorado, 80204, United States
Rocky Mountain Movement Disorder Center
Englewood, Colorado, 80113, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Parkinson's Disease and Movement Disorder Center
Boca Raton, Florida, 33486, United States
Nova Clinical Research
Bradenton, Florida, 34209, United States
University of Florida
Gainesville, Florida, 32608, United States
Infinity Clinical Research
Hollywood, Florida, 33024, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Visionary Investigators Network
Miami, Florida, 33133, United States
University of Miami
Miami, Florida, 33136, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
University of South Florida
Tampa, Florida, 33613, United States
Charter Research
Winter Park, Florida, 32159, United States
Augusta University
Augusta, Georgia, 30912, United States
NeuroStudies
Decatur, Georgia, 30033, United States
Northwestern Medical Group Neurology Clinic
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
SIU Medicine
Springfield, Illinois, 62702, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Maryland, Neurology Ambulatory Center, Maryland Parkinson's Disease and Movement Disorder Center
Baltimore, Maryland, 21201, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital Clinical Trials Pharmacy
Boston, Massachusetts, 02114, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
Quest Research Institute
Farmington Hills, Michigan, 48334, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Struthers Parkinson's Center
Golden Valley, Minnesota, 55427, United States
University of Minnesota Delaware Clinical Research Unit
Minneapolis, Minnesota, 55414, United States
Neurology Specialists of Monmouth County
West Long Branch, New Jersey, 07764, United States
NYU Langone Medical Center, The Marlene and Paolo Fresco Institute for Parkinson's and Movement Disorders
New York, New York, 10017, United States
Neurological Institute, Columbia University Medical Center
New York, New York, 10032, United States
UNC CTRC
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Raleigh Neurology
Raleigh, North Carolina, 27607, United States
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, 27157, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
University of Toledo, Gardner-McMaster Parkinson Center
Toledo, Ohio, 43614, United States
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, 74136, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19107, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Booth Gardner Parkinson's Care Center
Kirkland, Washington, 98034, United States
Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Related Publications (1)
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.
PMID: 38101901DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dan Lee
Neuraly, Inc.
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
November 4, 2019
First Posted
November 6, 2019
Study Start
February 27, 2020
Primary Completion
February 14, 2023
Study Completion
February 14, 2023
Last Updated
September 19, 2024
Record last verified: 2024-03