DRUG
NLY01
exenatide and polyethylene glycol (PEG)
A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease
Status
Completed
Phase
Phase 2
Enrollment
255
Locations
61
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Vehicle
Saline (Sodium Chloride)
Timeline
From registration to results.
First posted
Nov 6, 2019
Study start
Feb 27, 2020
Primary completion
Feb 14, 2023
Study completion
Feb 14, 2023
Results posted
Not reported
Registry updated
Sep 19, 2024
Outcomes
What the study measures.
Primary outcomes
Change in Unified Parkinson's Disease Rating Scale in combined score of Parts II and III from baseline to 36 weeks
Time frame · 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.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 30 Years
- Maximum age
- 80 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
61 registered sites.
Canada · United States. Showing up to 24 locations stored in the fast local snapshot.
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
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.