A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease
- Registration Number
- NCT04154072
- Lead Sponsor
- Neuraly, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 255
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NLY01 (2.5 mg) NLY01 NLY01 2.5 mg injection Vehicle Vehicle inactive drug, injection NLY01 (5.0 mg) NLY01 NLY01 5.0 mg injection
- Primary Outcome Measures
Name Time Method Change in Unified Parkinson's Disease Rating Scale in combined score of Parts II and III from baseline to 36 weeks 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (61)
Augusta University
🇺🇸Augusta, Georgia, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
University of California, Los Angeles, Center for Neurotherapeutics
🇺🇸Los Angeles, California, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Visionary Investigators Network
🇺🇸Miami, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Northwestern Medical Group Neurology Clinic
🇺🇸Chicago, Illinois, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
St. Joseph's Hospital and Medical Center - Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
University of Colorado
🇺🇸Denver, Colorado, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
Nova Clinical Research
🇺🇸Bradenton, Florida, United States
Infinity Clinical Research
🇺🇸Hollywood, Florida, United States
Parkinson's Disease and Movement Disorder Center
🇺🇸Boca Raton, Florida, United States
Neurological Institute, Columbia University Medical Center
🇺🇸New York, New York, United States
Henry Ford West Bloomfield Hospital
🇺🇸West Bloomfield, Michigan, United States
Quest Research Institute
🇺🇸Farmington Hills, Michigan, United States
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Rocky Mountain Movement Disorder Center
🇺🇸Englewood, Colorado, United States
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States
Charter Research
🇺🇸Winter Park, Florida, United States
University of Maryland, Neurology Ambulatory Center, Maryland Parkinson's Disease and Movement Disorder Center
🇺🇸Baltimore, Maryland, United States
Neurology Specialists of Monmouth County
🇺🇸West Long Branch, New Jersey, United States
Boston University Medical Center
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital Clinical Trials Pharmacy
🇺🇸Boston, Massachusetts, United States
Booth Gardner Parkinson's Care Center
🇺🇸Kirkland, Washington, United States
Raleigh Neurology
🇺🇸Raleigh, North Carolina, United States
The Movement Disorder Clinic of Oklahoma
🇺🇸Tulsa, Oklahoma, United States
NYU Langone Medical Center, The Marlene and Paolo Fresco Institute for Parkinson's and Movement Disorders
🇺🇸New York, New York, United States
University of Minnesota Delaware Clinical Research Unit
🇺🇸Minneapolis, Minnesota, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Movement Disorders Center
🇺🇸Scottsdale, Arizona, United States
University of California, Irvine
🇺🇸Irvine, California, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Keck School of Medicine of USC/University of Southern California
🇺🇸Los Angeles, California, United States
SC3 Research
🇺🇸Pasadena, California, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
NeuroStudies
🇺🇸Decatur, Georgia, United States
SIU Medicine
🇺🇸Springfield, Illinois, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Mayo Clinic Arizona, Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Banner Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
Struthers Parkinson's Center
🇺🇸Golden Valley, Minnesota, United States
University of Toledo, Gardner-McMaster Parkinson Center
🇺🇸Toledo, Ohio, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of Michigan Hospital
🇺🇸Ann Arbor, Michigan, United States
University of California Davis Health
🇺🇸Sacramento, California, United States
Institute for Neurodegenerative Disorders
🇺🇸New Haven, Connecticut, United States
Wake Forest Baptist Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
UNC CTRC
🇺🇸Chapel Hill, North Carolina, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States