A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease
Purpose
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. For more information, please visit: www.PrismPDstudy.com
Condition
- Parkinson Disease
Eligibility
- Eligible Ages
- Between 30 Years and 80 Years
- Eligible Genders
- All
- Accepts 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 Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator NLY01 (2.5 mg) |
NLY01 2.5 mg injection |
|
Active Comparator NLY01 (5.0 mg) |
NLY01 5.0 mg injection |
|
Placebo Comparator Vehicle |
inactive drug, injection |
|
Recruiting Locations
University of Alabama at Birmingham
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Movement Disorders Center
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Mayo Clinic Arizona, Mayo Clinic Scottsdale
Scottsdale, Arizona 85259
Scottsdale, Arizona 85259
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
University of California, Irvine
Irvine, California 92697
Irvine, California 92697
Keck School of Medicine of USC/University of Southern California
Los Angeles, California 90033
Los Angeles, California 90033
University of California, Los Angeles, Center for Neurotherapeutics
Los Angeles, California 90095
Los Angeles, California 90095
SC3 Research
Pasadena, California 91105
Pasadena, California 91105
University of California, San Francisco
San Francisco, California 94143
San Francisco, California 94143
University of Colorado
Denver, Colorado 80204
Denver, Colorado 80204
Rocky Mountain Movement Disorder Center
Englewood, Colorado 80113
Englewood, Colorado 80113
Institute for Neurodegenerative Disorders
New Haven, Connecticut 06510
New Haven, Connecticut 06510
Parkinson's Disease and Movement Disorder Center
Boca Raton, Florida 33486
Boca Raton, Florida 33486
Nova Clinical Research
Bradenton, Florida 34209
Bradenton, Florida 34209
University of Florida
Gainesville, Florida 32608
Gainesville, Florida 32608
Infinity Clinical Research
Hollywood, Florida 33024
Hollywood, Florida 33024
Mayo Clinic Florida
Jacksonville, Florida 32224
Jacksonville, Florida 32224
University of Miami
Miami, Florida 33136
Miami, Florida 33136
Renstar Medical Research
Ocala, Florida 34470
Ocala, Florida 34470
University of South Florida
Tampa, Florida 33613
Tampa, Florida 33613
Charter Research
Winter Park, Florida 32159
Winter Park, Florida 32159
Augusta University
Augusta, Georgia 30912
Augusta, Georgia 30912
Northwestern Medical Group Neurology Clinic
Chicago, Illinois 60611
Chicago, Illinois 60611
Rush University Medical Center
Chicago, Illinois 60612
Chicago, Illinois 60612
SIU Medicine
Springfield, Illinois 62702
Springfield, Illinois 62702
University of Kansas Medical Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
University of Maryland, Neurology Ambulatory Center, Maryland Parkinson's Disease and Movement Disorder Center
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Massachusetts General Hospital Clinical Trials Pharmacy
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Boston University Medical Center
Boston, Massachusetts 02118
Boston, Massachusetts 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
University of Michigan Hospital
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Quest Research Institute
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48334
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
West Bloomfield, Michigan 48322
Struthers Parkinson's Center
Golden Valley, Minnesota 55427
Golden Valley, Minnesota 55427
Neurology Specialists of Monmouth County
West Long Branch, New Jersey 07764
West Long Branch, New Jersey 07764
Neurological Institute, Columbia University Medical Center
New York, New York 10032
New York, New York 10032
UNC CTRC
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
Duke University Medical Center
Durham, North Carolina 27705
Durham, North Carolina 27705
Raleigh Neurology
Raleigh, North Carolina 27607
Raleigh, North Carolina 27607
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
Columbus, Ohio 43210
University of Toledo, Gardner-McMaster Parkinson Center
Toledo, Ohio 43614
Toledo, Ohio 43614
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma 74136
Tulsa, Oklahoma 74136
Oregon Health and Science University
Portland, Oregon 97239
Portland, Oregon 97239
University of Pennsylvania
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Rhode Island Hospital
Providence, Rhode Island 02903
Providence, Rhode Island 02903
Baylor College of Medicine
Houston, Texas 77030
Houston, Texas 77030
University of Virginia
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
Booth Gardner Parkinson's Care Center
Kirkland, Washington 98034
Kirkland, Washington 98034
Froedtert Hospital
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
More Details
- NCT ID
- NCT04154072
- Status
- Recruiting
- Sponsor
- Neuraly, Inc.