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

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

ArmDescriptionAssigned Intervention
Active Comparator
NLY01 (2.5 mg)
NLY01 2.5 mg injection
  • Drug: NLY01
    exenatide and polyethylene glycol (PEG)
Active Comparator
NLY01 (5.0 mg)
NLY01 5.0 mg injection
  • Drug: NLY01
    exenatide and polyethylene glycol (PEG)
Placebo Comparator
Vehicle
inactive drug, injection
  • Drug: Vehicle
    Saline (Sodium Chloride)

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233

Movement Disorders Center
Scottsdale, Arizona 85258

Mayo Clinic Arizona, Mayo Clinic Scottsdale
Scottsdale, Arizona 85259

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205

University of California, Irvine
Irvine, California 92697

Keck School of Medicine of USC/University of Southern California
Los Angeles, California 90033

University of California, Los Angeles, Center for Neurotherapeutics
Los Angeles, California 90095

SC3 Research
Pasadena, California 91105

University of California, San Francisco
San Francisco, California 94143

University of Colorado
Denver, Colorado 80204

Rocky Mountain Movement Disorder Center
Englewood, Colorado 80113

Institute for Neurodegenerative Disorders
New Haven, Connecticut 06510

Parkinson's Disease and Movement Disorder Center
Boca Raton, Florida 33486

Nova Clinical Research
Bradenton, Florida 34209

University of Florida
Gainesville, Florida 32608

Infinity Clinical Research
Hollywood, Florida 33024

Mayo Clinic Florida
Jacksonville, Florida 32224

University of Miami
Miami, Florida 33136

Renstar Medical Research
Ocala, Florida 34470

University of South Florida
Tampa, Florida 33613

Charter Research
Winter Park, Florida 32159

Augusta University
Augusta, Georgia 30912

Northwestern Medical Group Neurology Clinic
Chicago, Illinois 60611

Rush University Medical Center
Chicago, Illinois 60612

SIU Medicine
Springfield, Illinois 62702

University of Kansas Medical Center
Kansas City, Kansas 66160

University of Maryland, Neurology Ambulatory Center, Maryland Parkinson's Disease and Movement Disorder Center
Baltimore, Maryland 21201

Massachusetts General Hospital Clinical Trials Pharmacy
Boston, Massachusetts 02114

Boston University Medical Center
Boston, Massachusetts 02118

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215

University of Michigan Hospital
Ann Arbor, Michigan 48109

Quest Research Institute
Farmington Hills, Michigan 48334

Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322

Neurology Specialists of Monmouth County
West Long Branch, New Jersey 07764

Neurological Institute, Columbia University Medical Center
New York, New York 10032

UNC CTRC
Chapel Hill, North Carolina 27599

Duke University Medical Center
Durham, North Carolina 27705

Raleigh Neurology
Raleigh, North Carolina 27607

Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina 27157

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

The Ohio State University Wexner Medical Center
Columbus, Ohio 43210

University of Toledo, Gardner-McMaster Parkinson Center
Toledo, Ohio 43614

The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma 74136

Oregon Health and Science University
Portland, Oregon 97239

University of Pennsylvania
Philadelphia, Pennsylvania 19107

Baylor College of Medicine
Houston, Texas 77030

University of Virginia
Charlottesville, Virginia 22908

Booth Gardner Parkinson's Care Center
Kirkland, Washington 98034

Froedtert Hospital
Milwaukee, Wisconsin 53226

More Details

NCT ID
NCT04154072
Status
Recruiting
Sponsor
Neuraly, Inc.

Study Contact

Chris Trizna
888-497-4890
ParkinsonsStudy@cssienroll.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.