A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04154072
• Other study ID #: NLY01-PD-1
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 27, 2020
• Est. completion date: March 2023

Study information

• Verified date: November 2022
• Source: Neuraly, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 255
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• NLY01
exenatide and polyethylene glycol (PEG)
• Vehicle
Saline (Sodium Chloride)

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario
United States	University of Michigan Hospital	Ann Arbor	Michigan
United States	Augusta University	Augusta	Georgia
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	University of Maryland, Neurology Ambulatory Center, Maryland Parkinson's Disease and Movement Disorder Center	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Parkinson's Disease and Movement Disorder Center	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston University Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital Clinical Trials Pharmacy	Boston	Massachusetts
United States	Nova Clinical Research	Bradenton	Florida
United States	UNC CTRC	Chapel Hill	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern Medical Group Neurology Clinic	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	NeuroStudies	Decatur	Georgia
United States	University of Colorado	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Rocky Mountain Movement Disorder Center	Englewood	Colorado
United States	Quest Research Institute	Farmington Hills	Michigan
United States	University of Florida	Gainesville	Florida
United States	Struthers Parkinson's Center	Golden Valley	Minnesota
United States	Infinity Clinical Research	Hollywood	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	University of California, Irvine	Irvine	California
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Booth Gardner Parkinson's Care Center	Kirkland	Washington
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	University of California, Los Angeles, Center for Neurotherapeutics	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Visionary Investigators Network	Miami	Florida
United States	Froedtert Hospital	Milwaukee	Wisconsin
United States	University of Minnesota Delaware Clinical Research Unit	Minneapolis	Minnesota
United States	Institute for Neurodegenerative Disorders	New Haven	Connecticut
United States	Neurological Institute, Columbia University Medical Center	New York	New York
United States	NYU Langone Medical Center, The Marlene and Paolo Fresco Institute for Parkinson's and Movement Disorders	New York	New York
United States	Renstar Medical Research	Ocala	Florida
United States	SC3 Research	Pasadena	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital and Medical Center - Barrow Neurological Institute	Phoenix	Arizona
United States	Oregon Health and Science University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Raleigh Neurology	Raleigh	North Carolina
United States	University of California Davis Health	Sacramento	California
United States	University of California, San Francisco	San Francisco	California
United States	Mayo Clinic Arizona, Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	Movement Disorders Center	Scottsdale	Arizona
United States	SIU Medicine	Springfield	Illinois
United States	Banner Sun Health Research Institute	Sun City	Arizona
United States	University of South Florida	Tampa	Florida
United States	University of Toledo, Gardner-McMaster Parkinson Center	Toledo	Ohio
United States	The Movement Disorder Clinic of Oklahoma	Tulsa	Oklahoma
United States	Georgetown University Hospital	Washington	District of Columbia
United States	Henry Ford West Bloomfield Hospital	West Bloomfield	Michigan
United States	Neurology Specialists of Monmouth County	West Long Branch	New Jersey
United States	Wake Forest Baptist Health Sciences	Winston-Salem	North Carolina
United States	Charter Research	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Neuraly, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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