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

Completed · Phase 2

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT04154072

Run by

Neuraly, Inc.

People needed

255

Starts

2020-02-27

Expected to finish

2023-02-14

Last updated by the study team

2024-09-19

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• University of South Florida — Tampa, Florida, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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