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

Neuraly, Inc.255 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

255

Conditions

Parkinson Disease

Interventions

NLY01DRUG

exenatide and polyethylene glycol (PEG)

VehicleDRUG

Saline (Sodium Chloride)

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (61)

Outcomes

Primary Outcomes

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.

Time frame: 36 weeks

Data from ClinicalTrials.gov

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University of Alabama at Birmingham

Birmingham, Alabama, United States

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

...and 51 more locations