This study is in progress, not accepting new patients

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

a study on Parkinson's Disease

Summary

Eligibility
for people ages 30-80 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

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.

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

Keywords

Parkinson Disease, NLY01, Vehicle, NLY01 (2.5 mg), NLY01 (5.0 mg)

Eligibility

You can join if…

Open to people ages 30-80

  • 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 CAN'T join 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

Locations

  • University of California, Irvine
    Irvine California 92697 United States
  • University of California, Los Angeles, Center for Neurotherapeutics
    Los Angeles California 90095 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Neuraly, Inc.
ID
NCT04154072
Phase
Phase 2 Parkinson's Disease Research Study
Study Type
Interventional
Participants
About 255 people participating
Last Updated