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. For more information, please visit: www.PrismPDstudy.com

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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Neuraly, Inc.
ID
NCT04154072
Phase
Phase 2
Study Type
Interventional
Last Updated