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
Sponsor:
Brief Summary:
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
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
- University of California, Irvine, Irvine, California, United States, 92697
- Keck School of Medicine of USC/University of Southern California, Los Angeles, California, United States, 90033
- SC3 Research, Pasadena, California, United States, 91105
- University of California, San Francisco, San Francisco, California, United States, 94143
