A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease
Purpose
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.
Condition
- Parkinson Disease
Eligibility
- Eligible Ages
- Between 30 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator NLY01 (2.5 mg) |
NLY01 2.5 mg injection |
|
|
Active Comparator NLY01 (5.0 mg) |
NLY01 5.0 mg injection |
|
|
Placebo Comparator Vehicle |
inactive drug, injection |
|
Recruiting Locations
More Details
- NCT ID
- NCT04154072
- Status
- Completed
- Sponsor
- Neuraly, Inc.