Parkinson Disease
Conditions
Brief 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.
Interventions
DRUGNLY01
exenatide and polyethylene glycol (PEG)
DRUGVehicle
Saline (Sodium Chloride)
Sponsors
Neuraly, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Unified Parkinson's Disease Rating Scale in combined score of Parts II and III from baseline to 36 weeks | 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. |
Countries
Canada, United States
Outcome results
None listed