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

Condition

Eligibility

Eligible Ages
Between 30 Years and 80 Years
Eligible Genders
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

ArmDescriptionAssigned Intervention
Active Comparator
NLY01 (2.5 mg)
NLY01 2.5 mg injection
  • Drug: NLY01
    exenatide and polyethylene glycol (PEG)
Active Comparator
NLY01 (5.0 mg)
NLY01 5.0 mg injection
  • Drug: NLY01
    exenatide and polyethylene glycol (PEG)
Placebo Comparator
Vehicle
inactive drug, injection
  • Drug: Vehicle
    Saline (Sodium Chloride)

Recruiting Locations

Boston University Medical Center
Boston, Massachusetts 02118

More Details

Status
Recruiting
Sponsor
Neuraly, Inc.

Study Contact

Chris Trizna
888-497-4890
ParkinsonsStudy@cssienroll.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.