A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease
- Registration Number
- NCT04154072
- Lead Sponsor
- Neuraly, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 255
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NLY01 (2.5 mg) NLY01 NLY01 2.5 mg injection Vehicle Vehicle inactive drug, injection NLY01 (5.0 mg) NLY01 NLY01 5.0 mg injection
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (61)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
St. Joseph's Hospital and Medical Center - Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Movement Disorders Center
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic Arizona, Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Banner Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
University of California, Irvine
🇺🇸Irvine, California, United States
Keck School of Medicine of USC/University of Southern California
🇺🇸Los Angeles, California, United States
University of California, Los Angeles, Center for Neurotherapeutics
🇺🇸Los Angeles, California, United States
SC3 Research
🇺🇸Pasadena, California, United States
Scroll for more (51 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States