A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease

• ClinicalTrials.gov Identifier: NCT04154072
• Recruitment Status: Active, not recruiting
• First Posted: November 6, 2019
• Last Update Posted: November 17, 2022
• Sponsor: Neuraly, Inc.
• Information provided by (Responsible Party): Neuraly, Inc.

Tracking Information

• First Submitted Date: November 4, 2019
• First Posted Date: November 6, 2019
• Last Update Posted Date: November 17, 2022
• Actual Study Start Date: February 27, 2020
• Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 5, 2019)

Change in Unified Parkinson's Disease Rating Scale in combined score of Parts II and III from baseline to 36 weeks [ Time Frame: 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.

Original Primary Outcome Measures (submitted: November 4, 2019)

Change in Unified Parkinson's Disease Rating Scale in combined score of Parts II and III from baseline to 36 weeks [ Time Frame: 36 weeks ]

This is the Unified Parkinson's disease rating scale assessment (MDS-UPDRS). The investigator will assess II and III components of the MDS-UPDRS. MDS-UPDRS Part II assesses motor aspects of experiences of daily living. MDS-UPDRS Part III assesses motor signs of Parkinson's Disease.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease
• Official Title: 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Parkinson Disease

Intervention

• Drug: NLY01
  exenatide and polyethylene glycol (PEG)
• Drug: Vehicle
  Saline (Sodium Chloride)

Study Arms

• Active Comparator: NLY01 (2.5 mg)
  NLY01 2.5 mg injection
  Intervention: Drug: NLY01
• Active Comparator: NLY01 (5.0 mg)
  NLY01 5.0 mg injection
  Intervention: Drug: NLY01
• Placebo Comparator: Vehicle
  inactive drug, injection
  Intervention: Drug: Vehicle

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 4, 2022): 255
• Original Estimated Enrollment (submitted: November 4, 2019): 240
• Estimated Study Completion Date: March 2023
• Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT04154072
• Other Study ID Numbers: NLY01-PD-1
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Neuraly, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Neuraly, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Dan Lee; Neuraly, Inc.

• PRS Account: Neuraly, Inc.
• Verification Date: November 2022