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

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ClinicalTrials.gov Identifier: NCT04154072
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Neuraly, Inc.

Tracking Information
First Submitted Date  ICMJE November 4, 2019
First Posted Date  ICMJE November 6, 2019
Last Update Posted Date October 5, 2021
Actual Study Start Date  ICMJE February 27, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease
Official Title  ICMJE 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.

For more information, please visit:

PrismPDstudy.com

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: NLY01
    exenatide and polyethylene glycol (PEG)
  • Drug: Vehicle
    Saline (Sodium Chloride)
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2019)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chris Trizna 888-497-4890 ParkinsonsStudy@cssienroll.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04154072
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Undecided
Responsible Party Neuraly, Inc.
Study Sponsor  ICMJE Neuraly, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dan Lee Neuraly, Inc.
PRS Account Neuraly, Inc.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP