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

Primary Purpose

Parkinson Disease

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NLY01
Vehicle
Sponsored by
Neuraly, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • St. Joseph's Hospital and Medical Center - Barrow Neurological Institute
  • Movement Disorders Center
  • Mayo Clinic Arizona, Mayo Clinic Scottsdale
  • Banner Sun Health Research Institute
  • University of Arkansas for Medical Sciences
  • University of California, Irvine
  • Keck School of Medicine of USC/University of Southern California
  • University of California, Los Angeles, Center for Neurotherapeutics
  • SC3 Research
  • University of California Davis Health
  • University of California, San Francisco
  • University of Colorado
  • Rocky Mountain Movement Disorder Center
  • Institute for Neurodegenerative Disorders
  • Georgetown University Hospital
  • Parkinson's Disease and Movement Disorder Center
  • Nova Clinical Research
  • University of Florida
  • Infinity Clinical Research
  • Mayo Clinic Florida
  • Visionary Investigators Network
  • University of Miami
  • Renstar Medical Research
  • University of South Florida
  • Charter Research
  • Augusta University
  • NeuroStudies
  • Northwestern Medical Group Neurology Clinic
  • Rush University Medical Center
  • SIU Medicine
  • University of Kansas Medical Center
  • University of Maryland, Neurology Ambulatory Center, Maryland Parkinson's Disease and Movement Disorder Center
  • Johns Hopkins University School of Medicine
  • Massachusetts General Hospital Clinical Trials Pharmacy
  • Boston University Medical Center
  • Beth Israel Deaconess Medical Center
  • University of Michigan Hospital
  • Quest Research Institute
  • Henry Ford West Bloomfield Hospital
  • Struthers Parkinson's Center
  • University of Minnesota Delaware Clinical Research Unit
  • Neurology Specialists of Monmouth County
  • NYU Langone Medical Center, The Marlene and Paolo Fresco Institute for Parkinson's and Movement Disorders
  • Neurological Institute, Columbia University Medical Center
  • UNC CTRC
  • Duke University Medical Center
  • Raleigh Neurology
  • Wake Forest Baptist Health Sciences
  • University Hospitals Cleveland Medical Center
  • The Ohio State University Wexner Medical Center
  • University of Toledo, Gardner-McMaster Parkinson Center
  • The Movement Disorder Clinic of Oklahoma
  • Oregon Health and Science University
  • University of Pennsylvania
  • Rhode Island Hospital
  • Baylor College of Medicine
  • University of Virginia
  • Booth Gardner Parkinson's Care Center
  • Froedtert Hospital
  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

NLY01 (2.5 mg)

NLY01 (5.0 mg)

Vehicle

Arm Description

NLY01 2.5 mg injection

NLY01 5.0 mg injection

inactive drug, injection

Outcomes

Primary Outcome Measures

Change in Unified Parkinson's Disease Rating Scale in combined score of Parts II and III from baseline to 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

Full Information

First Posted
November 4, 2019
Last Updated
November 14, 2022
Sponsor
Neuraly, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04154072
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 27, 2020 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuraly, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NLY01 (2.5 mg)
Arm Type
Active Comparator
Arm Description
NLY01 2.5 mg injection
Arm Title
NLY01 (5.0 mg)
Arm Type
Active Comparator
Arm Description
NLY01 5.0 mg injection
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
inactive drug, injection
Intervention Type
Drug
Intervention Name(s)
NLY01
Intervention Description
exenatide and polyethylene glycol (PEG)
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Saline (Sodium Chloride)
Primary Outcome Measure Information:
Title
Change in Unified Parkinson's Disease Rating Scale in combined score of Parts II and III from baseline to 36 weeks
Description
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.
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Lee
Organizational Affiliation
Neuraly, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center - Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Movement Disorders Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Mayo Clinic Arizona, Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Banner Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Keck School of Medicine of USC/University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, Los Angeles, Center for Neurotherapeutics
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
SC3 Research
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
University of California Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Rocky Mountain Movement Disorder Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Institute for Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Parkinson's Disease and Movement Disorder Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Nova Clinical Research
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Infinity Clinical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Visionary Investigators Network
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Charter Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
NeuroStudies
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Northwestern Medical Group Neurology Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
SIU Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Maryland, Neurology Ambulatory Center, Maryland Parkinson's Disease and Movement Disorder Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital Clinical Trials Pharmacy
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Quest Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Henry Ford West Bloomfield Hospital
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Struthers Parkinson's Center
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55427
Country
United States
Facility Name
University of Minnesota Delaware Clinical Research Unit
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
Neurology Specialists of Monmouth County
City
West Long Branch
State/Province
New Jersey
ZIP/Postal Code
07764
Country
United States
Facility Name
NYU Langone Medical Center, The Marlene and Paolo Fresco Institute for Parkinson's and Movement Disorders
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Neurological Institute, Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
UNC CTRC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Raleigh Neurology
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wake Forest Baptist Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Toledo, Gardner-McMaster Parkinson Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
The Movement Disorder Clinic of Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Booth Gardner Parkinson's Care Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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