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

Sponsor

Neuraly, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04154072

Collaborator

(none)

255

Enrollment

Locations

Arms

36.1

Anticipated Duration (Months)

4.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

For more information, please visit:

PrismPDstudy.com

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: NLY01 Drug: Vehicle	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

255 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 27, 2020

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	St. Joseph's Hospital and Medical Center - Barrow Neurological Institute	Phoenix	Arizona	United States	85013
3	Movement Disorders Center	Scottsdale	Arizona	United States	85258
4	Mayo Clinic Arizona, Mayo Clinic Scottsdale	Scottsdale	Arizona	United States	85259
5	Banner Sun Health Research Institute	Sun City	Arizona	United States	85351
6	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
7	University of California, Irvine	Irvine	California	United States	92697
8	Keck School of Medicine of USC/University of Southern California	Los Angeles	California	United States	90033
9	University of California, Los Angeles, Center for Neurotherapeutics	Los Angeles	California	United States	90095
10	SC3 Research	Pasadena	California	United States	91105
11	University of California Davis Health	Sacramento	California	United States	95816
12	University of California, San Francisco	San Francisco	California	United States	94143
13	University of Colorado	Denver	Colorado	United States	80204
14	Rocky Mountain Movement Disorder Center	Englewood	Colorado	United States	80113
15	Institute for Neurodegenerative Disorders	New Haven	Connecticut	United States	06510
16	Georgetown University Hospital	Washington	District of Columbia	United States	20007
17	Parkinson's Disease and Movement Disorder Center	Boca Raton	Florida	United States	33486
18	Nova Clinical Research	Bradenton	Florida	United States	34209
19	University of Florida	Gainesville	Florida	United States	32608
20	Infinity Clinical Research	Hollywood	Florida	United States	33024
21	Mayo Clinic Florida	Jacksonville	Florida	United States	32224
22	Visionary Investigators Network	Miami	Florida	United States	33133
23	University of Miami	Miami	Florida	United States	33136
24	Renstar Medical Research	Ocala	Florida	United States	34470
25	University of South Florida	Tampa	Florida	United States	33613
26	Charter Research	Winter Park	Florida	United States	32159
27	Augusta University	Augusta	Georgia	United States	30912
28	NeuroStudies	Decatur	Georgia	United States	30033
29	Northwestern Medical Group Neurology Clinic	Chicago	Illinois	United States	60611
30	Rush University Medical Center	Chicago	Illinois	United States	60612
31	SIU Medicine	Springfield	Illinois	United States	62702
32	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
33	University of Maryland, Neurology Ambulatory Center, Maryland Parkinson's Disease and Movement Disorder Center	Baltimore	Maryland	United States	21201
34	Johns Hopkins University School of Medicine	Baltimore	Maryland	United States	21287
35	Massachusetts General Hospital Clinical Trials Pharmacy	Boston	Massachusetts	United States	02114
36	Boston University Medical Center	Boston	Massachusetts	United States	02118
37	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
38	University of Michigan Hospital	Ann Arbor	Michigan	United States	48109
39	Quest Research Institute	Farmington Hills	Michigan	United States	48334
40	Henry Ford West Bloomfield Hospital	West Bloomfield	Michigan	United States	48322
41	Struthers Parkinson's Center	Golden Valley	Minnesota	United States	55427
42	University of Minnesota Delaware Clinical Research Unit	Minneapolis	Minnesota	United States	55414
43	Neurology Specialists of Monmouth County	West Long Branch	New Jersey	United States	07764
44	NYU Langone Medical Center, The Marlene and Paolo Fresco Institute for Parkinson's and Movement Disorders	New York	New York	United States	10017
45	Neurological Institute, Columbia University Medical Center	New York	New York	United States	10032
46	UNC CTRC	Chapel Hill	North Carolina	United States	27599
47	Duke University Medical Center	Durham	North Carolina	United States	27705
48	Raleigh Neurology	Raleigh	North Carolina	United States	27607
49	Wake Forest Baptist Health Sciences	Winston-Salem	North Carolina	United States	27157
50	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
51	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210
52	University of Toledo, Gardner-McMaster Parkinson Center	Toledo	Ohio	United States	43614
53	The Movement Disorder Clinic of Oklahoma	Tulsa	Oklahoma	United States	74136
54	Oregon Health and Science University	Portland	Oregon	United States	97239
55	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19107
56	Rhode Island Hospital	Providence	Rhode Island	United States	02903
57	Baylor College of Medicine	Houston	Texas	United States	77030
58	University of Virginia	Charlottesville	Virginia	United States	22908
59	Booth Gardner Parkinson's Care Center	Kirkland	Washington	United States	98034
60	Froedtert Hospital	Milwaukee	Wisconsin	United States	53226
61	Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8

Sponsors and Collaborators

Neuraly, Inc.

Investigators

Study Director: Dan Lee, Neuraly, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Neuraly, Inc.

ClinicalTrials.gov Identifier:

NCT04154072

Other Study ID Numbers:

NLY01-PD-1

First Posted:

Nov 6, 2019

Last Update Posted:

May 5, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of May 5, 2022