Parkinson DiseasePhase 2NCT04154072
A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease
A Phase 2 study testing NLY01 in people with Parkinson Disease, run by Neuraly, Inc. at 61 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- NLY01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 61 sitesin 2 countries
- Study dates
- 27 Feb 2020to 14 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
61 sites in 2 countries.
61 sites in 2 countries
United States60 sites
University of Michigan Hospital
Ann Arbor, Michigan, 48109
Augusta University
Augusta, Georgia, 30912
University of Maryland, Neurology Ambulatory Center, Maryland Parkinson's Disease and Movement Disorder Center
Baltimore, Maryland, 21201
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Parkinson's Disease and Movement Disorder Center
Boca Raton, Florida, 33486
Massachusetts General Hospital Clinical Trials Pharmacy
Boston, Massachusetts, 02114
Boston University Medical Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Nova Clinical Research
Bradenton, Florida, 34209
UNC CTRC
Chapel Hill, North Carolina, 27599
University of Virginia
Charlottesville, Virginia, 22908
Northwestern Medical Group Neurology Clinic
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
NeuroStudies
Decatur, Georgia, 30033
University of Colorado
Denver, Colorado, 80204
Duke University Medical Center
Durham, North Carolina, 27705
Rocky Mountain Movement Disorder Center
Englewood, Colorado, 80113
Quest Research Institute
Farmington Hills, Michigan, 48334
University of Florida
Gainesville, Florida, 32608
Struthers Parkinson's Center
Golden Valley, Minnesota, 55427
Infinity Clinical Research
Hollywood, Florida, 33024
Baylor College of Medicine
Houston, Texas, 77030
University of California, Irvine
Irvine, California, 92697
Mayo Clinic Florida
Jacksonville, Florida, 32224
University of Kansas Medical Center
Kansas City, Kansas, 66160
Booth Gardner Parkinson's Care Center
Kirkland, Washington, 98034
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Keck School of Medicine of USC/University of Southern California
Los Angeles, California, 90033
University of California, Los Angeles, Center for Neurotherapeutics
Los Angeles, California, 90095
Visionary Investigators Network
Miami, Florida, 33133
University of Miami
Miami, Florida, 33136
Froedtert Hospital
Milwaukee, Wisconsin, 53226
University of Minnesota Delaware Clinical Research Unit
Minneapolis, Minnesota, 55414
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
NYU Langone Medical Center, The Marlene and Paolo Fresco Institute for Parkinson's and Movement Disorders
New York, New York, 10017
Neurological Institute, Columbia University Medical Center
New York, New York, 10032
Renstar Medical Research
Ocala, Florida, 34470
SC3 Research
Pasadena, California, 91105
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
St. Joseph's Hospital and Medical Center - Barrow Neurological Institute
Phoenix, Arizona, 85013
Oregon Health and Science University
Portland, Oregon, 97239
Rhode Island Hospital
Providence, Rhode Island, 02903
Raleigh Neurology
Raleigh, North Carolina, 27607
University of California Davis Health
Sacramento, California, 95816
University of California, San Francisco
San Francisco, California, 94143
Movement Disorders Center
Scottsdale, Arizona, 85258
Mayo Clinic Arizona, Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
SIU Medicine
Springfield, Illinois, 62702
Banner Sun Health Research Institute
Sun City, Arizona, 85351
University of South Florida
Tampa, Florida, 33613
University of Toledo, Gardner-McMaster Parkinson Center
Toledo, Ohio, 43614
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, 74136
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
Neurology Specialists of Monmouth County
West Long Branch, New Jersey, 07764
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, 27157
Charter Research
Winter Park, Florida, 32159
About this study
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
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.
- Conditions
- Parkinson Disease
- Being tested
- NLY01, Vehicle
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NLY01Drug
exenatide and polyethylene glycol (PEG)
VehicleDrug
Saline (Sodium Chloride)
| Study group | Role | What they receive |
|---|---|---|
| NLY01 (2.5 mg) | Active comparator | NLY01 2.5 mg injection Receives: Drug: NLY01 |
| NLY01 (5.0 mg) | Active comparator | NLY01 5.0 mg injection Receives: Drug: NLY01 |
| Vehicle | Placebo comparator | inactive drug, injection Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start27 Feb 2020
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuraly, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Lee, Study director, Neuraly, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154072
- Sponsor's protocol ID
- NLY01-PD-1
- Status last verified
- Mar 2024
- First submitted
- 4 Nov 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McGarry A, Rosanbalm S, Leinonen M, Olanow CW, To D, Bell A, Lee D, Chang J, Dubow J, Dhall R, Burdick D, Parashos S, Feuerstein J, Quinn J, Pahwa R, Afshari M, Ramirez-Zamora A, Chou K, Tarakad A, Luca C, Klos K, Bordelon Y, St Hiliare MH, Shprecher D, Lee S, Dawson TM, Roschke V, Kieburtz K. Safety, tolerability, and efficacy of NLY01 in early untreated Parkinson's disease: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2024 Jan;23(1):37-45. doi: 10.1016/S1474-4422(23)00378-2.
PubMed 38101901
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04154072
- Acronym / sponsor ID
- NLY01-PD-1
- Conditions
- Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Neuraly, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NLY01 (2.5 mg) | Active comparator | Drug: NLY01NLY01 2.5 mg injection |
| NLY01 (5.0 mg) | Active comparator | Drug: NLY01NLY01 5.0 mg injection |
| Vehicle | Placebo comparator | Drug: Vehicleinactive drug, injection |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NLY01exenatide and polyethylene glycol (PEG) | Drug | NLY01 (2.5 mg), NLY01 (5.0 mg) |
| VehicleSaline (Sodium Chloride) | Drug | Vehicle |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 38101901McGarry A, Rosanbalm S, Leinonen M, Olanow CW, To D, Bell A, Lee D, Chang J, Dubow J, Dhall R, Burdick D, Parashos S, Feuerstein J, Quinn J, Pahwa R, Afshari M, Ramirez-Zamora A, Chou K, Tarakad A, Luca C, Klos K, Bordelon Y, St Hiliare MH, Shprecher D, Lee S, Dawson TM, Roschke V, Kieburtz K. Safety, tolerability, and efficacy of NLY01 in early untreated Parkinson's disease: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2024 Jan;23(1):37-45. doi: 10.1016/S1474-4422(23)00378-2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Lee study director
Neuraly, Inc.
61 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NLY01 in people with Parkinson Disease, run by Neuraly, Inc. at 61 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04154072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.