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| Name | Class |
|---|---|
| Qiagen Manchester Limited | UNKNOWN |
| Roche Diagnostic Ltd. | INDUSTRY |
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The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 40-80 years with early Parkinson's Disease (PD) who have predicted elevations in the activity of the "leucine-rich repeat kinase 2" ("LRRK2" for short) pathway based on their genetic profile. A DNA test will be used to identify the "LRRK2-driven" population with predicted elevation in the LRRK2 pathway.
NEU-411-PD201 is a Phase 2, randomized, placebo-controlled, proof-of-concept study and open-label extension (OLE) in participants with early Parkinson's Disease (PD) who have LRRK2-driven PD as measured by an investigational companion diagnostic genetic test (CDx). The study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NEU-411, an orally-administered, potent, selective, bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity as compared to placebo.
After participants are screened for inclusion in the randomized, placebo-controlled portion of the study, approximately 150 participants will be randomized in a 1:1 allocation to NEU-411 30 mg once per day or placebo for a 52-week treatment period with a safety follow-up visit within 2 weeks after the last treatment visit. Eligible participants may enroll in the OLE and receive treatment for an additional 26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEU-411 | Experimental | Orally-administered NEU-411 |
|
| Placebo | Placebo Comparator | Orally-administered matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEU-411 | Drug | NEU-411, a potent, selective, orally bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo | From enrollment to the end of treatment at 52 weeks | |
| Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo | From enrollment to the end of study at 54 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Change from baseline to Week 52 in motor function/nonmotor as measured by Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Additional inclusion and exclusion criteria for the RCP and OLE are outlined in the full study protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatta B Nahab, MD, FAAN, FANA | Contact | 650-228-2527 | clinicaltrials@neuron23.com |
| Name | Affiliation | Role |
|---|---|---|
| Fatta B Nahab, MD, FAAN FANA | Neuron23 Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Sun Health Research Institute | Recruiting | Sun City | Arizona | 85351 | United States |
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The Sponsor is also masked.
| Placebo | Other | Orally-administered matched placebo |
|
| University of Arkansas | Recruiting | Little Rock | Arkansas | 72205 | United States |
|
| Neuro-Pain Medical Center | Recruiting | Fresno | California | 93710 | United States |
|
| University of California, Irvine | Recruiting | Irvine | California | 92697 | United States |
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| University of California, Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
|
| Esperanza Clinical | Recruiting | Murrieta | California | 92562 | United States |
|
| Parkinson's Research Centers of America - Palo Alto | Recruiting | Palo Alto | California | 94301 | United States |
|
| Sutter Neuroscience Institute | Recruiting | Sacramento | California | 95816 | United States |
|
| University of Colorado - Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
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| Parkinson's Disease and Movement Disorders Center of Boca Raton | Recruiting | Boca Raton | Florida | 33486 | United States |
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| University of Florida | Recruiting | Gainesville | Florida | 32608 | United States |
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| Neurology One | Recruiting | Orlando | Florida | 32825 | United States |
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| USF Parkinson's & Movement Disorders Clinic | Recruiting | Tampa | Florida | 33613 | United States |
|
| Emory University | Recruiting | Atlanta | Georgia | 30329 | United States |
|
| Augusta University | Recruiting | Augusta | Georgia | 30912 | United States |
|
| Northwestern Medical Group, Department of Neurology | Recruiting | Chicago | Illinois | 60611 | United States |
|
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
|
| University of Kentucky | Recruiting | Lexington | Kentucky | 40536 | United States |
|
| Ochsner Clinic Foundation | Recruiting | New Orleans | Louisiana | 70121 | United States |
|
| University of Maryland | Recruiting | Baltimore | Maryland | 21201 | United States |
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| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Quest Research Institute | Recruiting | Farmington Hills | Michigan | 48334 | United States |
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| Struthers Parkinson Center | Recruiting | Golden Valley | Minnesota | 55427 | United States |
|
| Cleveland Clinic | Recruiting | Las Vegas | Nevada | 89106 | United States |
|
| University of New Mexico | Recruiting | Albuquerque | New Mexico | 87106 | United States |
|
| Northwell Health | Recruiting | Manhasset | New York | 11030 | United States |
|
| Icahn School of Medicine at Mount Sinai/Mount Sinai West | Recruiting | New York | New York | 10019 | United States |
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| Columbia University | Recruiting | New York | New York | 10032 | United States |
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| University of Rochester | Recruiting | Rochester | New York | 14618 | United States |
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| University of North Carolina - Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
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| The Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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| The Movement Disorder Clinic of Oklahoma | Recruiting | Tulsa | Oklahoma | 74136 | United States |
|
| Oregon Health & Science University (OHSU) | Recruiting | Portland | Oregon | 97239 | United States |
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| Thomas Jefferson University Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| Vanderbilt University | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Neurology Consultants of Dallas PA | Recruiting | Dallas | Texas | 75243 | United States |
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| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
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| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| Central Texas Neurology Consultants | Recruiting | Round Rock | Texas | 78681 | United States |
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| University of Utah Movement Division | Recruiting | Salt Lake City | Utah | 84108 | United States |
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| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
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| EvergreenHealth | Recruiting | Kirkland | Washington | 98034 | United States |
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| Inland Northwest Research | Recruiting | Spokane | Washington | 99202 | United States |
|
| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| Rambam Medical Center | Not yet recruiting | Haifa | 3109601 | Israel |
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| Shaare Zedek Medical Center | Recruiting | Jerusalem | 9103102 | Israel |
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| Sheba Medical Center | Not yet recruiting | Ramat Gan | 5262000 | Israel |
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| Tel Aviv Medical Center | Not yet recruiting | Tel Aviv | 6423906 | Israel |
|
| IRCCS Ospedale San Raffaele (HSR) - Dipartimento Di Neurologia | Recruiting | Milan | 20132 | Italy |
|
| Universita Degli Studi Della Campania "Luigi Vanvitelli" - Azienda Ospedaliera Universitaria | Recruiting | Naples | 80138 | Italy |
|
| Universita Degli Studi Di Padova - Azienda Ospedaliera Di Padova - Clinica Neurologica | Recruiting | Padua | 35128 | Italy |
|
| Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero Di Santa Chiara | Recruiting | Pisa | 56126 | Italy |
|
| Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana | Recruiting | Rome | 00166 | Italy |
|
| Fondazione Policilinico Universitario A Gemelli IRCCS | Recruiting | Rome | 00168 | Italy |
|
| Centrum Medyczne Neuromed | Recruiting | Bydgoszcz | 85-163 | Poland |
|
| NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis Lech Szczechowski | Recruiting | Katowice | 32-600 | Poland |
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| Pro Life Medica Sp. z o. o. ETA Lublin | Recruiting | Lublin | 20-412 | Poland |
|
| Insula Badania Sp. Z o.o. | Recruiting | Warsaw | 02-699 | Poland |
|
| Policlinica Gipuzkoa - Centro de Investigacion Parkinson (CIP) | Recruiting | San Sebastián | Donostia | 20014 | Spain |
|
| Instituto de Investigacion Sanitaria Biocruces Bizkaia - Hospital Universitario Cruces | Not yet recruiting | Barakaldo | 49003 | Spain |
|
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
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| Hospital Clinic de Barcelona (Hospital Clinic i Provincial) - Barnaclinic S.A. | Recruiting | Barcelona | 08036 | Spain |
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| Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa | Recruiting | Madrid | 28006 | Spain |
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| Hospital Universitario HM Puerta del Sur | Recruiting | Móstoles | 28938 | Spain |
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| Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS) | Recruiting | Seville | 41013 | Spain |
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| St George's Hospital, University of London | Recruiting | London | England | SW17 0QT | United Kingdom |
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| University College London Hospitals NHS Foundation Trust | Recruiting | London | England | WC1N 3BG | United Kingdom |
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| Clinical Aging Research Unit, Newcastle University | Recruiting | Newcastle upon Tyne | England | NE4 5PL | United Kingdom |
|
| Ninewells Hospital and Medical School - NHS Tayside | Recruiting | Dundee | Scotland | DD19SY | United Kingdom |
|
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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