A Phase 2 Study of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease

PHASE2RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

January 17, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2027

Conditions
Parkinson DiseaseParkinsonIdiopathic Parkinson DiseaseEarly Parkinson Disease (Early PD)Parkinson Disease, Idiopathic
Interventions
DRUG

NEU-411

NEU-411, a potent, selective, orally bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity

OTHER

Placebo

Orally-administered matched placebo

Trial Locations (65)

10019

RECRUITING

Icahn School of Medicine at Mount Sinai/Mount Sinai West, New York

10032

RECRUITING

Columbia University, New York

11021

RECRUITING

Northwell Health, Great Neck

14618

RECRUITING

University of Rochester, Rochester

19107

NOT_YET_RECRUITING

Thomas Jefferson University Hospital, Philadelphia

20014

NOT_YET_RECRUITING

Policlinica Gipuzkoa - Centro de Investigacion Parkinson (CIP), San Sebastián

20132

NOT_YET_RECRUITING

IRCCS Ospedale San Raffaele (HSR) - Dipartimento Di Neurologia, Milan

21201

NOT_YET_RECRUITING

University of Maryland, Baltimore

22903

RECRUITING

University of Virginia, Charlottesville

27599

RECRUITING

University of North Carolina - Chapel Hill, Chapel Hill

27607

NOT_YET_RECRUITING

Velocity Clinical Research at Raleigh Neurology, Raleigh

28006

NOT_YET_RECRUITING

Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa, Madrid

28938

NOT_YET_RECRUITING

Hospital Universitario HM Puerta del Sur, Móstoles

29425

RECRUITING

Medical University of South Carolina, Charleston

30329

RECRUITING

Emory University, Atlanta

30912

RECRUITING

Augusta University, Augusta

32608

RECRUITING

University of Florida, Gainesville

32825

RECRUITING

Neurology One, Orlando

33486

RECRUITING

Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton

33613

RECRUITING

USF Parkinson's & Movement Disorders Clinic, Tampa

35128

NOT_YET_RECRUITING

Universita Degli Studi Di Padova - Azienda Ospedaliera Di Padova - Clinica Neurologica, Padua

37232

RECRUITING

Vanderbilt University, Nashville

40536

RECRUITING

University of Kentucky, Lexington

41013

NOT_YET_RECRUITING

Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS), Seville

43210

RECRUITING

The Ohio State University, Columbus

48334

RECRUITING

Quest Research Institute, Farmington Hills

49003

NOT_YET_RECRUITING

Instituto de Investigacion Sanitaria Biocruces Bizkaia - Hospital Universitario Cruces, Barakaldo

53226

NOT_YET_RECRUITING

Medical College of Wisconsin, Milwaukee

55427

RECRUITING

Struthers Parkinson Center, Golden Valley

56126

NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero Di Santa Chiara, Pisa

60611

RECRUITING

Northwestern Medical Group, Department of Neurology, Chicago

66160

RECRUITING

University of Kansas Medical Center, Kansas City

70121

NOT_YET_RECRUITING

Ochsner Clinic Foundation, New Orleans

72205

RECRUITING

University of Arkansas, Little Rock

74136

RECRUITING

The Movement Disorder Clinic of Oklahoma, Tulsa

75243

NOT_YET_RECRUITING

Neurology Consultants of Dallas PA, Dallas

77030

RECRUITING

Baylor College of Medicine, Houston

NOT_YET_RECRUITING

The University of Texas Health Science Center at Houston, Houston

78681

RECRUITING

Central Texas Neurology Consultants, Round Rock

80045

RECRUITING

University of Colorado - Anschutz Medical Campus, Aurora

80138

NOT_YET_RECRUITING

"Universita Degli Studi Della Campania Luigi Vanvitelli - Azienda Ospedaliera Universitaria", Napoli

84108

RECRUITING

University of Utah Movement Division, Salt Lake City

85351

RECRUITING

Banner Sun Health Research Institute, Sun City

89106

RECRUITING

Cleveland Clinic, Las Vegas

90095

RECRUITING

University of California, Los Angeles, Los Angeles

92562

NOT_YET_RECRUITING

Esperanza Clinical, Murrieta

92697

RECRUITING

University of California, Irvine, Irvine

93710

RECRUITING

Neuro-Pain Medical Center, Fresno

94301

NOT_YET_RECRUITING

Parkinson's Research Centers of America - Palo Alto, Palo Alto

97239

RECRUITING

Oregon Health & Science University (OHSU), Portland

98034

RECRUITING

EvergreenHealth, Kirkland

06510

NOT_YET_RECRUITING

Invicro, New Haven

02215

RECRUITING

Beth Israel Deaconess Medical Center, Boston

00166

NOT_YET_RECRUITING

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana, Rome

00168

NOT_YET_RECRUITING

Fondazione Policilinico Universitario A Gemelli IRCCS, Rome

85-163

NOT_YET_RECRUITING

Centrum Medyczne Neuromed, Bydgoszcz

32-600

NOT_YET_RECRUITING

NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis Lech Szczechowski, Katowice

20-412

NOT_YET_RECRUITING

Pro Life Medica Sp. z o. o. ETA Lublin, Lublin

02-699

NOT_YET_RECRUITING

Insula Badania Sp. Z o.o., Warsaw

08035

NOT_YET_RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

08036

NOT_YET_RECRUITING

Hospital Clinic de Barcelona (Hospital Clinic i Provincial) - Barnaclinic S.A., Barcelona

SW17 0QT

NOT_YET_RECRUITING

St George's Hospital, University of London, London

WC1N 3BG

NOT_YET_RECRUITING

University College London Hospitals NHS Foundation Trust, London

NE4 5PL

NOT_YET_RECRUITING

Clinical Aging Research Unit, Newcastle University, Newcastle upon Tyne

DD19SY

NOT_YET_RECRUITING

Ninewells Hospital and Medical School - NHS Tayside, Dundee

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Qiagen Manchester Limited

UNKNOWN

collaborator

Roche Diagnostic Ltd.

INDUSTRY

lead

Neuron23 Inc.

INDUSTRY

NCT06680830 - A Phase 2 Study of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease | Biotech Hunter | Biotech Hunter