Clinical trial • Phase II • Neurology

NEU-411 MALEATE for Parkinson's disease | Early Parkinson's disease | Idiopathic Parkinson's disease

Phase II trial of NEU-411 MALEATE for Parkinson's disease | Early Parkinson's disease | Idiopathic Parkinson's disease.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Parkinson's disease | Early Parkinson's disease | Idiopathic Parkinson's disease
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
27-01-2025
First CTIS Authorization Date
19-05-2025

Trial design

Randomised, neu-411 (orally-administered; product record lists max daily dose 30 mg) compared to matching placebo (placebo neu-411 maleate; no dose specified).-controlled Phase II trial in Spain, Italy, Poland.

Randomised
Yes
Comparator
NEU-411 (orally-administered; product record lists max daily dose 30 mg) compared to matching Placebo (Placebo NEU-411 maleate; no dose specified).
Biomarker Stratified
True; biomarker: LRRK2-pathway activity / LRRK2 genetic test (investigational companion diagnostic CDx) used to select CDx-positive participants
Target Sample Size
90
Trial Duration For Participant
378

Stratification factors

  • Age

Eligibility

Recruits 90 isVulnerablePopulationSelected: true. Subject information and informed consent forms are listed in the submitted documents (L1_SIS and ICF documents available in multiple versions/languages). No further details on assent/consent handling for vulnerable populations are available in the provided data..

Vulnerable Population
isVulnerablePopulationSelected: true. Subject information and informed consent forms are listed in the submitted documents (L1_SIS and ICF documents available in multiple versions/languages). No further details on assent/consent handling for vulnerable populations are available in the provided data.

Inclusion criteria

  • {"criterion_text":"- Aged 40-80 years at time of screening, inclusive\n- Diagnosis of clinically established or clinically probable Parkinson's disease\n- LRRK2-driven PD using the investigational companion diagnostic genetic test (CDx)\n- Modified Hoehn and Yahr (mH&Y) of 1 to 2.5\n- Additional inclusion criteria are outlined in the full study protocol."}

Exclusion criteria

  • {"criterion_text":"- Secondary or atypical parkinsonian syndromes\n- Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) >8%\n- Other significant medical conditions (as determined by medical history, examination, or clinical investigations at screening)\n- Additional exclusion criteria are outlined in the full study protocol."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo Time Frame: From enrollment to the end of treatment at 52 weeks","definition_or_measurement_approach":"Measured as change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0); time frame: from enrollment to end of treatment at 52 weeks."}
  • {"endpoint_text":"- Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo Time Frame: From enrollment to the end of study at 54 weeks","definition_or_measurement_approach":"Count and comparison of TEAEs and SAEs between arms; time frame: from enrollment to end of study at 54 weeks."}

Secondary endpoints

  • {"endpoint_text":"- 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)","definition_or_measurement_approach":"Change from baseline to Week 52 measured using MDS-UPDRS total or specified subscales as defined in study protocol."}

Recruitment

Planned Sample Size
90
Recruitment Window Months
24
Consent Approach
Informed consent is obtained from participants. Subject information sheets and informed consent forms (L1_SIS and ICF) are available in multiple languages (EN, ES, IT, PL) as listed in submitted documents. Additional optional ICFs (e.g., lumbar puncture, pregnant partner) are listed. No further details on assent or specific consent procedures are available in the provided data.

Geography

Total Number Of Sites
21
Total Number Of Participants
60

Spain

Earliest CTIS Part Ii Submission Date
28-03-2025
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
241
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Policlinica Gipuzkoa S.A.
Department Name
Neurology
Principal Investigator Name
GURUTZ LINAZASORO
Principal Investigator Email
glinazasoro@vivebiotech.com
Contact Person Name
GURUTZ LINAZASORO
Contact Person Email
glinazasoro@vivebiotech.com
Site Name
Hospital Clinic De Barcelona
Department Name
Neurology
Principal Investigator Name
ALICIA GARRIDO
Principal Investigator Email
AGARRIDOP@CLINIC.CAT
Contact Person Name
ALICIA GARRIDO
Contact Person Email
AGARRIDOP@CLINIC.CAT
Site Name
Hospital Universitario Virgen del Rocio
Department Name
Neurology
Principal Investigator Name
Pablo Mir
Principal Investigator Email
pmir@us.es
Contact Person Name
Pablo Mir
Contact Person Email
pmir@us.es
Site Name
Biocruces Bizkaia Health Research Center Institute
Department Name
Neurology
Principal Investigator Name
Juan Carlos Gomez
Principal Investigator Email
juancarlos.gomezesteban@osakidetza.eus
Contact Person Name
Juan Carlos Gomez
Site Name
Hospital Universitario De La Princesa
Department Name
Neurology
Principal Investigator Name
Lydia Lydia
Principal Investigator Email
lydialopez@hotmail.com
Contact Person Name
Lydia Lydia
Contact Person Email
lydialopez@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurology
Principal Investigator Name
Jorge Vara
Principal Investigator Email
jorge.hernandez@vallhebron.cat
Contact Person Name
Jorge Vara
Contact Person Email
jorge.hernandez@vallhebron.cat
Site Name
Hospital Universitario Hm Puerta Del Sur
Department Name
CINAC
Principal Investigator Name
Michele Matarazzo
Principal Investigator Email
mmatarazzo.hmcinac@hmhospitales.com
Contact Person Name
Michele Matarazzo

Italy

Earliest CTIS Part Ii Submission Date
01-05-2025
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
270
Number Of Sites
10
Number Of Participants
20

Sites

Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Neurology
Principal Investigator Name
Alessandro Tessitore
Principal Investigator Email
Alessandro.Tessitore@unicampania.it
Contact Person Name
Alessandro Tessitore
Site Name
ASST Spedali Civili di Brescia
Department Name
Neurology
Principal Investigator Name
Alessandro Padovani
Principal Investigator Email
Alessandro.Padovani@unibs.it
Contact Person Name
Alessandro Padovani
Contact Person Email
Alessandro.Padovani@unibs.it
Site Name
AOU Policlinico-San Marco
Department Name
Clinica Neurologica
Principal Investigator Name
Mario Zappia
Principal Investigator Email
m.zappia@unict.it
Contact Person Name
Mario Zappia
Contact Person Email
m.zappia@unict.it
Site Name
Ospedale Santa Chiara
Department Name
Neurology
Principal Investigator Name
Roberto Ceravolo
Principal Investigator Email
Roberto.Ceravolo@unipi.it
Contact Person Name
Roberto Ceravolo
Contact Person Email
Roberto.Ceravolo@unipi.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Neurology
Principal Investigator Name
Anna Bentivoglio
Principal Investigator Email
annarita.bentivoglio@policlinogemelli.it
Contact Person Name
Anna Bentivoglio
Site Name
Irccs San Raffaele Roma S.r.l.
Department Name
Neurology
Principal Investigator Name
Massimo Filippi
Principal Investigator Email
Filippi.Massimo@hsr.it
Contact Person Name
Massimo Filippi
Contact Person Email
Filippi.Massimo@hsr.it
Site Name
Istituto Neurologico Mediterraneo Neuromed S.p.A.
Department Name
Neurology
Principal Investigator Name
Diego Centonze
Principal Investigator Email
Centonze@uniroma2.it
Contact Person Name
Diego Centonze
Contact Person Email
Centonze@uniroma2.it
Site Name
Irccs San Raffaele Roma S.r.l.
Department Name
Neurology
Principal Investigator Name
Fabrizio Stocchi
Principal Investigator Email
Fabrizio.Stocchi@sanraffaele.it
Contact Person Name
Fabrizio Stocchi
Site Name
Universita Degli Studi Di Padova
Department Name
Neurology
Principal Investigator Name
Angelo Antonini
Principal Investigator Email
Angelo.Antonini@unipd.it
Contact Person Name
Angelo Antonini
Contact Person Email
Angelo.Antonini@unipd.it
Site Name
Universita' Degli Studi G. D'Annunzio Di Chieti
Department Name
Centro di Ricerca Clinica
Principal Investigator Name
Astrid Thomas
Principal Investigator Email
athomas@unich.it
Contact Person Name
Astrid Thomas
Contact Person Email
athomas@unich.it

Poland

Earliest CTIS Part Ii Submission Date
01-05-2025
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
292
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Centrum Medyczne Neuromed Sp. z o.o.
Department Name
Neurology
Principal Investigator Name
Pawel Lisewski
Principal Investigator Email
Lisewski.P@gmail.com
Contact Person Name
Pawel Lisewski
Contact Person Email
Lisewski.P@gmail.com
Site Name
Insula Badania Sp. z o.o.
Department Name
Neurology
Principal Investigator Name
Marta Jethon
Principal Investigator Email
jethon2@tlen.pl
Contact Person Name
Marta Jethon
Contact Person Email
jethon2@tlen.pl
Site Name
Pro Life Medica Sp. z o.o.
Department Name
Neurology
Principal Investigator Name
Dominika Tomaka
Principal Investigator Email
d.tomaka@etg-network.com
Contact Person Name
Dominika Tomaka
Contact Person Email
d.tomaka@etg-network.com
Site Name
Neurologiczny NZOZ Centrum Leczenia SM Ośrodek Badań Klinicznych im. dr n. med. Hanki Hertmanowskiej
Department Name
Neurology
Principal Investigator Name
KATARZYNA SMIŁOWSKA
Principal Investigator Email
Kasia.Smilowska@gmail.com
Contact Person Name
KATARZYNA SMIŁOWSKA
Contact Person Email
Kasia.Smilowska@gmail.com

Sponsor

Primary sponsor

Full Name
Neuron23 Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Rho Inc.
Responsibilities
sponsorDuties codes: 1,12,13,5,6,7,8

Third parties

  • {"country":"United States","full_name":"Rho Inc.","duties_or_roles":"sponsorDuties codes: 1,12,13,5,6,7,8","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
NEU-411
Active Substance
NEU-411 MALEATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Investigational medicinal product (IMP)
Maximum Dose
30 mg (max daily dose)
Investigational Product Name
Placebo NEU-411 maleate
Modality
Other
Authorisation Status
Placebo (investigational comparator)

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