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

ConditionsParkinson DiseaseParkinsonIdiopathic Parkinson DiseaseEarly Parkinson Disease (Early PD)Parkinson Disease, Idiopathic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorNeuron23 Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 40-80 years at time of screening, inclusive

Diagnosis of clinically established or clinically probable Parkinson's Disease (PD)

LRRK2-driven PD using the investigational companion diagnostic genetic test (CDx)

Modified Hoehn and Yahr (mH&Y) of 1 to 2.5

Disqualifiers

Secondary or atypical parkinsonian syndromes

Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) >8%

Other significant medical conditions (as determined by medical history, examination, or clinical investigations at screening)

Trial design

Design model

Parallel

Treatments tested in this trial

  • NEU-411

    Drug

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

  • Placebo

    Other intervention

    Orally-administered matched placebo

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: NEU-411Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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)

Time frame
52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Neuron23 Inc.

Lead sponsor

Qiagen Manchester Limited

Collaborator

Roche Diagnostic Ltd.

Collaborator

Source ClinicalTrials.gov
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