Status:
RECRUITING
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Lead Sponsor:
Neuron23 Inc.
Collaborating Sponsors:
Qiagen Manchester Limited
Roche Diagnostic Ltd.
Conditions:
Parkinson Disease
Parkinson
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 measur...
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Additional inclusion and exclusion criteria for the RCP and OLE are outlined in the full study protocol.
Key Trial Info
Start Date :
January 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06680830
Start Date
January 17 2025
End Date
September 1 2027
Last Update
April 13 2026
Active Locations (70)
Enter a location and click search to find clinical trials sorted by distance.
1
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
2
University of Arkansas
Little Rock, Arkansas, United States, 72205
3
Neuro-Pain Medical Center
Fresno, California, United States, 93710
4
University of California, Irvine
Irvine, California, United States, 92697