A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease
Purpose
This clinical trial is designed to test the safety and tolerability of the study intervention, RNDP-001, which will be implanted into the brain of study participants during a surgical procedure.
Conditions
- Idiopathic Parkinson´s Disease
- Parkinson's Disease
Eligibility
- Eligible Ages
- Between 45 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosis of idiopathic Parkinson's disease consistent with the Movement Disorders Society Clinical Criteria - Age 45 to 75 - Medically stable to undergo a surgical procedure
Exclusion Criteria
- Known Parkinson's disease gene mutation or variant - Previous infusion therapy or surgery for Parkinson's disease - History of allergic reaction or intolerance to an immunotherapeutic agent - Contraindication to MRI - Clinically significant medical conditions likely to interfere with the surgical procedure or study assessments
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental First patient group |
Low dose |
|
|
Experimental Second patient group |
High dose |
|
|
Experimental Third patient group |
Best dose |
|
Recruiting Locations
University of Arizona
Tucson 5318313, Arizona 5551752 85721
Tucson 5318313, Arizona 5551752 85721
Keck Medical Center of University of Southern California
Los Angeles 5368361, California 5332921 90033
Los Angeles 5368361, California 5332921 90033
The Ohio State University Wexner Medical Center
Columbus 4509177, Ohio 5165418 43210
Columbus 4509177, Ohio 5165418 43210
More Details
- NCT ID
- NCT07106021
- Status
- Recruiting
- Sponsor
- Kenai Therapeutics