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A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease
A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease
Active Not RecruitingPhase 1, Phase 2
Sponsor: Kenai Therapeutics
Conditions: Idiopathic Parkinson´s Disease, Parkinson's Disease
Interventions: RNDP-001, Syringe Front-Loading Device
Countries: United States
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.
Eligibility overview
Sex: ALL
Age: 45 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
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
Locations (3)
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Columbus, Ohio, United States