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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

NCT07106021

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