RecruitingPhase 1Phase 2NCT06753331

A Multicenter Study to Evaluate Safety, Tolerability, and Clinical Responses of DSP-1083 Into Subjects With Parkinson's Disease

A Multicenter, Sham-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Clinical Responses Following Stereotactic Intracranial Implantation of DSP-1083 Into Subjects With Parkinson's Disease


Sponsor

Sumitomo Pharma America, Inc.

Enrollment

25 participants

Start Date

Dec 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The Goal of this study is to evaluate the safety, tolerability, and clinical responses following implantation of DSP-1083. Study enrolls both male and female patients in 2 cohorts. This study will be held in approximately 5-8 study sites in United States


Eligibility

Min Age: 40 YearsMax Age: 72 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new investigational drug delivered directly into the brain via a small pump (similar to a pacemaker for Parkinson's) called continuous subcutaneous infusion, for people with moderate-to-advanced Parkinson's disease whose symptoms are no longer well-controlled by oral medications. **You may be eligible if...** - You are 40–72 years old with a confirmed Parkinson's disease diagnosis for at least 4 years - Your symptoms fluctuate between 'on' (controlled) and 'off' (uncontrolled) periods despite optimized oral medications - Your Parkinson's is in stage 3–4 (moderate to severe) when medications are 'off' - You have had a brain scan (18F-DOPA PET) consistent with Parkinson's disease - Your levodopa medication still provides at least 30% improvement in symptoms **You may NOT be eligible if...** - You have an atypical Parkinson's variant (such as progressive supranuclear palsy or multiple system atrophy) - You have had deep brain stimulation or another implanted brain device - You have significant dementia or psychiatric conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTDSP-1083 implantation

DSP-1083 subjects will receive 2.7M viable cells per hemisphere; 5.4M total cell dose as implants.

PROCEDURESham surgery treatment

Sham surgery subjects will undergo a partial thickness burr hole surgical procedure on each side of the skull with no DSP-1083 administration.


Locations(2)

University of Kentucky Medical Center

Lexington, Kentucky, United States

New York Presbyterian Hospital-Columbia University Medical Center

New York, New York, United States

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NCT06753331


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