Actively Recruiting
A Multicenter Study to Evaluate Safety, Tolerability, and Clinical Responses of DSP-1083 Into Subjects With Parkinson's Disease
Led by Sumitomo Pharma America, Inc. · Updated on 2026-03-02
25
Participants Needed
2
Research Sites
312 weeks
Total Duration
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AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Multicenter Study to Evaluate Safety, Tolerability, and Clinical Responses of DSP-1083 Into Subjects With Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 40 to 72 years with a clinical diagnosis of Parkinson's Disease according to Movement Disorder Society criteria
- Parkinson's Disease diagnosed for at least 4 years
- Suboptimal control of Parkinson's Disease symptoms on stable oral antiparkinsonian medication for at least 2 months
- L-DOPA response of 30% or more without influence of other antiparkinsonian drugs at screening
- Modified Hoehn and Yahr stage 3 to 4 in the Off state
- Pretreatment 18F-DOPA PET scan consistent with Parkinson's Disease
- Presence of both On and Off motor states as shown by clinical assessments and patient diaries
- Race criteria for sentinel subjects: at least 2 grandparents of Asian descent (Japanese, Taiwanese, Korean, or Chinese); no race restriction for Cohort 2
- Approval by Enrollment Authorization Eligibility Committee after screening
You will not qualify if you...
- Atypical parkinsonian syndromes such as PSP, MSA, DLB, corticobasal degeneration, Parkinson-plus syndrome, vascular or secondary parkinsonism, hereditary parkinsonism
- Non-Parkinson's neurological symptoms or brain diseases including tumors, inflammation, vascular disorders, cerebral hemorrhage, Alzheimer's, or other neurodegenerative diseases
- Psychiatric symptoms, cognitive impairment, depression, dementia, or behavioral disorders preventing participation
- Prior PD treatments including deep-brain stimulation, CNS ablation, implanted cell or gene therapy, or focused ultrasound
- Severe peak-dose dyskinesia as defined by specific questionnaire scores or unusual dyskinesia patterns
- History or current abnormal immune function affecting graft acceptance or requiring immunosuppressants
- Laboratory abnormalities: neutrophils < 2000/µL, platelets < 5.0 × 10⁴/µL, AST or ALT > 3× upper limit normal, bilirubin > 1.5× upper limit normal, eGFR < 60 mL/min/1.73 m², poorly controlled diabetes (HbA1c > 9.0%, fasting glucose ≥ 200 mg/dL)
- Conditions contraindicating general anesthesia, conscious sedation, or stereotactic surgery
- Clinically significant unstable medical or chronic conditions posing risk or confounding study results; consult Medical Monitor if unclear
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
2
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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