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

Sumitomo Pharma America, Inc.
NCT IDNCT06753331ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1/2

Target enrollment

25

Study length

about 6 years

Ages

40–72

Locations

2 sites in KY, NY

About this study

Researchers are testing the safety and tolerability of a treatment called DSP-1083 in people with Parkinson's disease. The trial will also evaluate how well this treatment works clinically. It involves implanting DSP-1083 or performing sham surgery on participants.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Undergo Sham surgery treatment
  • 2.Use DSP-1083 implantation
PhasePhase 1/Phase 2
Primary goalChange from baseline in Fluorodopa (F-DOPA) uptake (graft function) neuroimaging parameters

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low11%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Endpoints

Primary: Change from baseline in Fluorodopa (F-DOPA) uptake (graft function) neuroimaging parameters., Change from baseline in Head Magnetic Resonance Imaging (MRI) (graft expansion/rejection) neuroimaging parameters., Change from baseline in cognition and neuropsychiatric status as assessed by Mattis Dementia Rating Scale (MDRS)., Change from baseline in cognition and neuropsychiatric status as assessed by Montreal Cognitive Assessment (MoCA)., Incidence and severity of Adverse Events leading to study discontinuation., Incidence and severity of Adverse Events of Special Interest (AESI)., Incidence and severity of Adverse Events., Incidence of Serious Adverse Events (SAE).

Procedures

surgery

Body systems

Neurology