A Multicenter Trial to Evaluate Safety, Tolerability, and Clinical Responses of DSP-1083 Into Subjects With Parkinson's Disease
Phase 1/2
25
about 6 years
40–72
2 sites in KY, NY
What this study is about
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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Undergo Sham surgery treatment
- 2.Use DSP-1083 implantation
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
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).
surgery
Neurology