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

Sumitomo Pharma

Status and phase

Enrolling

Phase 1

Conditions

Parkinson's Disease

Treatments

Procedure: Sham surgery treatment

Combination Product: DSP-1083 implantation

Study type

Interventional

Funder types

Industry

Identifiers

NCT06753331

DD201101

Details and patient eligibility

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 5-6 study sites in North America

Full description

This is a multicenter first-in-human (FIH) study designed to evaluate the safety, tolerability, and clinical responses following implantation of DSP-1083 compared with sham surgery. Safety is measured based on adverse events, changes in neuropsychiatric/cognition status, and serial neuroimaging (ie, engraftment status, graft expansion, rejection) over 104 weeks.

SS1 Cohort 1 will receive 2 unilateral surgical procedures separated by approximately 28 weeks. SS2 and SS3 will undergobilateral implantation of DSP-1083 in a single surgical procedure.

Enrollment

23 estimated patients

Sex

All

Ages

40 to 69 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Men or women aged ≥ 40 and < 70 years with a clinically establisheddiagnosis of Parkinson's disease in accordance with the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease.
Subject has a diagnosis of PD for ≥ 5 years.
Subject has suboptimal control of PD symptoms, or intolerable side-effects with optimized oral antiparkinsonian medication regimen for ≥ 3 months, including treatment with L-DOPA and at least one medication that increases the effects of L-DOPA .
Subject has a L-DOPA response of ≥ 30% without the influence of antiparkinsonian medications at Screening.
Subject has a Modified Hoehn and Yahr stage 3 - 4 in the Off medication state.
Subject has a pretreatment 18F-DOPA PET scan consistent with PD.
Subject has both On and Off states as demonstrated by the MDS-UPDRS Part III and the Hauser patient daily diary.
Subject must meet the following ethnicity criteria:
- SS1 will either be Asian defined as having both parents and 4 grandparents who are ethnically Asian, or non-Asian.
- SS2 and SS3 will be Asian defined as having both parents and 4 grandparents who are ethnically Asian.
- Cohort 2 subjects will be of any ethnicity.
Subject is approved by the Sponsor Eligibility Committee following review of all required information collected during Screening and prior to surgery on Day -1.