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

Last updated: April 30, 2025
Sponsor: Sumitomo Pharma America, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Parkinson's Disease

Dyskinesias

Treatment

DSP-1083 implantation

Sham surgery treatment

Clinical Study ID

NCT06753331
DD201101
  • Ages 40-69
  • All Genders

Study 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 5-6 study sites in North America

Eligibility Criteria

Inclusion

  1. 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.

  2. Subject has a diagnosis of PD for ≥ 5 years.

  3. 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 .

  4. Subject has a L-DOPA response of ≥ 30% without the influence of antiparkinsonian medications at Screening.

  5. Subject has a Modified Hoehn and Yahr stage 3 - 4 in the Off medication state.

  6. Subject has a pretreatment 18F-DOPA PET scan consistent with PD.

  7. Subject has both On and Off states as demonstrated by the MDS-UPDRS Part III and the Hauser patient daily diary.

  8. 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.

  1. Subject is approved by the Sponsor Eligibility Committee following review of all required information collected during Screening and prior to surgery on Day -1.

Study Design

Total Participants: 23
Treatment Group(s): 2
Primary Treatment: DSP-1083 implantation
Phase: 1
Study Start date:
December 18, 2024
Estimated Completion Date:
March 01, 2029

Study 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.

Connect with a study center

  • University of Kentucky Medical Center

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • New York Presbyterian Hospital-Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

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