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

Phase 1

Recruiting

• Conditions: Parkinson's Disease

• Registration Number: NCT06753331
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2024-11-19
• Study Start: 2024-12-18
• Study First Submitted QC: 2024-12-20
• Study First Posted: 2024-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2029-03-01
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence and severity of Adverse Events.	Up to 104 weeks
Incidence of Serious Adverse Events (SAE).	Up to 104 weeks
Incidence and severity of Adverse Events of Special Interest (AESI).	Up to 104 weeks
Incidence and severity of Adverse Events leading to study discontinuation.	Up to 104 weeks
Change from baseline in cognition and neuropsychiatric status as assessed by Montreal Cognitive Assessment (MoCA).	Up to 104 weeks	The MoCA is a widely used, sensitive, validated screening test for detecting mild cognitive impairment and can also predict the presence of cognitive deterioration (ie, progression from mild cognitive impairment to dementia) in PD patients.
Change from baseline in cognition and neuropsychiatric status as assessed by Mattis Dementia Rating Scale (MDRS).	Up to 104 weeks	The MDRS has been utilized for early detection of dementia, differential diagnosis between Alzheimer's disease and other dementias. The 144-point scale is an aggregate score of 5 subscales: attention, initiation/perseveration (I/P), construction, conceptualization, and memory.The total score ranges from 0 to 144, with lower scores indicating greater cognitive impairment.
Change from baseline in Head Magnetic Resonance Imaging (MRI) (graft expansion/rejection) neuroimaging parameters.	Up to 104 weeks	Safety MRIs - are conducted to assess the safety of DSP-1083 including rejection, abnormal growth, and formation of mass lesions, which could indicate teratoma formation
Change from baseline in Fluorodopa (F-DOPA) uptake (graft function) neuroimaging parameters.	Up to 104 weeks	PET scans using F-DOPA will be performed at Screening and then post-surgery to follow the course of graft development and to provide a measure of dopaminergic nerve terminals in the striatum.
Frequency of subjects with suicidal ideation or suicidal behavior using the Columbia Suicide Severity Scale (C-SSRS).	Up to 104 weeks
Observed values and change from baseline in clinical laboratory tests.	Up to 104 weeks	Laboratory results at each time point will be summarized using descriptive statistics (mean, standard deviation (SD), median, minimum, and maximum) by treatment group.
Observed values and change from baseline in Heart Rate (HR).	Up to 104 weeks	12-lead ECG parameters ventricular HR at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Observed values and change from baseline in QT interval.	Up to 104 weeks	12-lead ECG parameters QT interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Observed values and change from baseline in PR interval.	Up to 104 weeks	12-lead ECG parameters PR interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Observed values and change from baseline in QRS duration.	Up to 104 weeks	12-lead ECG parameters QRS duration at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Observed values and change from baseline in RR interval.	Up to 104 weeks	12-lead ECG parameters RR interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Observed values and change from baseline in QTcF interval.	Up to 104 weeks	12-lead ECG parameters QTcF interval at each time point will be summarized by treatment group. All ECG diagnostic findings will be summarized on the basis of incidence rates by treatment group.
Observed values and change from baseline in body temperature.	Up to 104 weeks	Vital signs parameter body temperature will be summarized using descriptive statistics at each time point by treatment group.
Observed values and change from baseline in respiratory rate.	Up to 104 weeks	Vital signs parameter supine respiratory rate will be summarized using descriptive statistics at each time point by treatment group.
Observed values and change from baseline in pulse rate.	Up to 104 weeks	Vital signs parameter supine and standing pulse will be summarized using descriptive statistics at each time point by treatment group.
Observed values and change from baseline in Systolic Blood Pressure.	Up to 104 weeks	Vital signs parameter Systolic Blood Pressure will be summarized using descriptive statistics at each time point by treatment group.
Observed values and change from baseline in Diastolic Blood Pressure.	Up to 104 weeks	Vital signs parameter Diastolic Blood Pressure will be summarized using descriptive statistics at each time point by treatment group.

Trial Locations

Locations (2)

New York Presbyterian Hospital-Columbia University Medical Center; 🇺🇸 New York, New York, United States

University of Kentucky Medical Center; 🇺🇸 Lexington, Kentucky, United States