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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 January 2025
• Main ID: NCT06753331
• Date of registration: 19/11/2024
• Prospective Registration: Yes
• Primary sponsor: Sumitomo Pharma America, Inc.
• Public title: A Multicenter Study to Evaluate Safety, Tolerability, and Clinical Responses of DSP-1083 Into Subjects with Parkinson's Disease
• Scientific title: A Multicenter, Sham-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Clinical Responses Following Stereotactic Intracranial Implantation of DSP-1083 Into Subjects with Parkinson's Disease
• Date of first enrolment: December 18, 2024
• Target sample size: 23
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT06753331
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Lynne Cagle

Key inclusion & exclusion criteria

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.

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


Age minimum: 40 Years
Age maximum: 69 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Combination Product: DSP-1083 implantation

Procedure: Sham surgery treatment

Primary Outcome(s)

Incidence and severity of Adverse Events of Special Interest (AESI). [Time Frame: Up to 104 weeks]

Change from baseline in Head Magnetic Resonance Imaging (MRI) (graft expansion/rejection) neuroimaging parameters. [Time Frame: Up to 104 weeks]

Incidence of Serious Adverse Events (SAE). [Time Frame: Up to 104 weeks]

Observed values and change from baseline in PR interval. [Time Frame: Up to 104 weeks]

Incidence and severity of Adverse Events. [Time Frame: Up to 104 weeks]

Observed values and change from baseline in QRS duration. [Time Frame: Up to 104 weeks]

Change from baseline in cognition and neuropsychiatric status as assessed by Montreal Cognitive Assessment (MoCA). [Time Frame: Up to 104 weeks]

Frequency of subjects with suicidal ideation or suicidal behavior using the Columbia Suicide Severity Scale (C-SSRS). [Time Frame: Up to 104 weeks]

Incidence and severity of Adverse Events leading to study discontinuation. [Time Frame: Up to 104 weeks]

Observed values and change from baseline in RR interval. [Time Frame: Up to 104 weeks]

Change from baseline in Fluorodopa (F-DOPA) uptake (graft function) neuroimaging parameters. [Time Frame: Up to 104 weeks]

Observed values and change from baseline in Heart Rate (HR). [Time Frame: Up to 104 weeks]

Observed values and change from baseline in pulse rate. [Time Frame: Up to 104 weeks]

Observed values and change from baseline in Diastolic Blood Pressure. [Time Frame: Up to 104 weeks]

Change from baseline in cognition and neuropsychiatric status as assessed by Mattis Dementia Rating Scale (MDRS). [Time Frame: Up to 104 weeks]

Observed values and change from baseline in body temperature. [Time Frame: Up to 104 weeks]

Observed values and change from baseline in clinical laboratory tests. [Time Frame: Up to 104 weeks]

Observed values and change from baseline in QTcF interval. [Time Frame: Up to 104 weeks]

Observed values and change from baseline in QT interval. [Time Frame: Up to 104 weeks]

Observed values and change from baseline in Systolic Blood Pressure. [Time Frame: Up to 104 weeks]

Observed values and change from baseline in respiratory rate. [Time Frame: Up to 104 weeks]

Secondary ID(s)

DD201101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors