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Tests treatment safety and results for Parkinson's Disease
Official title A Multicenter Study to Evaluate Safety, Tolerability, and Clinical Responses of DSP-1083 Into Subjects With Parkinson's Disease
ClinicalTrials.gov ID: NCT06753331
What this study is testing
What is DSP-1083 implantation?
DSP-1083 implantation is an investigational medicine, being studied as a potential treatment for parkinson's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 104 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 72
You may be able to join if
- Men or women aged ≥ 40 and ≤ 72 years at the time of informed consent with a clinically established diagnosis of Parkinson's disease in accordance...
- Subject has a clinically established diagnosis of PD for ≥ 4 years.
- Subject has suboptimal control of PD symptoms, with optimized oral antiparkinsonian medication regimen including levodopa/carbidopa monotherapy or...
- 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 state.
You likely can't join if
- Subject has atypical parkinsonian syndrome (eg, progressive supranuclear palsy [PSP], multiple system atrophy [MSA], dementia with Lewy bodies [DLB]...
- Subject has non-PD neurological symptoms or evidence of non-PD brain disease (eg, tumor, inflammation, active or history of vascular disorder...
- Subject has psychiatric symptoms, cognitive impairment, depression, dementia, or other behavioral disorder that would preclude study participation...
- Subject has received previous striatal or other extrapyramidal system PD treatments, including deep-brain stimulation, central nervous system (CNS)...
- Subject has peak-dose dyskinesia of sufficient severity that precludes study participation, defined as any item score of ≥ 3 (moderate dyskinesia) on...
- Subject has a history of, or concurrent abnormal immune function that may adversely affect the engraftment of the cell implants and use of adjunctive...
See the full eligibility criteria
- Men or women aged ≥ 40 and ≤ 72 years at the time of informed consent with a clinically established diagnosis of Parkinson's disease in accordance with the Movement Disorder Society (MDS) Clinical Diagnostic Criteria...
- Subject has a clinically established diagnosis of PD for ≥ 4 years.
- Subject has suboptimal control of PD symptoms, with optimized oral antiparkinsonian medication regimen including levodopa/carbidopa monotherapy or levodopa/carbidopa plus antiparkinsonian medications, with stable dosing...
- 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 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/IV and the Hauser patient daily diary.
- people must meet the following race criteria: 2 of the up to 5 sentinel people will be of Asian race, defined as having at least 2 grandparents who are Japanese, Taiwanese, Korean, or Chinese. people in Cohort 2 can be...
- Subject is approved by the Enrollment Authorization Eligibility Committee following review of all required information collected during Screening.
- Subject has atypical parkinsonian syndrome (eg, progressive supranuclear palsy [PSP], multiple system atrophy [MSA], dementia with Lewy bodies [DLB], corticobasal degeneration, Parkinson-plus syndrome, vascular...
- Subject has non-PD neurological symptoms or evidence of non-PD brain disease (eg, tumor, inflammation, active or history of vascular disorder, history of cerebral hemorrhage, Alzheimer's disease, or other...
- Subject has psychiatric symptoms, cognitive impairment, depression, dementia, or other behavioral disorder that would preclude study participation based on Investigator decision.
- Subject has received previous striatal or other extrapyramidal system PD treatments, including deep-brain stimulation, central nervous system (CNS) ablation (eg, pallidotomy, thalamotomy), implanted cell, or gene...
- Subject has peak-dose dyskinesia of sufficient severity that precludes study participation, defined as any item score of ≥ 3 (moderate dyskinesia) on the UDysRS Part 1B (Patient Dyskinesia Questionnaire) AND/OR any item...
- Subject has a history of, or concurrent abnormal immune function that may adversely affect the engraftment of the cell implants and use of adjunctive immunosuppressants.
- The subject has the following clinical laboratory test results at Screening:
- Neutrophil count \< 2,000/μL.
- Platelet count \< 5.0 × 104/μL.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 3.0 × upper limit of normal.
- Total bilirubin \> 1.5 × upper limit of normal.
- Persistent estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2.
- Poorly controlled blood glucose in diabetic people (glycosylated hemoglobin \> 9.0%, or fasting serum glucose ≥ 200mg/dL).
- Subject has any disorder that would contraindicate general anesthesia, conscious sedation or stereotactic surgery.
- Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that would pose a risk to the subject or that might confound the results of the study. In cases in which...
The study team makes the final eligibility decision.
Where it's taking place
- Lexington, Kentucky, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 104 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 72 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lexington, Kentucky, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.