RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 72 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 104 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Safety is measured based on adverse events, changes in neuropsychiatric/cognition status, and serial neuroimaging (ie, engraftment status, graft expansion, rejection) over 104 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of DSP-1083, a cell implant, and how well people handle it. It also looks at how Parkinson’s symptoms respond. It is for adults ages 40 to 72 who have had Parkinson’s disease for at least 4 years.

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 5-8 study sites in United States

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 40 to 72 and have a confirmed Parkinson’s diagnosis for at least 4 years.
  • Your symptoms are not well controlled despite the best use of Parkinson’s pills, including levodopa/carbidopa. Your doses have been stable for at least 2 months.
  • At screening, your symptoms improve by at least 30% with L-DOPA, tested without the effects of other Parkinson’s medicines.
  • Your Parkinson’s is stage 3 or 4 on the study’s rating scale during an “Off” period, when medicine is not working well.
  • A special brain scan called an 18F-DOPA PET scan shows findings that match Parkinson’s disease.
  • Study ratings and your daily diary show both “On” periods, when medicine works, and “Off” periods.
  • Two of the first group of up to 5 patients must have at least 2 Japanese, Taiwanese, Korean, or Chinese grandparents. The second group can include people of any race.
  • The study’s eligibility committee approves you after reviewing your screening results.

Who can't join

  • You have a different form of parkinsonism, a condition with symptoms like Parkinson’s disease.
  • You have another brain or nerve disease that prevents you from joining, based on your scans or health history.
  • You have mental health, memory, thinking, or behavior problems that the study doctor decides prevent you from joining.
  • You have had certain Parkinson’s treatments, such as deep-brain stimulation, surgery to destroy brain tissue, cell implants, gene therapy, or focused ultrasound.
  • You have uncontrolled movements called dyskinesia that meet the study’s severity limits, or another type or unusual pattern of these movements.
  • You have immune system problems that could affect the cell implants or use of medicines that lower immune activity.
  • Screening tests show low infection-fighting blood cells or platelets, high liver test results, lasting low kidney function, or poorly controlled diabetes.
  • You have a condition that makes anesthesia, sedation, or the brain surgery unsafe, or a serious unstable or long-term illness that could put you at risk or affect the results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. 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 for Parkinson's Disease. 2. Subject has a clinically established diagnosis of PD for ≥ 4 years. 3. 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 for ≥ 2months prior to screening. 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 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/IV and the Hauser patient daily diary. 8. Subjects must meet the following race criteria: 2 of the up to 5 sentinel subjects will be of Asian race, defined as having at least 2 grandparents who are Japanese, Taiwanese, Korean, or Chinese. Subjects in Cohort 2 can be of any race. 9. Subject is approved by the Enrollment Authorization Eligibility Committee following review of all required information collected during Screening. Exclusion Criteria: 1. 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 parkinsonism, secondary parkinsonism, hereditary parkinsonism). 2. 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 neurodegenerative disorder) based on neuroimaging and/or medical history that would preclude study participation. 3. Subject has psychiatric symptoms, cognitive impairment, depression, dementia, or other behavioral disorder that would preclude study participation based on Investigator decision. 4. 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 therapy, and/or focused ultrasound therapy. 5. 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 score of ≥ 2 (moderate dyskinesia) on Part 3 (Objective Evaluation of Dyskinesia Disability) Intensity Scale: Impairment. Subject has another type (eg, diphasic dyskinesia) or an unusual pattern of dyskinesia. 6. 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. 7. 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 subjects (glycosylated hemoglobin \> 9.0%, or fasting serum glucose ≥ 200mg/dL). 8. Subject has any disorder that would contraindicate general anesthesia, conscious sedation or stereotactic surgery. 9. 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 impact of the condition upon risk to subject or study results is unclear, the Medical Monitor should be consulted.

Study sites (2)

KY

NY