Lexington, KYNCT06753331Now EnrollingIRB Ready

Parkinson's Disease Clinical Trial in Lexington, KY

Access cutting-edge parkinson's disease treatment through this clinical trial at a research site in Lexington. Study-provided care at no cost to qualified participants.

Sponsored by Sumitomo Pharma America, Inc.

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Expert Care in Lexington

Access parkinson's disease specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related parkinson's disease treatment provided free

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Check if you qualify for this parkinson's disease clinical trial in Lexington, KY

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Why Participate?

  • No-Cost Study Care

  • Local to Lexington

    Convenient for KY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Lexington site if eligible
  4. 4Begin participation

About This Parkinson's Disease Study in Lexington

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

Sponsor: Sumitomo Pharma America, Inc.

Who Can Participate

Inclusion 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 for Parkinson's Disease.
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 for ≥ 2months prior to screening.
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.
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.
Subject is approved by the Enrollment Authorization Eligibility Committee following review of all required information collected during Screening.

Exclusion Criteria

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).
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.
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 therapy, and/or focused ultrasound therapy.
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.
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 subjects (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 impact of the condition upon risk to subject or study results is unclear, the Medical Monitor should be consulted.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Lexington?

Yes, this clinical trial (NCT06753331) has an active research site in Lexington, KY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Parkinson's Disease Treatment Options in Lexington, KY

If you're searching for parkinson's disease treatment options in Lexington, KY, this clinical trial (NCT06753331) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Lexington research site is actively enrolling participants for this clinical trial. You'll receive care from experienced parkinson's disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all parkinson's disease clinical trials near you to find additional studies recruiting in your area.

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