23 Participants Needed

DSP-1083 for Parkinson's Disease

Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Sumitomo Pharma America, Inc.
Must be taking: L-DOPA, L-DOPA enhancers
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effects of a new treatment called DSP-1083 for individuals with Parkinson's disease. Participants will either receive the DSP-1083 implant or undergo a sham surgery, which mimics the procedure without delivering the treatment, to compare outcomes. The trial seeks individuals who have had Parkinson's for over 5 years and struggle to control symptoms despite medication. This offers a chance to explore new treatment options when current medications are insufficient. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should have been on an optimized oral antiparkinsonian medication regimen for at least 3 months, including L-DOPA and another medication that increases its effects.

Is there any evidence suggesting that DSP-1083 is likely to be safe for humans?

Research shows that DSP-1083, a treatment under study for Parkinson's disease, is in the early stages of human testing. Detailed safety information is not yet available. However, these early trials are crucial for understanding how well participants can tolerate the treatment.

As a Phase 1 trial, the primary focus is on safety and tolerance. Researchers closely monitor for any side effects and the body's response. Phase 1 trials typically involve a small number of participants to minimize risk while collecting essential data.

If DSP-1083 proves well-tolerated in this phase, it could lead to further studies with more participants. Currently, joining the trial contributes to the initial steps in assessing the safety of DSP-1083 for people.12345

Why do researchers think this study treatment might be promising?

DSP-1083 is unique because it involves the implantation of live cells directly into the brain, offering a novel approach for treating Parkinson's disease. Unlike current treatments like levodopa or dopamine agonists that primarily manage symptoms by boosting dopamine levels, DSP-1083 aims to potentially modify the disease by providing a direct cellular therapy. Researchers are excited because this could lead to longer-lasting improvements and potentially slow the progression of Parkinson's, which existing medications can't achieve.

What evidence suggests that DSP-1083 might be an effective treatment for Parkinson's Disease?

Research has shown that DSP-1083 could be a promising treatment for Parkinson's Disease. This trial will evaluate DSP-1083, which uses dopamine neural progenitor cells. These cells aim to replace the dopamine-producing cells lost in the brains of people with Parkinson's. Early results suggest that replacing these cells might improve symptoms by restoring dopamine levels. Although few studies have been conducted on humans, the approach is based on a solid scientific understanding of how Parkinson's affects the brain. The hope is that by directly addressing the loss of dopamine, DSP-1083 will help manage and reduce symptoms of Parkinson's Disease.13456

Are You a Good Fit for This Trial?

This trial is for men and women with Parkinson's Disease, specifically those who may also have dementia. Participants should be eligible to undergo a surgical procedure. The study excludes individuals based on certain medical conditions or treatments that could interfere with the trial.

Inclusion Criteria

Subject is approved by the Sponsor Eligibility Committee following review of all required information collected during Screening and prior to surgery on Day -1
My Parkinson's symptoms improve by at least 30% with L-DOPA, without other Parkinson's meds.
I am between 40 and 69 years old and have been diagnosed with Parkinson's disease.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Cohort 1 will receive 2 unilateral surgical procedures separated by approximately 28 weeks. Cohorts SS2 and SS3 will undergo bilateral implantation of DSP-1083 in a single surgical procedure.

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neuroimaging and cognitive assessments.

104 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • DSP-1083
Trial Overview The study is testing the effects of implanting a device called DSP-1083 in patients with Parkinson's Disease compared to a sham (fake) surgery. It aims to assess how safe and tolerable this treatment is, as well as its potential benefits.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DSP-1083Experimental Treatment1 Intervention
Group II: Sham SurgeryPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sumitomo Pharma America, Inc.

Lead Sponsor

Trials
244
Recruited
51,500+
Jatin Shah profile image

Jatin Shah

Sumitomo Pharma America, Inc.

Chief Medical Officer since 2024

MD from an unspecified institution

Tsutomu Nakagawa profile image

Tsutomu Nakagawa

Sumitomo Pharma America, Inc.

Chief Executive Officer since 2024

MBA from Waseda University

Published Research Related to This Trial

IRL790, a new treatment targeting the dopamine D3 receptor, was found to be safe and well-tolerated in a 4-week randomized controlled trial involving 15 Parkinson's disease patients with levodopa-induced dyskinesia, with no serious adverse events reported.
While the study showed a numeric reduction in dyskinesia symptoms, further research is needed to confirm its efficacy, and the findings will help shape future phase 2 studies.
Safety and tolerability of IRL790 in Parkinson's disease with levodopa-induced dyskinesia-a phase 1b trial.Svenningsson, P., Johansson, A., Nyholm, D., et al.[2020]
Safinamide significantly improves the duration of 'On-time' without dyskinesia in Parkinson's disease patients compared to a control group, with better outcomes observed at both 50 mg and 100 mg doses.
The treatment also leads to greater improvements in the Unified Parkinson's Disease Rating Scale Part III (UPDRSIII) scores, indicating enhanced motor function, while showing no significant difference in adverse events between safinamide and control groups, suggesting it is a safe option.
A meta-analysis of the effectiveness and safety of safinamide for levodopa-induced motor complications in Parkinson's disease.Li, J., Zhang, J., Meng, P.[2023]
In a study involving squirrel monkeys, the D3 receptor partial agonist BP897 was found to significantly reduce L-dopa-induced dyskinesias (LIDs), but this reduction came at the cost of diminishing the antiparkinsonian effects of L-dopa.
Unlike previous findings in macaques, BP897 did not maintain the therapeutic benefits of L-dopa while reducing dyskinesias in squirrel monkeys, suggesting that its effectiveness for treating LIDs in Parkinson's disease may be limited.
Effect of the D3 dopamine receptor partial agonist BP897 [N-[4-(4-(2-methoxyphenyl)piperazinyl)butyl]-2-naphthamide] on L-3,4-dihydroxyphenylalanine-induced dyskinesias and parkinsonism in squirrel monkeys.Hsu, A., Togasaki, DM., Bezard, E., et al.[2017]

Citations

Initiation of Company-sponsored Clinical Study on iPS Cell ...Parkinson's disease is a progressive neurodegenerative disease that is thought to be caused by a marked decrease in striatal dopamine levels due ...
DSP-1083 by Sumitomo Pharma for Parkinson's DiseaseAccording to GlobalData, Phase II drugs for Parkinson's Disease have a 41% phase transition success rate (PTSR) indication benchmark for ...
DSP-1083 for Parkinson's DiseaseSafinamide significantly improves the duration of 'On-time' without dyskinesia in Parkinson's disease patients compared to a control group, with better outcomes ...
Dopaminergic Cell Therapies for Parkinson DiseaseIn this post, I'll explore the current dopaminergic cell therapies in the pipeline, review the available clinical trial data, and address the ...
5 Promising Cell and Gene Therapies for Parkinson's ...DSP-1083 is currently in the Phase I/II stage of development for the treatment of Parkinson's disease. It consists of dopamine neural progenitor ...
A Multicenter Study to Evaluate Safety, Tolerability, and ...The goal of this study is to evaluate the safety, tolerability, and clinical responses following implantation of DSP-1083.
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