DSP-1083 for Parkinson's Disease

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Sumitomo Pharma America, Inc.

Must be taking: L-DOPA, L-DOPA enhancers

Disqualifiers: Under 40, Over 70, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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 5-6 study sites in North America

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.

What safety data exists for DSP-1083 or similar treatments in humans?

The research articles provided do not mention DSP-1083 specifically, but they discuss other treatments for Parkinson's Disease. Safinamide and sarizotan were found to be safe in trials, with no significant difference in adverse events compared to placebo. IRL790 was also found to be safe, with no serious adverse events reported. ^{1 2 3 4 5}

How does the drug DSP-1083 differ from other treatments for Parkinson's Disease?

DSP-1083 is unique because it targets the D3 dopamine receptor, which is involved in managing involuntary movements caused by L-dopa treatment in Parkinson's Disease. This approach is different from standard treatments that primarily focus on dopamine replacement. ^{4 6 7 8 9}

Research Team

Eligibility Criteria

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

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.

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

Trial Timeline

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

Treatment Details

Interventions

• DSP-1083 (Procedure)

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.

Participant Groups

Group I: DSP-1083 Experimental Treatment 1 Intervention

Implantation of DSP-1083 (2.7M viable cells per hemisphere; 5.4M total cell dose)

Group II: Sham Surgery Placebo Group 1 Intervention

Sham surgery subjects will undergo a partial thickness burr hole surgical procedure on each side of the skull with no DSP-1083 administration.

Who Is Running the Clinical Trial?

Sumitomo Pharma America, Inc.

Lead Sponsor

Trials

244

Recruited

51,500+

Jatin Shah

Sumitomo Pharma America, Inc.

Chief Medical Officer since 2024

MD from an unspecified institution

Tsutomu Nakagawa

Sumitomo Pharma America, Inc.

Chief Executive Officer since 2024

MBA from Waseda University

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Sarizotan at a dose of 2 mg/day is considered safe for Parkinson's disease patients with dyskinesia, showing significant improvement in the composite score of UPDRS Items 32+33, which measures dyskinesia duration and disability.

The study, which included 398 participants, found no significant changes in diary-based measures of dyskinesia or the AIMS score compared to placebo, indicating that while sarizotan may have some benefits, further research is needed to confirm its efficacy in reducing dyskinesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sarizotan as a treatment for dyskinesias in Parkinson's disease: a double-blind placebo-controlled trial. Goetz, CG., Damier, P., Hicking, C., et al.[2012]

The D3 dopamine receptor antagonist PG01037 showed potential in reducing L-dopa-associated abnormal involuntary movements (AIMs) in a rat model of Parkinson's Disease, particularly when administered intraperitoneally shortly after L-dopa treatment.

PG01037 did not negatively impact motor coordination or significantly reduce the beneficial effects of L-dopa, suggesting it could be a safe and effective option for managing dyskinesia in patients with Parkinson's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the D3 dopamine receptor selective antagonist PG01037 on L-dopa-dependent abnormal involuntary movements in rats. Kumar, R., Riddle, L., Griffin, SA., et al.[2021]

A panel of D3 dopamine receptor selective compounds, particularly WC 10, showed promise in reducing L-dopa-associated abnormal involuntary movements (AIMs) in a rat model of Parkinson's Disease, indicating their potential as therapeutic agents for L-dopa-induced dyskinesia.

The efficacy of these D3 receptor compounds was enhanced when administered alongside L-dopa, and notably, the D3 receptor agonist WC 44 did not induce abnormal involuntary movements, suggesting a safer profile compared to other dopamine receptor agonists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of D2 and D3 dopamine receptor selective compounds on L-dopa-dependent abnormal involuntary movements in rats. Kumar, R., Riddle, LR., Griffin, SA., et al.[2021]

5-HT3 antagonists like ondansetron and granisetron can reduce l-DOPA induced dyskinesia in animal models without affecting the drug's ability to alleviate Parkinson's symptoms, suggesting a potential therapeutic strategy for managing side effects of l-DOPA.

Increased binding of the 5-HT3 receptor in specific brain regions of hemi-parkinsonian rats correlates with the severity of abnormal involuntary movements, indicating that changes in 5-HT3 neurotransmission may play a role in the development of dyskinesia associated with l-DOPA treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autoradiographic labelling of 5-HT3 receptors in the hemi-parkinsonian rat brain. Kwan, C., Lévesque, C., Bédard, D., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A meta-analysis of the effectiveness and safety of safinamide for levodopa-induced motor complications in Parkinson's disease. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and tolerability of IRL790 in Parkinson's disease with levodopa-induced dyskinesia-a phase 1b trial. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Sarizotan as a treatment for dyskinesias in Parkinson's disease: a double-blind placebo-controlled trial. [2012]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of the D3 dopamine receptor selective antagonist PG01037 on L-dopa-dependent abnormal involuntary movements in rats. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of D2 and D3 dopamine receptor selective compounds on L-dopa-dependent abnormal involuntary movements in rats. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Randomized, placebo-controlled trial of ADS-5102 (amantadine) extended-release capsules for levodopa-induced dyskinesia in Parkinson's disease (EASE LID 3). [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Autoradiographic labelling of 5-HT3 receptors in the hemi-parkinsonian rat brain. [2022]

8. England pubmed.ncbi.nlm.nih.gov

In vivo characterization of a novel dopamine D3 receptor agonist to treat motor symptoms of Parkinson's disease. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

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. [2017]