ND0612 for Parkinson's Disease

(BouNDless Trial)

Not currently recruiting at 132 trial locations

Overseen By Eran Tavor

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: NeuroDerm Ltd.

Must be taking: Levodopa

Must not be taking: Apomorphine, Inhaled levodopa

Disqualifiers: Atypical parkinsonism, Severe dyskinesias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ND0612, a continuous subcutaneous infusion, for people with Parkinson's disease who experience significant daily "OFF" time (periods when medication isn't working well). The researchers will compare ND0612 to a placebo, alongside existing oral medications, to determine if it can better manage Parkinson's symptoms. This trial may suit those diagnosed with Parkinson's disease who have at least 2 hours of "OFF" time daily and take multiple doses of levodopa each day. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment option.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot use certain medications like subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks before starting. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ND0612 is generally safe for people with Parkinson's disease. ND0612 is a continuous infusion of medication administered just under the skin to help manage movement problems in Parkinson's. Studies have found it doesn't cause major safety issues. In one study, participants used it for a year and improved their mobility by more than 2 hours each day. This suggests ND0612 is likely safe for most people. However, like any treatment, side effects can occur, so it's important to talk to a doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for Parkinson's Disease?

Researchers are excited about ND0612 for Parkinson's disease because it offers a novel continuous subcutaneous infusion method. Unlike the standard oral levodopa/carbidopa treatments, which often lead to fluctuating dopamine levels and unpredictable symptom control, ND0612 provides a steady delivery of medication. This continuous infusion helps maintain more consistent dopamine levels and potentially reduces motor complications. By offering a more stable therapeutic effect, ND0612 aims to improve the quality of life for those with Parkinson's disease.

What evidence suggests that this trial's treatments could be effective for Parkinson's Disease?

Research has shown that ND0612, which participants in this trial may receive, might help with movement problems in people with Parkinson's disease. In earlier studies, ND0612 improved movement by more than 2 hours. This treatment delivers medication steadily under the skin, controlling symptoms more effectively than pills. Patients found it safe and easy to use over time. These results suggest that ND0612 could be a good option for those struggling with regular Parkinson's treatments. ^{2 3 4 6 7}

Who Is on the Research Team?

Olivier Rascol, MD, PhD

Principal Investigator

Toulouse University Hospital, France

Alberto Espay, MD

Principal Investigator

University of Cincinnati OH, USA

Are You a Good Fit for This Trial?

This trial is for adults aged 30 or older with Parkinson's Disease who experience at least 2 hours of 'OFF' time daily, despite taking levodopa. They should not have had neurosurgery for PD, severe skin conditions, disabling dyskinesias, or used certain PD medications recently.

Inclusion Criteria

You have been diagnosed with Parkinson's disease according to the United Kingdom Brain Bank Criteria.

I experience more than 2.5 hours of symptom worsening during the day.

I take 4 or more daily doses of levodopa, totaling 400mg or more.

Exclusion Criteria

My condition is not typical Parkinson's but a variant or caused by another condition.

I haven't used apomorphine injections, sublingual apomorphine, or inhaled levodopa in the last 4 weeks.

I am using a duodenal levodopa or apomorphine infusion.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Oral IR-LD/CD Adjustment

Participants undergo an open-label oral IR-LD/CD adjustment period

4-6 weeks

ND0612 Conversion

Participants undergo an open-label ND0612 conversion period

4-6 weeks

Maintenance

Randomized double-blind, double-dummy active-controlled maintenance period

12 weeks

Open-label Extension (optional)

Participants may opt into continuation of treatment long-term

up to 54 months

Safety Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Carbidopa and Levodopa 25mg/100mg
• ND0612 Solution
• Placebo for Carbidopa and Levodopa 25mg/100mg
• Placebo for ND0612 Solution

Trial Overview The study compares ND0612, a continuous subcutaneous infusion solution, to the standard oral immediate-release Levodopa/Carbidopa (IR-LD/CD). Participants will first adjust to IR-LD/CD before switching to ND0612 or placebo and then may enter an open-label extension.

How Is the Trial Designed?

Group I: Oral IR-LD/CD Adjustment Experimental Treatment 1 Intervention

Active IR-LD/CD (white capsules). Open-label Treatment in Run-in 1 for 4-6 weeks.

Group II: Open-Label Extension Experimental Treatment 1 Intervention

ND0612 continuous SC infusion + Standard of care LD/dopa-decarboxylase inhibitor. Open-label Treatment in Extension for up to 54 months.

Group III: ND0612 Group Experimental Treatment 3 Interventions

ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules) + Placebo IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.

Group IV: ND0612 Conversion Experimental Treatment 2 Interventions

ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules). Open-label Treatment in Run-in 2 for 4-6 weeks.

Group V: IR-LD/CD Group Active Control 3 Interventions

Placebo for ND0612 continuous SC infusion + Placebo IR-LD/CD (grey capsules) + Active IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.

Who Is Running the Clinical Trial?

NeuroDerm Ltd.

Lead Sponsor

Trials

14

Recruited

840+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39884033/

3-year outcomes from the open-label BeyoND study One-year data from the ongoing BeyoND study (NCT02726386) showed that the ND0612 regimen was safe and well tolerated and provided a sustained ≥2-h improvement ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04006210

Efficacy, Safety and Tolerability Study of ND0612 vs. Oral ... Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/​Carbidopa (IR-LD/​CD) in Subjects With Parkinson's Disease Experiencing ...

3. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(24)00052-8/abstract

Safety and efficacy of continuous subcutaneous levodopa ... ND0612 might offer a safe and efficacious subcutaneous levodopa infusion approach to managing motor fluctuations in people with Parkinson's ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1353802025000343

Long-term, continuous, subcutaneous levodopa/carbidopa ... One-year data from the ongoing BeyoND study (NCT02726386) showed that the ND0612 regimen was safe and well tolerated and provided a sustained ≥2-h improvement ...

5. mt-pharma-america.com mt-pharma-america.com/media/press-releases/2024/mitsubishi-tanabe-pharma-america-presents-open-label-extension-outcomes-and-additional-data-from-phase-3-boundless-trial-of-investigational-nd0612-in-parkinsons-disease

Individual Press Releases - Mitsubishi Tanabe Pharma ... One-year outcomes from open-label extension to BouNDless study reaffirm previously published data regarding long-term efficacy of ND0612.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38499015/

Safety and efficacy of continuous subcutaneous levodopa ... ND0612 might offer a safe and efficacious subcutaneous levodopa infusion approach to managing motor fluctuations in people with Parkinson's ...

7. neuroderm.com neuroderm.com/our-solution/about/what-is-nd0612/

What is ND0612? - Neuroderm ND0612 is a novel solution designed to overcome the main shortcomings of the established oral levodopa/carbidopa treatment.