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Combination Product

ND0612 for Parkinson's Disease (BouNDless Trial)

Phase 3

Waitlist Available

Led By Alberto J Espay, MD, MSc

Research Sponsored by NeuroDerm Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Average of ≥2.5 hours of OFF time (≥2 hours OFF every day) during waking hours as conﬁrmed by patient diary over 3 days.

Taking 4 or more levodopa doses/day (3 or more doses/day of extended release LD/dopa-decarboxylase inhibitor, e.g., Rytary®) at a total daily dose of 400mg or more

Must not have

Atypical or secondary parkinsonism

Use of duodenal levodopa infusion (LCIG) or apomorphine infusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to the end of dbdd maintenance period (12 weeks)

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new drug to see if it's effective and safe. Subjects will take the drug for a year and then be evaluated.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include those typical of Levodopa treatments such as nausea, dizziness upon standing (orthostatic hypotension), involuntary movements (dyskinesia), and sleepiness. The infusion could cause local reactions like redness or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am 30 years old or older.

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My Parkinson's symptoms are mild to moderate when my medication is working.

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I experience at least 2 hours of 'OFF' time daily.

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I am 30 years old or older.

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My Parkinson's disease allows me to walk and stand unassisted.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am using a duodenal levodopa or apomorphine infusion.

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I have a history of serious skin conditions.

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I have had brain surgery for Parkinson's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to the end of dbdd maintenance period (12 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to the end of dbdd maintenance period (12 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to the end of dbdd maintenance period (12 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The change in daily ON time without troublesome dyskinesia

Secondary study objectives

The change in daily OFF time

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Oral IR-LD/CD AdjustmentExperimental Treatment1 Intervention

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

Group II: Open-Label ExtensionExperimental Treatment1 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 GroupExperimental Treatment3 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 ConversionExperimental Treatment2 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 GroupActive Control3 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.

0 / 12Eligibility criteria met