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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to the end of dbdd maintenance period (12 weeks)
Awards & highlights

BouNDless 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.Check my eligibility
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.See study design
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.

BouNDless Trial 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.

BouNDless Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The change in daily ON time without troublesome dyskinesia
Secondary outcome measures
The change in daily OFF time

BouNDless 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.

Find a Location

Who is running the clinical trial?

NeuroDerm Ltd.Lead Sponsor
13 Previous Clinical Trials
456 Total Patients Enrolled
Alberto J Espay, MD, MScPrincipal InvestigatorUniversity of Cincinnati OH, USA
Olivier Rascol, MD, PhDPrincipal InvestigatorToulouse University Hospital, France

Media Library

ND0612 Solution (Combination Product) Clinical Trial Eligibility Overview. Trial Name: NCT04006210 — Phase 3
Parkinson's Disease Research Study Groups: Open-Label Extension, IR-LD/CD Group, Oral IR-LD/CD Adjustment, ND0612 Conversion, ND0612 Group
Parkinson's Disease Clinical Trial 2023: ND0612 Solution Highlights & Side Effects. Trial Name: NCT04006210 — Phase 3
ND0612 Solution (Combination Product) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04006210 — Phase 3
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT04006210 — Phase 3
~67 spots leftby Jun 2025
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