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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.
Select...
I experience at least 2 hours of 'OFF' time daily.
Select...
I am 30 years old or older.
Select...
My Parkinson's disease allows me to walk and stand unassisted.
Select...
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: IR-LD/CD Group, Oral IR-LD/CD Adjustment, ND0612 Conversion, ND0612 Group, Open-Label Extension
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please list other times when ND0612 Solution has been used in a clinical trial?

"177 studies have completed investigating the effects of ND0612 Solution for SC infusion, which was originally studied in 2014 at Tel Aviv Sourasky Medical Center. Of the 17 ongoing studies, a significant proportion are taking place within Boston, Massachusetts."

Answered by AI

Can you tell me how many hospitals are participating in this research project?

"There are a total of 44 hospitals and medical centres currently running this study. In the Northeastern region of the United States, there are locations such as Beth Israel Deaconess Medical Center in Boston and Weill Cornell Medicine in New york. Alternatively, for those on the West Coast, Hawaii Pacific Neuroscience in Honolulu is an option."

Answered by AI

Has the Food and Drug Administration cleared ND0612 Solution for SC infusion?

"There is some evidence from previous trials to suggest that ND0612 Solution for SC infusion is effective, and it has been through multiple rounds of testing to ensure safety. Therefore, we have given it a score of 3."

Answered by AI

What are the main indications for using ND0612 Solution for SC infusion?

"ND0612 Solution for SC infusion can be used to treat manganese intoxication and other conditions like advanced motor fluctuations, restless legs syndrome (rls), and carbon monoxide intoxication."

Answered by AI

Are we still enrolling volunteers for this experiment?

"This study is not recruiting patients at the moment. According to the posting dates (August 27th, 2019 and May 17th, 2022), as well as the last edit date, it seems as if this trial is inactive. There are currently 517 trials searching for patients with Parkinson's disease and 17 trials for ND0612 Solution for SC infusion."

Answered by AI

How many people are taking part in this experiment?

"This specific trial is not actively recruiting patients right now, however, there are 517 other clinical trials for parkinson disease and 17 studies enrolling patients for ND0612 Solution for SC infusion."

Answered by AI

What are the requirements to participate in this research project?

"381 patients that fit the age demographic of 30-80 and have been diagnosed with parkinson disease are eligible for this trial. There are also certain requirements that applicants must meet, such as being male or female, having an Hoehn & Yahr score of 3 or lower during times when the medication is active, and having at least 2.5 hours of OFF time per day (as confirmed by a patient diary over the course of 3 days)."

Answered by AI

Do the requirements for participating in this trial include an age limit?

"According to the specific guidelines for this trial, applicants between the ages of 30 and 80 may be eligible. There are 28 trials involving patients under 18 and 529 trials with senior citizens above 65."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Florida
Other
California
How old are they?
18 - 65
65+
What site did they apply to?
Collaborative Neuroscience Network
Cedar- Sinai Medical Center Department of Neurology
University of California San Francisco
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
2

Why did patients apply to this trial?

Dystonia and some dyskinesia from sinemet. If this trial is for a replacement, I'd like to do it.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
~70 spots leftby Mar 2025