ND0612 for Parkinson's Disease
(BouNDless Trial)

Recruiting in Palo Alto (17 mi)

+121 other locations

Overseen byOlivier Rascol, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: NeuroDerm Ltd.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a multi-center, randomized, double-blind, double-dummy, active controlled clinical Study. Following a screening period, eligible subjects will be enrolled to an open-label oral IR-LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR-LD/CD. Subjects can continue to an optional open-label extension period.

Eligibility Criteria

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.

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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.

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Treatment Details

Interventions

Carbidopa and Levodopa 25mg/100mg (Drug)
ND0612 Solution (Combination Product)
Placebo for Carbidopa and Levodopa 25mg/100mg (Drug)
Placebo for ND0612 Solution (Combination Product)

Trial OverviewThe 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.

Participant Groups

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.