ND0612 for Parkinson's Disease

(BouNDless Trial)

Recruiting at 121 trial locations

Overseen By Eran Tavor

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: NeuroDerm Ltd.

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

381 Participants Needed

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.

Research Team

Olivier Rascol, MD, PhD

Principal Investigator

Toulouse University Hospital, France

Alberto Espay, MD

Principal Investigator

University of Cincinnati OH, USA

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.

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

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

Treatment Details

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.

Participant Groups

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+