NCT04006210

Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations

A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel-group Clinical Trial, Investigating the Efficacy, Safety, and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: NeuroDerm Ltd. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a phase III multi-center, randomized, active-controlled, double-blind, double-dummy (DBDD), parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous (SC) ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson's disease (PD) experiencing motor fluctuations. This study is comprised of 6 periods: 1. a Screening Period; 2. an open-label oral IR-LD/CD Adjustment Period; 3. an open-label ND0612 Conversion Period; 4. a randomized DBDD active-controlled Maintenance Period; 5. an optional open-label Treatment Extension; and 6. a Safety Follow-up Period.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
COMBINATION_PRODUCT	ND0612 Solution for SC infusion	Levodopa/Carbidopa (LD/CD) solution administered SC via infusion pump
COMBINATION_PRODUCT	Placebo for SC infusion	Placebo solution administered SC via infusion pump
DRUG	Oral IR-LD/CD	Encapsulated LD/CD 100mg/25mg
DRUG	Placebo for Oral IR-LD/CD	Encapsulated Placebo for LD/CD 100mg/25mg

Timeline

• Start date: 2019-09-30
• Primary completion: 2022-11-01
• Completion: 2027-02-01
• First posted: 2019-07-05
• Last updated: 2025-05-21

Locations

103 sites across 16 countries: United States, Austria, Belgium, Czechia, France, Hungary, Israel, Italy, Netherlands, Poland, Portugal, Russia, Slovakia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study