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 — BouNDless  

Parkinson's Disease Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

• NCT number: NCT04006210
• Study type: Interventional
• Source: NeuroDerm Ltd.
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 30, 2019
• Completion date: February 2027