NCT02782481

A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations

A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NeuroDerm Ltd. · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double blind, placebo controlled parallel group clinical study. Following a screening period of up to 28 days, eligible subjects will be randomized to receive adjunct treatment to oral LD/DDI (Dopa Decarboxylase Inhibitor) with continuous subcutaneous infusion of ND0612 or matching placebo for 16 weeks.

Detailed description

This phase III randomized, double-blind, placebo controlled, parallel group clinical study will be conducted in 150 subjects with idiopathic PD who are experiencing motor complications despite optimized anti-PD therapy. The study will investigate the efficacy, safety and tolerability of continuous SC infusion (16 weeks) of ND0612 compared with placebo infusion. The treatment period will be comprised of a 4-week adjustment period during which time the ND0612 infusion dose will remain constant and the oral LD/DDI dose can be decreased or increased back up to the Baseline levels. All other anti-PD treatments must remain constant. During the maintenance period (Weeks 5 to 16) all anti-PD medication including the ND0612/placebo should remain constant.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	ND0612
DRUG	Placebo

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-10-15
• Completion: 2018-10-15
• First posted: 2016-05-25
• Last updated: 2019-12-10

Locations

1 site across 1 country: Israel