NCT01229332

A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients

A Phase I/II, Single-center, Randomized, Cross-over, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Administration of Subcutaneous Continuously-delivered Carbidopa Solution (ND0611) on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: NeuroDerm Ltd. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

A cross-over study, where ND0611 or placebo will be tested on top of 3 different LD/CD dosage forms. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa and the potential clinical effect of ND0611 will be explored in subjects with PD and motor fluctuations.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Saline	Continuous 24 h administration
DRUG	Carbidopa	Continuous 24 h administration

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-10-27
• Last updated: 2011-12-06

Locations

1 site across 1 country: Israel