NCT00761228

Efficacy Study of NH001 in Vegetative State & Minimally Conscious State Following a Traumatic Brain Injury

A Double-blind, Placebo-controlled, Randomized Study of the Safety and Efficacy of NH001 in Improving the Functional Outcome of Patients in a Vegetative State or Minimally Conscious State Following a Severe Traumatic Brain Injury

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: NeuroHealing Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the drug apomorphine in subjects who are in a Vegetative State or a Minimally Conscious State.

Detailed description

This is a prospective, multi-center, randomized, double-blind, placebo-controlled study of the safety and efficacy of NH001 to improve the functional outcome of patients in a vegetative state or minimally conscious state following a severe traumatic brain injury (TBI).

Conditions

• Brain Injury

Interventions

Type	Name	Description
DRUG	Apomorphine	Patients will receive an ascending dosing schedule of continuous subcutaneous apomorphine to reach a maximum infusion rate of up to 6 mg/hour for 12 hours a day.
DRUG	Placebo	Patients will receive a continues subcutaneous infusion of saline solution.

Timeline

• Start date: 2010-07-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2008-09-29
• Last updated: 2017-03-31

Locations

1 site across 1 country: United States