MedTrace Logo

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

NCT00761228 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2017-03-31

No results posted yet for this study

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.

Conditions

  • Brain Injury

Interventions

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.

Sponsors & Collaborators

  • FDA Office of Orphan Products Development

    collaborator FED

  • NeuroHealing Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Elkan R Gamzu, PhD · NeuroHealing Pharmaceuticals Inc.

  • Ross D Zafonte, DO · Spaulding Rehabilitation Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00761228 on ClinicalTrials.gov