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

NeuroHealing Pharmaceuticals Inc.1 site in 1 country76 target enrollmentJuly 2010

ConditionsBrain Injury

InterventionsApomorphine Placebo

DrugsApomorphine Placebo

Overview

Phase: Phase 2
Intervention: Apomorphine
Conditions: Brain Injury
Sponsor: NeuroHealing Pharmaceuticals Inc.
Enrollment: 76
Locations: 1
Primary Endpoint: Presence or absence of meaningful responses to external commands based on Coma Recovery Scale-Revised
Status: Suspended
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

December 2018

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NeuroHealing Pharmaceuticals Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is between 18 and 50 years of age, inclusive.
•Male or non-pregnant female (females of child-bearing potential will be required to have undergone a pregnancy test with negative results prior to entry to the study).
•Patients will have sustained a severe closed head injury within one to four months.
•Patients will have remained in a vegetative or minimally conscious state between one and four months after injury.
•Patients will have reached a stabilized clinical state prior to admission to the study (e.g. afebrile, haemodynamic and electrolyte stability).
•Patients will have a mean DRS score between 17 and 29, when measured twice a day over two consecutive days.
•Informed consent from a legal representative will have been obtained, according to the procedures outlined in Section 8.1.
•Patients who, according to the investigator's opinion, are likely to be available for the required 180-day follow up evaluation.

Exclusion Criteria

•Patients who are not clinically stable at the time of entry into the study (infections, cardiovascular decompensation, etc.)
•Patients who require mechanical respiratory assistance.
•Patients who show signs of progressive neurological deterioration post-TBI.
•Patients with a known history of medically relevant substance abuse.
•Patients with history of cardiac disease.
•Patients who suffered an anoxic event.
•Patients who have received an investigational drug within 30 days of the study.
•Patients who have previously used NH001, other dopaminergic agent (e.g. levodopa, amantadine, domperidone) or any known neuro-stimulant (e.g. methylphenidate, amphetamines, atomoxetine, modafinil) within the last 7 days days.
•Patients who are receiving dopamine blockers (e.g. risperidone, haloperidol, chlorpromazine, flupenthixol, clozapine, olanzapine, quetiapine)
•Patients who are receiving drugs of the 5HT3 antagonist class, including, for example, ondansetron, granisetron, dolasetron, palonosetron and alosetron.

Arms & Interventions

Apomorphine

Patients will receive an ascending dosing schedule to reach a maximum infusion rate of up to 6 mg/hour for 12 hours a day.

Intervention: Apomorphine

Placebo

Patients will receive a continues subcutaneous infusion of saline solution.

Intervention: Placebo

Outcomes

Primary Outcomes

Presence or absence of meaningful responses to external commands based on Coma Recovery Scale-Revised

Time Frame: Day 42 or the day that the drug treatment is discontinued, whichever happens earlier.

Secondary Outcomes

Coma/Near Coma Scale (CNC) Disability Rating Scale (DRS), Glasgow Outcome Scale Extended (GOS-E), ability to participate in 3 hours a day of active rehabilitation, and a clinical impression of change.(Baseline, weekly during drug treatment and at follow up visits of days 90,180 and 360.)