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Efficacy Study of NH001 in Vegetative State & Minimally Conscious State Following a Traumatic Brain Injury (NH001-2)

This study has suspended participant recruitment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
NeuroHealing Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00761228
First received: September 26, 2008
Last updated: April 25, 2013
Last verified: April 2013

September 26, 2008
April 25, 2013
July 2010
December 2014   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00761228 on ClinicalTrials.gov Archive Site
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. [ Time Frame: Baseline, weekly during drug treatment and at follow up visits of days 90,180 and 360. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Brain Injury
  • 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.
  • Active Comparator: 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: Drug: Apomorphine
  • Placebo Comparator: Placebo
    Patients will receive a continues subcutaneous infusion of saline solution.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
76
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patient is between 18 and 50 years of age, inclusive.
  2. 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).
  3. Patients will have sustained a severe closed head injury within one to four months.
  4. Patients will have remained in a vegetative or minimally conscious state between one and four months after injury.
  5. Patients will have reached a stabilized clinical state prior to admission to the study (e.g. afebrile, haemodynamic and electrolyte stability).
  6. Patients will have a mean DRS score between 17 and 29, when measured twice a day over two consecutive days.
  7. Informed consent from a legal representative will have been obtained, according to the procedures outlined in Section 8.1.2.
  8. Patients who, according to the investigator's opinion, are likely to be available for the required 180-day follow up evaluation.

Exclusion Criteria:

  1. Patients who are not clinically stable at the time of entry into the study (infections, cardiovascular decompensation, etc.)
  2. Patients who require mechanical respiratory assistance.
  3. Patients who show signs of progressive neurological deterioration post-TBI.
  4. Patients with a known history of medically relevant substance abuse.
  5. Patients with history of cardiac disease.
  6. Patients who suffered an anoxic event.
  7. Patients who have received an investigational drug within 30 days of the study.
  8. 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.
  9. Patients who are receiving dopamine blockers (e.g. risperidone, haloperidol, chlorpromazine, flupenthixol, clozapine, olanzapine, quetiapine)
  10. Patients who are receiving drugs of the 5HT3 antagonist class, including, for example, ondansetron, granisetron, dolasetron, palonosetron and alosetron.
  11. Patients who are receiving tricyclic antidepressants drugs
  12. Patients who are receiving type I antiarrhythmics (i.e. quinidine).
  13. Patients who have a known history of cardiac arrhythmias or congenital QTc prolongation.
  14. Patients who have a known history of previous neurological functional impairment (e.g. stroke, spinal cord injury, dementia, epilepsy, psychiatric diseases).
  15. Patients who experienced seizures within the first week post injury or have ongoing seizures.
  16. Patients receiving prophylactic anti-convulsive medications.
  17. Patients with known allergies to apomorphine, morphine, sulfites or trimethobenzamide.
  18. Patients who are receiving nitrates or other vasodilators.
  19. Patients receiving CNS acting agents such as barbiturates, morphine, belladonna, opiates.
  20. For male patients, patients who are receiving trazodone or any other drug that is known to produce priapism.
  21. Patients without a relative or legal guardian to consent to the study.
  22. Patients who, according to the investigator's opinion, are unlikely to be available for the required 180-day follow up evaluation.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00761228
3337
Yes
NeuroHealing Pharmaceuticals Inc.
NeuroHealing Pharmaceuticals Inc.
FDA Office of Orphan Products Development
Principal Investigator: Elkan R Gamzu, PhD NeuroHealing Pharmaceuticals Inc.
Principal Investigator: Ross D Zafonte, DO Spaulding Rehabilitation Hospital
NeuroHealing Pharmaceuticals Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP