Efficacy Study of NH001 in Vegetative State & Minimally Conscious State Following a Traumatic Brain Injury
Information source: FDA Office of Orphan Products Development
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain Injury
Intervention: Apomorphine (Drug); Placebo (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: FDA Office of Orphan Products Development Official(s) and/or principal investigator(s):
Elkan R Gamzu, PhD, Principal Investigator, Affiliation: NeuroHealing Pharmaceuticals Inc.
Ross D Zafonte, DO, Principal Investigator, Affiliation: Spaulding Rehabilitation Hospital
Overall contact:
Daniel Katzman, Phone: 617.331.4111, Email: daniel@neurohealing.com
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Presence or absence of meaningful responses to external commands based on Coma Recovery Scale-Revised
Secondary outcome: 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.
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 TBI.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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 or any known
neurostimulant (methylphenidate, amphetamines, atomoxetine, modafinil) within the
last 7 days.
9. Patients who are receiving dopamine blockers (haloperidol, valproate)
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 trazadone 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.
Locations and Contacts
Daniel Katzman, Phone: 617.331.4111, Email: daniel@neurohealing.com
Spaulding Rehabilitation Hospital, Boston, Massachusetts 02114, United States
Additional Information
Starting date: November 2008
Ending date: October 2010
Last updated: September 26, 2008
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