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| Sponsor: | NeuroHealing Pharmaceuticals Inc. |
|---|---|
| Collaborator: |
FDA Office of Orphan Products Development |
| Information provided by: | FDA Office of Orphan Products Development |
| ClinicalTrials.gov Identifier: | NCT00761228 |
Purpose
The purpose of this study is to test the drug apomorphine in subjects who are in a Vegetative State or a Minimally Conscious State.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Injury |
Drug: Apomorphine Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 76 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
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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.
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Placebo Comparator: Placebo
Patients will receive a continues subcutaneous infusion of saline solution.
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Drug: Placebo
Patients will receive a continues subcutaneous infusion of saline solution.
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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| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Daniel Katzman | 617.331.4111 | daniel@neurohealing.com |
| United States, Massachusetts | |
| Spaulding Rehabilitation Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Ross D Zafonte, DO 617-573-7000 rzafonte@partners.org | |
| Contact: Heechin Chae, MD 617-573-2770 hchae@partners.org | |
| Principal Investigator: Ross D Zafonte, DO | |
| Sub-Investigator: Heechin Chae, MD | |
| Principal Investigator: | Elkan R Gamzu, PhD | NeuroHealing Pharmaceuticals Inc. |
| Principal Investigator: | Ross D Zafonte, DO | Spaulding Rehabilitation Hospital |
More Information
| Responsible Party: | Elkan Gamzu, Interim Head of Clinical Trials, NeuroHealing Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00761228 History of Changes |
| Other Study ID Numbers: | 3337 |
| Study First Received: | September 26, 2008 |
| Last Updated: | July 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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Vegetative State Minimally Conscious State Coma Traumatic Brain Injury |
Unconsciousness Vegetative State secondary to a Traumatic Brain Injury Minimally Conscious State secondary to a Traumatic Brain Injury |
|
Brain Injuries Persistent Vegetative State Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Brain Damage, Chronic Unconsciousness Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations |
Signs and Symptoms Apomorphine Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |