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| Name | Class |
|---|---|
| FDA Office of Orphan Products Development | FED |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apomorphine | Active Comparator | Patients will receive an ascending dosing schedule to reach a maximum infusion rate of up to 6 mg/hour for 12 hours a day. |
|
| Placebo | Placebo Comparator | Patients will receive a continues subcutaneous infusion of saline solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apomorphine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence or absence of meaningful responses to external commands based on Coma Recovery Scale-Revised | Day 42 or the day that the drug treatment is discontinued, whichever happens earlier. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elkan R Gamzu, PhD | NeuroHealing Pharmaceuticals Inc. | Principal Investigator |
| Ross D Zafonte, DO | Spaulding Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D018458 | Persistent Vegetative State |
| D003128 | Coma |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D001058 | Apomorphine |
| ID | Term |
|---|---|
| D001060 | Aporphines |
| D044182 | Benzylisoquinolines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Patients will receive a continues subcutaneous infusion of saline solution. |
|
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001925 | Brain Damage, Chronic |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007546 |
| Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |