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| Sponsor: | Avanir Pharmaceuticals |
|---|---|
| Information provided by: | Avanir Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00056524 |
Purpose
The purpose of this study is to evaluate the long-term safety of AVP-923 in the treatment of Involuntary Emotional Expression Disorder (IEED) also known as Pseudobulbar Affect (episodes of uncontrolled crying and/or laughter).
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease Stroke Parkinson's Disease Traumatic Brain Injury |
Drug: AVP-923 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect. |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Barrow Neurological Institute | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| UCLA School of Medicine | |
| Los Angeles, California, United States, 90095 | |
| UCSF | |
| San Francisco, California, United States, 94117 | |
| Center for Neurologic Study | |
| La Jolla, California, United States, 92037 | |
| United States, Connecticut | |
| Research Center for Clinical Studies, Inc. | |
| Darien, Connecticut, United States, 06820 | |
| United States, District of Columbia | |
| George Washington University Medical Faculty Assoc. | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Neurological Associates | |
| Ft. Lauderdale, Florida, United States, 33334 | |
| University of Miami Dept. of Neurology | |
| Miami, Florida, United States, 33136 | |
| Renstar Medical Research | |
| Plantation, Florida, United States, 33324 | |
| Suncoast Neuroscience Associates Inc. | |
| St. Petersburg, Florida, United States, 33701 | |
| Tampa, Florida, United States, 33606 | |
| Allied Clinical Trials | |
| Miami, Florida, United States, 33181 | |
| Miami Jewish Home & Hospital for the Aged | |
| Miami, Florida, United States, 33137 | |
| United States, Georgia | |
| Neurology & Headache Specialist of Atlanta, L.L.C. | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| Consultants in Neurology LTD | |
| Northbrook, Illinois, United States, 60062 | |
| United States, Montana | |
| Advanced Neurology Specialists | |
| Great Falls, Montana, United States, 59405 | |
| United States, Nebraska | |
| Neurological Associates, P.C. | |
| Lincoln, Nebraska, United States, 68506 | |
| United States, New York | |
| Hospital for Joint Diseases MS Care Center | |
| New York, New York, United States, 10003 | |
| SUNY Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| Upstate Clinical Research | |
| Albany, New York, United States, 12205 | |
| DENT Neurologic Group L.L.P. | |
| Amherst, New York, United States, 14266 | |
| United States, North Carolina | |
| Raleigh Neurology Associates, PA | |
| Raleigh, North Carolina, United States, 27607 | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, Ohio | |
| NeuroCare Center, Inc. | |
| Canton, Ohio, United States, 44718 | |
| MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| University Memory and Aging Center | |
| Cleveland, Ohio, United States, 44120 | |
| The Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oklahoma | |
| Clinical Pharmaceutical Trials, Inc. | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Pennsylvania | |
| Lehigh Valley Neurosciences and Pain Research Center | |
| Allentown, Pennsylvania, United States, 18103 | |
| Neurological Associates of Delaware Valley | |
| Upland, Pennsylvania, United States, 19013 | |
| Penn Neurological Institute | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Westmoreland Neurology | |
| Greensburg, Pennsylvania, United States, 15601 | |
| MCP-Hahnemann University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Jenkintown, Pennsylvania, United States, 19046 | |
| United States, Texas | |
| Methodist Neurological Institute | |
| Houston, Texas, United States, 77030 | |
| Claghorn-Lesem Research Clinic | |
| Bellaire, Texas, United States, 77401 | |
| United States, Vermont | |
| Fletcher Allen Health Care | |
| Burlington, Vermont, United States, 05401 | |
| United States, Washington | |
| Neurology and Neurosurgery Associates of Tacoma | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
More Information
| Study ID Numbers: | 02-AVR-107, AVP-923 |
| Study First Received: | March 15, 2003 |
| Last Updated: | August 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00056524 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
ALS MS CNS AD |
TBI Dextromethorphan IEED Emotional |
|
Craniocerebral Trauma Alzheimer Disease Nervous System Diseases Basal Ganglia Diseases Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System Brain Diseases |
Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Movement Disorders Parkinson Disease Mental Disorders Parkinsonian Disorders Brain Injuries Dementia Tauopathies |
