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| Sponsored by: |
Avanir Pharmaceuticals |
|---|---|
| Information provided by: | Avanir Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00050232 |
Purpose
Pseudobulbar Affect is a condition characterized by frequent episodes of laughing and crying out of proportion. Other terms used to describe this condition include emotional lability, emotionalism, emotion incontinence, emotional discontrol, excessive emotionalism and pathological laughing and crying. AVP-923 is a new experimental drug that may assist in the reduction of uncontrolled episodes. This study will test the safety and efficacy of AVP-923 in the treatment of MS patients suffering from pseudobulbar affect.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: AVP-923 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Eligibility| Ages Eligible for Study: | 18 Years to 68 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Barrow Neurological Institute | |
| Phoenix, Arizona, United States, 85013 | |
| United States, District of Columbia | |
| George Washington University Medical Faculty Associates | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Neurological Associates | |
| Ft. Lauderdale, Florida, United States, 33334 | |
| 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 | |
| Radiant Research Alexian Brothers | |
| Elk Grove Village, Illinois, United States, 60007 | |
| 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 | |
| Upstate Clinical Research | |
| Albany, New York, United States, 12205 | |
| Institute for Human Performance | |
| Syracuse, New York, United States, 13210 | |
| DENT Neurologic Group L.L.P. | |
| Amherst, New York, United States, 14266 | |
| United States, North Carolina | |
| Raleigh Neurology Associates, P.A. | |
| Raleigh, North Carolina, United States, 27607 | |
| United States, Ohio | |
| NeuroCare Center, Inc. | |
| Canton, Ohio, United States, 44718 | |
| United States, Pennsylvania | |
| Leheigh Valley Neurosciences and Pain Research Center | |
| Allentown, Pennsylvania, United States, 18103 | |
| Neurological Associates of Delaware Valley | |
| Upland, Pennsylvania, United States, 19013 | |
| Westmorland Neurology | |
| Greensburg, Pennsylvania, United States, 15601 | |
| United States, Vermont | |
| FACH-UHC Department of Neurological Services | |
| Burlington, Vermont, United States, 05401 | |
| United States, Washington | |
| Swedish Medical Center | |
| Seattle, Washington, United States, 98122 | |
| Neurology and Neurosurgery Associates of Tacoma | |
| Tacoma, Washington, United States, 98405 | |
More Information
| Study ID Numbers: | 02-AVR-106 |
| Study First Received: | December 2, 2002 |
| Last Updated: | December 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00050232 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Pseudobulbar Affect Uncontrolled Laughing Crying |
|
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases |
Demyelinating Autoimmune Diseases, CNS Sclerosis Autoimmune Diseases of the Nervous System |
|
Pathologic Processes Autoimmune Diseases Multiple Sclerosis Immune System Diseases Demyelinating Diseases |
Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Sclerosis Autoimmune Diseases of the Nervous System |