Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients
This study has been completed.
Sponsor:
Avanir Pharmaceuticals
Information provided by:
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00050232
First received: December 2, 2002
Last updated: August 4, 2009
Last verified: August 2009
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
Drug Information available for:
Nuedexta
U.S. FDA Resources
Further study details as provided by Avanir Pharmaceuticals:
Eligibility| Ages Eligible for Study: | 18 Years to 68 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 to 68 years of age
- Confirmed diagnosis of Multiple Sclerosis
- Clinical history of pseudobulbar affect
Exclusion Criteria:
- Sensitivity to quinidine or opiate drugs
- Recent diagnosed within 2 months with Multiple Sclerosis
- Patient on anti-depressants
- Patient with liver or kidney disease
- Patient with hypotension
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050232
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 | |
| Radiant Research Alexian Brothers | |
| Elk Grove Village, Illinois, United States, 60007 | |
| 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 | |
| Upstate Clinical Research | |
| Albany, New York, United States, 12205 | |
| DENT Neurologic Group L.L.P. | |
| Amherst, New York, United States, 14266 | |
| Hospital for Joint Diseases - MS Care Center | |
| New York, New York, United States, 10003 | |
| Institute for Human Performance | |
| Syracuse, New York, United States, 13210 | |
| 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 | |
| Westmorland Neurology | |
| Greensburg, Pennsylvania, United States, 15601 | |
| Neurological Associates of Delaware Valley | |
| Upland, Pennsylvania, United States, 19013 | |
| 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 | |
Sponsors and Collaborators
Avanir Pharmaceuticals
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00050232 History of Changes |
| Other Study ID Numbers: | 02-AVR-106 |
| Study First Received: | December 2, 2002 |
| Last Updated: | August 4, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Avanir Pharmaceuticals:
|
Pseudobulbar Affect Uncontrolled Laughing Crying |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013