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| Descriptive Information Fields | |
| Brief Title † | Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients |
| Official Title † | |
| Brief Summary | 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. |
| Detailed Description | |
| Study Phase | Phase III |
| Study Type † | Interventional |
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Primary Outcome Measure † | emotional control |
| Secondary Outcome Measure † | |
| Condition † | Multiple Sclerosis |
| Intervention † | Drug: AVP-923 |
| MEDLINE PMIDs | |
| Links | National Multiple Sclerosis Society ![]() |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 96 |
| Start Date † | December 2002 |
| Completion Date | December 2004 |
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 18 Years to 68 Years |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00050232 |
| Organization ID | 02-AVR-106 |
| Secondary IDs †† | |
| Study Sponsor † | Avanir Pharmaceuticals |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | Avanir Pharmaceuticals |
| Verification Date | June 2007 |
| First Received Date † | December 2, 2002 |
| Last Updated Date | December 26, 2007 |