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
| Tracking Information | |
|---|---|
| First Received Date ICMJE | December 2, 2002 |
| Last Updated Date | August 4, 2009 |
| Start Date ICMJE | December 2002 |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE |
emotional control |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00050232 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients |
| Official Title ICMJE | Not Provided |
| 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 | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 3 |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Condition ICMJE | Multiple Sclerosis |
| Intervention ICMJE | Drug: AVP-923 |
| Study Arm (s) | Not Provided |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 96 |
| Completion Date | December 2004 |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 18 Years to 68 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00050232 |
| Other Study ID Numbers ICMJE | 02-AVR-106 |
| Has Data Monitoring Committee | No |
| Responsible Party | Not Provided |
| Study Sponsor ICMJE | Avanir Pharmaceuticals |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Avanir Pharmaceuticals |
| Verification Date | August 2009 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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