Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients
1 other identifier
interventional
96
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 multiple-sclerosis
Started Dec 2002
Shorter than P25 for phase_3 multiple-sclerosis
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
December 2, 2002
CompletedFirst Posted
Study publicly available on registry
December 3, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedJuly 14, 2016
July 1, 2016
1.5 years
December 2, 2002
July 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
emotional control
Interventions
Eligibility Criteria
You may qualify if:
- to 68 years of age
- Confirmed diagnosis of Multiple Sclerosis
- Clinical history of pseudobulbar affect
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Neurological Associates
Fort Lauderdale, Florida, 33334, United States
Neurology & Headache Specialist of Atlanta, L.L.C.
Decatur, Georgia, 30033, United States
Radiant Research Alexian Brothers
Elk Grove Village, Illinois, 60007, United States
Consultants in Neurology LTD
Northbrook, Illinois, 60062, United States
Advanced Neurology Specialists
Great Falls, Montana, 59405, United States
Neurological Associates, P.C.
Lincoln, Nebraska, 68506, United States
Upstate Clinical Research
Albany, New York, 12205, United States
DENT Neurologic Group L.L.P.
Amherst, New York, 14266, United States
Hospital for Joint Diseases - MS Care Center
New York, New York, 10003, United States
Institute for Human Performance
Syracuse, New York, 13210, United States
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, 27607, United States
NeuroCare Center, Inc.
Canton, Ohio, 44718, United States
Leheigh Valley Neurosciences and Pain Research Center
Allentown, Pennsylvania, 18103, United States
Westmorland Neurology
Greensburg, Pennsylvania, 15601, United States
Neurological Associates of Delaware Valley
Upland, Pennsylvania, 19013, United States
FACH-UHC Department of Neurological Services
Burlington, Vermont, 05401, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Neurology and Neurosurgery Associates of Tacoma
Tacoma, Washington, 98405, United States
Related Publications (1)
Panitch HS, Thisted RA, Smith RA, Wynn DR, Wymer JP, Achiron A, Vollmer TL, Mandler RN, Dietrich DW, Fletcher M, Pope LE, Berg JE, Miller A; Psuedobulbar Affect in Multiple Sclerosis Study Group. Randomized, controlled trial of dextromethorphan/quinidine for pseudobulbar affect in multiple sclerosis. Ann Neurol. 2006 May;59(5):780-7. doi: 10.1002/ana.20828.
PMID: 16634036RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 2, 2002
First Posted
December 3, 2002
Study Start
December 1, 2002
Primary Completion
June 1, 2004
Study Completion
June 1, 2004
Last Updated
July 14, 2016
Record last verified: 2016-07