Clinical trial NCT00050232: Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: Pseudobulbar Affect
Uncontrolled
Laughing
Crying
Lead sponsor: Avanir Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2002-12-03
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: emotional control
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
city: Ft. Lauderdale
country: United States
facility: Neurological Associates
state: Florida
city: Decatur
country: United States
facility: Neurology & Headache Specialist of Atlanta, L.L.C.
state: Georgia
city: Elk Grove Village
country: United States
facility: Radiant Research Alexian Brothers
state: Illinois
city: Northbrook
country: United States
facility: Consultants in Neurology LTD
state: Illinois
city: Great Falls
country: United States
facility: Advanced Neurology Specialists
state: Montana
city: Lincoln
country: United States
facility: Neurological Associates, P.C.
state: Nebraska
city: Albany
country: United States
facility: Upstate Clinical Research
state: New York
city: Amherst
country: United States
facility: DENT Neurologic Group L.L.P.
state: New York
city: New York
country: United States
facility: Hospital for Joint Diseases - MS Care Center
state: New York
city: Syracuse
country: United States
facility: Institute for Human Performance
state: New York
city: Raleigh
country: United States
facility: Raleigh Neurology Associates, P.A.
state: North Carolina
city: Canton
country: United States
facility: NeuroCare Center, Inc.
state: Ohio
city: Allentown
country: United States
facility: Leheigh Valley Neurosciences and Pain Research Center
state: Pennsylvania
city: Greensburg
country: United States
facility: Westmorland Neurology
state: Pennsylvania
city: Upland
country: United States
facility: Neurological Associates of Delaware Valley
state: Pennsylvania
city: Burlington
country: United States
facility: FACH-UHC Department of Neurological Services
state: Vermont
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Tacoma
country: United States
facility: Neurology and Neurosurgery Associates of Tacoma
state: Washington
Study officials:
References:
citation: 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.