Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050232
• Other study ID #: 02-AVR-106
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2002
• Last updated: July 13, 2016
• Start date: December 2002
• Est. completion date: June 2004

Study information

• Verified date: July 2016
• Source: Avanir Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 68 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• AVP-923

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Avanir Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	emotional control

External Links

•   National Multiple Sclerosis Society