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

Completed · Phase 3

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT00050232

Run by

Avanir Pharmaceuticals

People needed

96

Starts

2002-12-01

Expected to finish

2004-06-01

Last updated by the study team

2016-07-14

Who can join

Age: 18 and older, up to 68. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 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

Where it is running

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

Full record on ClinicalTrials.gov

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