Safety Study of AVP-923 in the Treatment of IEED (Involuntary Emotional Expression Disorder) Also Known as Pseudobulbar Affect (Episodes of Uncontrolled Crying and/or Laughter)

Completed · Phase 3

Conditions studied: Alzheimer's Disease, Stroke, Parkinson's Disease, Traumatic Brain Injury

In brief

The purpose of this study is to evaluate the long-term safety of AVP-923 in the treatment of Involuntary Emotional Expression Disorder (IEED) also known as Pseudobulbar Affect (episodes of uncontrolled crying and/or laughter).

Key facts

Study ID

NCT00056524

Run by

Avanir Pharmaceuticals

People needed

600

Starts

2003-02-01

Expected to finish

2007-06-01

Last updated by the study team

2016-07-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 to 75 years of age, inclusive
• Clinical diagnosis of PBA (pseudobulbar affect)
• If female, must not be pregnant or breast feeding

You may not qualify if…

• Sensitivity to quinidine or any opiate drugs
• Current or prior history of major psychiatric disturbance
• Currently participated in a trial within the past 30 days

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• Center for Neurologic Study — La Jolla, California, United States
• UCLA School of Medicine — Los Angeles, California, United States
• UCSF — San Francisco, California, United States
• Research Center for Clinical Studies, Inc. — Darien, Connecticut, United States
• George Washington University Medical Faculty Assoc. — Washington D.C., District of Columbia, United States
• Neurological Associates — Fort Lauderdale, Florida, United States
• University of Miami Dept. of Neurology — Miami, Florida, United States
• Miami Jewish Home & Hospital for the Aged — Miami, Florida, United States
• Allied Clinical Trials — Miami, Florida, United States
• Renstar Medical Research — Plantation, Florida, United States
• Suncoast Neuroscience Associates Inc. — St. Petersburg, Florida, United States
• Study site — Tampa, Florida, United States
• Neurology & Headache Specialist of Atlanta, L.L.C. — Decatur, Georgia, 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
• SUNY Upstate Medical University — Syracuse, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Raleigh Neurology Associates, PA — Raleigh, North Carolina, United States
• NeuroCare Center, Inc. — Canton, Ohio, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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