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)

Phase 3

Completed

• Conditions: Alzheimer's Disease; Traumatic Brain Injury; Stroke; Parkinson's Disease

• Registration Number: NCT00056524
• Lead Sponsor: Avanir Pharmaceuticals

Brief Summary

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).

Detailed Description

This is an "open label" study which means there is no placebo group. Each subject enrolled into the study will receive AVP-923.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2003-03-15
• Study First Submitted QC: 2003-03-17
• Study First Posted: 2003-03-18
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-13
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
emotional control

Trial Locations

Locations (37)

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, District of Columbia, United States

Neurological Associates; 🇺🇸 Ft. 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

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