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)

Stroke Clinical Trial

Official title:

An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056524
• Other study ID #: 02-AVR-107
• Secondary ID: AVP-923
• Status: Completed
• Phase: Phase 3
• First received: March 15, 2003
• Last updated: July 13, 2016
• Start date: February 2003
• Est. completion date: June 2007

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

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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Brain Injuries
• Parkinson Disease
• Parkinson's Disease
• Stroke
• Traumatic Brain Injury

Intervention

Drug:
• AVP-923

Locations

Country	Name	City	State
United States	Upstate Clinical Research	Albany	New York
United States	Lehigh Valley Neurosciences and Pain Research Center	Allentown	Pennsylvania
United States	DENT Neurologic Group L.L.P.	Amherst	New York
United States	Claghorn-Lesem Research Clinic	Bellaire	Texas
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	NeuroCare Center, Inc.	Canton	Ohio
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Memory and Aging Center	Cleveland	Ohio
United States	Research Center for Clinical Studies, Inc.	Darien	Connecticut
United States	Neurology & Headache Specialist of Atlanta, L.L.C.	Decatur	Georgia
United States	Neurological Associates	Ft. Lauderdale	Florida
United States	Advanced Neurology Specialists	Great Falls	Montana
United States	Westmoreland Neurology	Greensburg	Pennsylvania
United States	Methodist Neurological Institute	Houston	Texas
United States	Center for Neurologic Study	La Jolla	California
United States	Neurological Associates, P.C.	Lincoln	Nebraska
United States	UCLA School of Medicine	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Allied Clinical Trials	Miami	Florida
United States	Miami Jewish Home & Hospital for the Aged	Miami	Florida
United States	University of Miami Dept. of Neurology	Miami	Florida
United States	Hospital for Joint Diseases MS Care Center	New York	New York
United States	Consultants in Neurology LTD	Northbrook	Illinois
United States	MCP-Hahnemann University	Philadelphia	Pennsylvania
United States	Penn Neurological Institute	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	Renstar Medical Research	Plantation	Florida
United States	Raleigh Neurology Associates, PA	Raleigh	North Carolina
United States	UCSF	San Francisco	California
United States	Suncoast Neuroscience Associates Inc.	St. Petersburg	Florida
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Neurology and Neurosurgery Associates of Tacoma	Tacoma	Washington
United States	Clinical Pharmaceutical Trials, Inc.	Tulsa	Oklahoma
United States	Neurological Associates of Delaware Valley	Upland	Pennsylvania
United States	George Washington University Medical Faculty Assoc.	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Avanir Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	emotional control