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)
An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.
2 other identifiers
interventional
600
1 country
39
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2003
Typical duration for phase_3
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 15, 2003
CompletedFirst Posted
Study publicly available on registry
March 18, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedJuly 14, 2016
July 1, 2016
4.3 years
March 15, 2003
July 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
emotional control
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
Center for Neurologic Study
La Jolla, California, 92037, United States
UCLA School of Medicine
Los Angeles, California, 90095, United States
UCSF
San Francisco, California, 94117, United States
Research Center for Clinical Studies, Inc.
Darien, Connecticut, 06820, United States
George Washington University Medical Faculty Assoc.
Washington D.C., District of Columbia, 20037, United States
Neurological Associates
Fort Lauderdale, Florida, 33334, United States
University of Miami Dept. of Neurology
Miami, Florida, 33136, United States
Miami Jewish Home & Hospital for the Aged
Miami, Florida, 33137, United States
Allied Clinical Trials
Miami, Florida, 33181, United States
Renstar Medical Research
Plantation, Florida, 33324, United States
Suncoast Neuroscience Associates Inc.
St. Petersburg, Florida, 33701, United States
Unknown Facility
Tampa, Florida, 33606, United States
Neurology & Headache Specialist of Atlanta, L.L.C.
Decatur, Georgia, 30033, United States
Consultants in Neurology LTD
Northbrook, Illinois, 60062, United States
Advanced Neurology Specialists
Great Falls, Montana, 59405, United States
Neurological Associates, P.C.
Lincoln, Nebraska, 68506, United States
Upstate Clinical Research
Albany, New York, 12205, United States
DENT Neurologic Group L.L.P.
Amherst, New York, 14266, United States
Hospital for Joint Diseases MS Care Center
New York, New York, 10003, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Raleigh Neurology Associates, PA
Raleigh, North Carolina, 27607, United States
NeuroCare Center, Inc.
Canton, Ohio, 44718, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
University Memory and Aging Center
Cleveland, Ohio, 44120, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Clinical Pharmaceutical Trials, Inc.
Tulsa, Oklahoma, 74104, United States
Lehigh Valley Neurosciences and Pain Research Center
Allentown, Pennsylvania, 18103, United States
Westmoreland Neurology
Greensburg, Pennsylvania, 15601, United States
Unknown Facility
Jenkintown, Pennsylvania, 19046, United States
MCP-Hahnemann University
Philadelphia, Pennsylvania, 19107, United States
Penn Neurological Institute
Philadelphia, Pennsylvania, 19107, United States
Neurological Associates of Delaware Valley
Upland, Pennsylvania, 19013, United States
Claghorn-Lesem Research Clinic
Bellaire, Texas, 77401, United States
Methodist Neurological Institute
Houston, Texas, 77030, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Neurology and Neurosurgery Associates of Tacoma
Tacoma, Washington, 98405, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Related Publications (1)
Pattee GL, Wymer JP, Lomen-Hoerth C, Appel SH, Formella AE, Pope LE. An open-label multicenter study to assess the safety of dextromethorphan/quinidine in patients with pseudobulbar affect associated with a range of underlying neurological conditions. Curr Med Res Opin. 2014 Nov;30(11):2255-65. doi: 10.1185/03007995.2014.940040. Epub 2014 Jul 28.
PMID: 25062507DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 15, 2003
First Posted
March 18, 2003
Study Start
February 1, 2003
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
July 14, 2016
Record last verified: 2016-07