Clinical trial NCT00056524: 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)
Official title: An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Stroke
Parkinson's Disease
Traumatic Brain Injury
Keywords: ALS
MS
CNS
AD
TBI
Dextromethorphan
IEED
Emotional
Lead sponsor: Avanir Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2003-03-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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