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)

NCT00056524 — Phase 3, Completed, 600 participants, Avanir Pharmaceuticals
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An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.

RegistryNCT00056524
StatusCompleted
PhasePhase 3
Study typeInterventional; non randomized, single group, masking: none, treatment
Enrollment600 (Estimated)
SponsorAvanir Pharmaceuticals (Industry)
ConditionsAlzheimer's Disease, Stroke, Parkinson's Disease, Traumatic Brain Injury
InterventionsAVP-923 (Drug)
Datesstart 2003-02-01, primary completion 2007-06-01, completion 2007-06-01, first posted 2003-03-18, last updated 2016-07-14
Locations39 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Alzheimer's Disease All trials for Stroke All trials of AVP-923

-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).

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+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.

+Arms and interventions

  • AVP-923 (Drug)

+Outcome measures

Primary outcomes

  • emotional control

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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

+Locations (39)

FacilityCityCountryStatus
Barrow Neurological InstitutePhoenix, ArizonaUnited States
Center for Neurologic StudyLa Jolla, CaliforniaUnited States
UCLA School of MedicineLos Angeles, CaliforniaUnited States
UCSFSan Francisco, CaliforniaUnited States
Research Center for Clinical Studies, Inc.Darien, ConnecticutUnited States
George Washington University Medical Faculty Assoc.Washington D.C., District of ColumbiaUnited States
Neurological AssociatesFort Lauderdale, FloridaUnited States
University of Miami Dept. of NeurologyMiami, FloridaUnited States
Miami Jewish Home & Hospital for the AgedMiami, FloridaUnited States
Allied Clinical TrialsMiami, FloridaUnited States
Renstar Medical ResearchPlantation, FloridaUnited States
Suncoast Neuroscience Associates Inc.St. Petersburg, FloridaUnited States
Tampa, FloridaUnited States
Neurology & Headache Specialist of Atlanta, L.L.C.Decatur, GeorgiaUnited States
Consultants in Neurology LTDNorthbrook, IllinoisUnited States
Advanced Neurology SpecialistsGreat Falls, MontanaUnited States
Neurological Associates, P.C.Lincoln, NebraskaUnited States
Upstate Clinical ResearchAlbany, New YorkUnited States
DENT Neurologic Group L.L.P.Amherst, New YorkUnited States
Hospital for Joint Diseases MS Care CenterNew York, New YorkUnited States
SUNY Upstate Medical UniversitySyracuse, New YorkUnited States
Carolinas Medical CenterCharlotte, North CarolinaUnited States
Raleigh Neurology Associates, PARaleigh, North CarolinaUnited States
NeuroCare Center, Inc.Canton, OhioUnited States
MetroHealth Medical CenterCleveland, OhioUnited States
University Memory and Aging CenterCleveland, OhioUnited States
The Cleveland Clinic FoundationCleveland, OhioUnited States
Clinical Pharmaceutical Trials, Inc.Tulsa, OklahomaUnited States
Lehigh Valley Neurosciences and Pain Research CenterAllentown, PennsylvaniaUnited States
Westmoreland NeurologyGreensburg, PennsylvaniaUnited States
Jenkintown, PennsylvaniaUnited States
MCP-Hahnemann UniversityPhiladelphia, PennsylvaniaUnited States
Penn Neurological InstitutePhiladelphia, PennsylvaniaUnited States
Neurological Associates of Delaware ValleyUpland, PennsylvaniaUnited States
Claghorn-Lesem Research ClinicBellaire, TexasUnited States
Methodist Neurological InstituteHouston, TexasUnited States
Fletcher Allen Health CareBurlington, VermontUnited States
Neurology and Neurosurgery Associates of TacomaTacoma, WashingtonUnited States
University of WisconsinMadison, WisconsinUnited States

+Publications

  • Results publication: 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 25062507