Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients

NCT00050232 — Phase 3, Completed, 96 participants, Avanir Pharmaceuticals
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RegistryNCT00050232
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, single group, masking: double, treatment
Enrollment96
SponsorAvanir Pharmaceuticals (Industry)
ConditionsMultiple Sclerosis
InterventionsAVP-923 (Drug)
Datesstart 2002-12-01, primary completion 2004-06-01, completion 2004-06-01, first posted 2002-12-03, last updated 2016-07-14
Locations20 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Multiple Sclerosis All trials of AVP-923

-Summary

Pseudobulbar Affect is a condition characterized by frequent episodes of laughing and crying out of proportion. Other terms used to describe this condition include emotional lability, emotionalism, emotion incontinence, emotional discontrol, excessive emotionalism and pathological laughing and crying. AVP-923 is a new experimental drug that may assist in the reduction of uncontrolled episodes. This study will test the safety and efficacy of AVP-923 in the treatment of MS patients suffering from pseudobulbar affect.

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+Arms and interventions

  • AVP-923 (Drug)

+Outcome measures

Primary outcomes

  • emotional control

+Eligibility

Sex: All, ages: 18 Years to 68 Years

Inclusion Criteria:

* 18 to 68 years of age
* Confirmed diagnosis of Multiple Sclerosis
* Clinical history of pseudobulbar affect

Exclusion Criteria:

* Sensitivity to quinidine or opiate drugs
* Recent diagnosed within 2 months with Multiple Sclerosis
* Patient on anti-depressants
* Patient with liver or kidney disease
* Patient with hypotension

+Locations (20)

FacilityCityCountryStatus
Barrow Neurological InstitutePhoenix, ArizonaUnited States
George Washington University Medical Faculty AssociatesWashington D.C., District of ColumbiaUnited States
Neurological AssociatesFort Lauderdale, FloridaUnited States
Neurology & Headache Specialist of Atlanta, L.L.C.Decatur, GeorgiaUnited States
Radiant Research Alexian BrothersElk Grove Village, IllinoisUnited 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
Institute for Human PerformanceSyracuse, New YorkUnited States
Raleigh Neurology Associates, P.A.Raleigh, North CarolinaUnited States
NeuroCare Center, Inc.Canton, OhioUnited States
Leheigh Valley Neurosciences and Pain Research CenterAllentown, PennsylvaniaUnited States
Westmorland NeurologyGreensburg, PennsylvaniaUnited States
Neurological Associates of Delaware ValleyUpland, PennsylvaniaUnited States
FACH-UHC Department of Neurological ServicesBurlington, VermontUnited States
Swedish Medical CenterSeattle, WashingtonUnited States
Neurology and Neurosurgery Associates of TacomaTacoma, WashingtonUnited States

+Publications

  • Results publication: Panitch HS, Thisted RA, Smith RA, Wynn DR, Wymer JP, Achiron A, Vollmer TL, Mandler RN, Dietrich DW, Fletcher M, Pope LE, Berg JE, Miller A; Psuedobulbar Affect in Multiple Sclerosis Study Group. Randomized, controlled trial of dextromethorphan/quinidine for pseudobulbar affect in multiple sclerosis. Ann Neurol. 2006 May;59(5):780-7. doi: 10.1002/ana.20828. PMID 16634036