drugset / Trial / NCT00050232

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

NCT00050232 ↗

Phase 3 Completed 96 enrolled Avanir Pharmaceuticals
RandomizedSingle-groupDouble-blindTreatment

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.

Timeline

Start
2002-12
Primary completion
2004-06
Completion
2004-06

Outcome

Met primary endpoint

paper Patients receiving DM/Q had greater reductions in Center for Neurologic Study-Lability Scale scores than those receiving placebo (p < 0.0001) at all clinic visits PMID 16634036 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dextromethorphan Unknown — —
Subject Quinidine Small molecule — —

Indications