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

Avanir Pharmaceuticals96 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

AVP-923DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 68 Years

Medical Language ↔ Plain English

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)

Barrow Neurological Institute

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

emotional control

Data from ClinicalTrials.gov

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