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

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Communication Crying Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Laughter Nervous System Diseases Nonverbal Communication

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Barrow Neurological Institute, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AVP-923

Drug

Primary outcomes

emotional control

Sponsors and collaborators

Lead sponsor

Avanir Pharmaceuticals

Industry

Registry information

Important dates

Study start: 2002
Primary completion: 2004
Study completion: 2004
First posted: Dec 3, 2002
Registry last updated: Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed