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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00050232

Enrollment

Registered

2002-12-03

Start date

2002-12-31

Completion date

2004-06-30

Last updated

2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Pseudobulbar Affect, Uncontrolled, Laughing, Crying

Brief 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.

Interventions

DRUGAVP-923

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 68 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
emotional control	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026