Safety Study of AVP-923 in the Treatment of IEED (Involuntary Emotional Expression Disorder) Also Known as Pseudobulbar Affect (Episodes of Uncontrolled Crying and/or Laughter)

An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00056524

Enrollment

600

Registered

2003-03-18

Start date

2003-02-28

Completion date

2007-06-30

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

Alzheimer's Disease, Parkinson's Disease, Stroke, Traumatic Brain Injury

Keywords

ALS, MS, CNS, AD, TBI, Dextromethorphan, IEED, Emotional

Brief summary

The purpose of this study is to evaluate the long-term safety of AVP-923 in the treatment of Involuntary Emotional Expression Disorder (IEED) also known as Pseudobulbar Affect (episodes of uncontrolled crying and/or laughter).

Detailed description

This is an open label study which means there is no placebo group. Each subject enrolled into the study will receive AVP-923.

Interventions

DRUGAVP-923

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 18 to 75 years of age, inclusive * Clinical diagnosis of PBA (pseudobulbar affect) * If female, must not be pregnant or breast feeding

Exclusion criteria

* Sensitivity to quinidine or any opiate drugs * Current or prior history of major psychiatric disturbance * Currently participated in a trial within the past 30 days

Design outcomes

Primary

Measure	Time frame
emotional control	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026