ClinicalTrials.Veeva

Menu

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)

Avanir Pharmaceuticals logo

Avanir Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

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

Treatments

Drug: AVP-923

Study type

Interventional

Funder types

Industry

Identifiers

NCT00056524
02-AVR-107
AVP-923

Details and patient eligibility

About

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).

Full description

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

Enrollment

600 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

39

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems