PRISM Registry: Pseudobulbar Affect Registry Series

Sponsor

Avanir Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01366027

Collaborator

(none)

5,290

Enrollment

Location

16.1

Duration (Months)

329.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

PBA is a neurologic condition that is estimated to impact over a million patients and their families in the United States. PBA occurs secondary to an otherwise unrelated neurologic disease or injury, and manifests as involuntary, frequent, and disruptive outbursts of crying and/or laughing. Progress has been made in better understanding this debilitating condition, but much more needs to be done. That's why a new PBA patient registry, PRISM (Pseudobulbar Affect RegIstry Series), has been initiated.

The goal of PRISM is to establish the prevalence and quality of life (QOL) impact of PBA in patients with underlying neurologic conditions including

Alzheimer's disease
Amyotrophic lateral sclerosis
Multiple sclerosis
Parkinson's disease
Stroke
Traumatic brain injury

Because this is an observational registry, it doesn't require you to intervene with any specific treatment or procedure. Your participation allows the PRISM registry to collect and analyze data from your site and also compare it to national numbers captured in the PRISM registry about PBA across all of the major at-risk neurologic populations.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease Amyotrophic Lateral Sclerosis (ALS) Multiple Sclerosis (MS) Parkinson's Disease Stroke Traumatic Brain Injury

Study Design

Study Type:

Observational

Actual Enrollment :

5290 participants

Official Title:

PRISM Registry: Pseudobulbar Affect Registry Series

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Outcome Measures

Primary Outcome Measures

Prevalence of PBA (using CNS-LS) [Upon Study Enrollment/Entry]
The objective of the registry is to determine the prevalence of pseudobulbar affect (PBA) in patients with certain underlying neurologic conditions: Alzheimer's Disease (AD), Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD), Stroke (STR), and Traumatic Brain Injury (TBI). Presence of PBA symptoms was defined as CNS-LS score >=13.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All participants must have underlying neurologic conditions known to be risk factors of PBA: Alzheimer's Disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's Disease, Stroke, and Traumatic Brain Injury.
The population for this study will be 18 years and over