PRISM Registry: Pseudobulbar Affect Registry Series

Stroke Clinical Trial

Official title:

PRISM Registry: Pseudobulbar Affect Registry Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366027
• Other study ID #: 11-AVR-REG-001
• Status: Completed
• Phase: N/A
• First received: June 2, 2011
• Last updated: April 15, 2014
• Start date: May 2011
• Est. completion date: September 2012

Study information

• Verified date: April 2014
• Source: Avanir Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5290
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis (ALS)
• Multiple Sclerosis
• Multiple Sclerosis (MS)
• Parkinson Disease
• Parkinson's Disease
• Sclerosis
• Stroke
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Avanir Pharmaceuticals	Aliso Viejo	California

Sponsors (1)

Lead Sponsor	Collaborator
Avanir Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of PBA (using CNS-LS)	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.	Upon Study Enrollment/Entry	No