PRISM Registry: Pseudobulbar Affect Registry Series
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|ClinicalTrials.gov Identifier: NCT01366027|
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : April 16, 2014
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
- 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|
|Alzheimer's Disease Amyotrophic Lateral Sclerosis (ALS) Multiple Sclerosis (MS) Parkinson's Disease Stroke Traumatic Brain Injury|
|Study Type :||Observational|
|Actual Enrollment :||5290 participants|
|Official Title:||PRISM Registry: Pseudobulbar Affect Registry Series|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
- Prevalence of PBA (using CNS-LS) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366027
|United States, California|
|Aliso Viejo, California, United States, 92656|
|Study Chair:||Randall Kaye, MD||Avanir Pharmaceuticals|