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PRISM Registry: Pseudobulbar Affect Registry Series

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01366027
First Posted: June 3, 2011
Last Update Posted: April 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Avanir Pharmaceuticals
June 2, 2011
June 3, 2011
April 16, 2014
May 2011
September 2012   (Final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT01366027 on ClinicalTrials.gov Archive Site
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PRISM Registry: Pseudobulbar Affect Registry Series
PRISM Registry: Pseudobulbar Affect Registry Series

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.

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Observational
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Probability Sample
The population for this study will be 18 years and over
  • Alzheimer's Disease
  • Amyotrophic Lateral Sclerosis (ALS)
  • Multiple Sclerosis (MS)
  • Parkinson's Disease
  • Stroke
  • Traumatic Brain Injury
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5290
September 2012
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01366027
11-AVR-REG-001
No
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Avanir Pharmaceuticals
Avanir Pharmaceuticals
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Study Chair: Randall Kaye, MD Avanir Pharmaceuticals
Avanir Pharmaceuticals
April 2014