PRISM Registry: Pseudobulbar Affect Registry Series
Primary Purpose
Alzheimer's Disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS)
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Alzheimer's Disease focused on measuring pseudobulbar affect
Eligibility Criteria
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
Sites / Locations
- Avanir Pharmaceuticals
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01366027
Brief Title
PRISM Registry: Pseudobulbar Affect Registry Series
Official Title
PRISM Registry: Pseudobulbar Affect Registry Series
Study Type
Observational
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avanir Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease, Stroke, Traumatic Brain Injury
Keywords
pseudobulbar affect
7. Study Design
Enrollment
5290 (Actual)
Primary Outcome Measure Information:
Title
Prevalence of PBA (using CNS-LS)
Description
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.
Time Frame
Upon Study Enrollment/Entry
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Population Description
The population for this study will be 18 years and over
Sampling Method
Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall Kaye, MD
Organizational Affiliation
Avanir Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Avanir Pharmaceuticals
City
Aliso Viejo
State/Province
California
ZIP/Postal Code
92656
Country
United States
12. IPD Sharing Statement
Learn more about this trial
PRISM Registry: Pseudobulbar Affect Registry Series
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