PRISM Registry: Pseudobulbar Affect Registry Series

NCT01366027 | Completed

• 1 other identifier: 11-AVR-REG-001
• Study Type: observational
• Target: 5,290
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pseudobulbar affect

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population for this study will be 18 years and over

You may qualify if:

• 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

Sponsors & Collaborators

• Avanir Pharmaceuticals: lead

Study Sites (1)

Avanir Pharmaceuticals

Aliso Viejo, California, 92656, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Amyotrophic Lateral Sclerosis; Multiple Sclerosis; Parkinson Disease; Stroke; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Spinal Cord Diseases; Motor Neuron Disease; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Randall Kaye, MD

  Avanir Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 3, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 16, 2014

Record last verified: 2014-04

Locations

US (1)