PRISM Registry: Pseudobulbar Affect Registry Series

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01366027
First received: June 2, 2011
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


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

Study Type: Observational
Official Title: PRISM Registry: Pseudobulbar Affect Registry Series

Resource links provided by NLM:


Further study details as provided by Avanir Pharmaceuticals:

Primary Outcome Measures:
  • Prevalence of PBA (using CNS-LS) [ Time Frame: Upon Study Enrollment/Entry ] [ Designated as safety issue: No ]
    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.


Enrollment: 5290
Study Start Date: May 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The population for this study will be 18 years and over

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366027

Locations
United States, California
Avanir Pharmaceuticals
Aliso Viejo, California, United States, 92656
Sponsors and Collaborators
Avanir Pharmaceuticals
Investigators
Study Chair: Randall Kaye, MD Avanir Pharmaceuticals
  More Information

No publications provided

Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01366027     History of Changes
Other Study ID Numbers: 11-AVR-REG-001
Study First Received: June 2, 2011
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Avanir Pharmaceuticals:
pseudobulbar affect

Additional relevant MeSH terms:
Alzheimer Disease
Amyotrophic Lateral Sclerosis
Multiple Sclerosis
Parkinson Disease
Sclerosis
Stroke
Motor Neuron Disease
Brain Injuries
Wounds and Injuries
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Spinal Cord Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
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

ClinicalTrials.gov processed this record on July 22, 2014