Alzheimer's DiseaseNCT01366027
PRISM Registry: Pseudobulbar Affect Registry Series
An observational study of Alzheimer's Disease and Amyotrophic Lateral Sclerosis (ALS), run by Avanir Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer's Disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS)
- How many people
- 5,290 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population for this study will be 18 years and over
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Avanir Pharmaceuticals
Aliso Viejo, California, 92656
About this study
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
Read more
- 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
- Medical subject headings
- Alzheimer Disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson Disease, Stroke, Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Upon Study Enrollment/Entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 5,290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avanir Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randall Kaye, MD, Study chair, Avanir Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366027
- Sponsor's protocol ID
- 11-AVR-REG-001
- Status last verified
- Apr 2014
- First submitted
- 2 Jun 2011
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRISM Registry: Pseudobulbar Affect Registry Series
- ClinicalTrials.gov ID
- NCT01366027
- Acronym / sponsor ID
- 11-AVR-REG-001
- Conditions
- Alzheimer's Disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease, Stroke, Traumatic Brain Injury
- Keywords
- pseudobulbar affect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,290 participants (actual)
- Lead sponsor
- Avanir PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population for this study will be 18 years and over
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall Kaye, MD study chair
Avanir Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Amyotrophic Lateral Sclerosis (ALS), run by Avanir Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of PBA (using CNS-LS) (time frame: Upon Study Enrollment/Entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2014.