Progressive Supranuclear PalsyNCT00431301
Risk Factors for Progressive Supranuclear Palsy (PSP)
An observational study of Progressive Supranuclear Palsy, run by University of Louisville at 10 sites in 2 countries.
Trial summary
Progressive supranuclear palsy (PSP) is the most common atypical parkinsonian movement disorder. This study will determine the role of specific genetic, occupational and environmental components in the development of PSP by evaluating patients with this disorder and age and gender matched controls. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Progressive Supranuclear Palsy
- How many people
- 942 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Aug 2006to Jun 2013
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with clinically diagnosed Progressive Supranuclear Palsy and healthy controls
Who may be able to join
- PSP patients able to visit one of the screening sites for diagnostic confirmation and able to participate in a one hour telephone interview
Who cannot join
- No other major neurological disorders
- Unable to communicate by telephone
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Emory College of Medicine
Atlanta, Georgia, 30322
University of Colorado
Aurora, Colorado, 80045
University of Maryland
Baltimore, Maryland, 21201
University of Alabama, Birmingham
Birmingham, Alabama, 35233
Rush University
Chicago, Illinois, 60611
Case Western University
Cleveland, Ohio, 44106
University of Kansas
Kansas City, Kansas, 66160
UCLA
Los Angeles, California, 90095-1759
University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Genetic and Environmental Risk Factors for PSP
Progressive supranuclear palsy (PSP) is the most common atypical parkinsonian movement disorder. This study will determine the role of specific genetic, occupational and environmental components in the development of PSP by evaluating patients with this disorder and age and gender matched controls.
Read the detailed description
This proposal will determine: (1) if there is an association between PSP and specific genes of interest; (2) if there is an association between PSP and occupational and/or environmental chemical exposures functionally or structurally similar to known parkinsonian toxicants; and (3) if hypertension or traumatic brain injury prior to symptom-onset is associated with PSP. To disentangle the complex etiology of PSP, this case-control multicenter study involves 500 PSP cases, 500 age/gender matched primary controls, and 500 secondary controls for genetic confirmation. Understanding the etiology of PSP may also help explain the causes of other related diseases such as Alzheimer's disease. This multidisciplinary team of movement disorder specialists, epidemiologists, geneticists, biostatisticians, industrial hygienist and toxicologist is well suited to unravel the etiology of PSP.
- Conditions
- Progressive Supranuclear Palsy
- Keywords
- Progressive Supranuclear Palsy, Epidemiology, Case-Control, Genetic, Environmental, Neurodegenerative Disease, Movement Disorders, Atypical Parkinsonism, Parkinson Plus, Steele-Richardson-Olszewski, PSP
- Medical subject headings
- Supranuclear Palsy, Progressive, Neurodegenerative Diseases, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | PSP Cases | |
| Control | Healthy Controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startAug 2006
- Primary completionFeb 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 942 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Irene Litvan, M.D., Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431301
- Sponsor's protocol ID
- 1R01AG024040-01A2
- Other IDs
- 1R01AG024040-01A2
- Status last verified
- Apr 2017
- First submitted
- 1 Feb 2007
- Last updated
- 10 Apr 2017
- Results posted
- No
Publications
Kelley KD, Checkoway H, Hall DA, Reich SG, Cunningham C, Litvan I. Traumatic Brain Injury and Firearm Use and Risk of Progressive Supranuclear Palsy Among Veterans. Front Neurol. 2018 Jun 20;9:474. doi: 10.3389/fneur.2018.00474. eCollection 2018.
PubMed 29973911
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Environmental Risk Factors for PSP
- ClinicalTrials.gov ID
- NCT00431301
- Acronym / sponsor ID
- 1R01AG024040-01A2
- Conditions
- Progressive Supranuclear Palsy
- Keywords
- Progressive Supranuclear Palsy, Epidemiology, Case-Control, Genetic, Environmental, Neurodegenerative Disease, Movement Disorders, Atypical Parkinsonism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 942 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Aug 2006
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Feb 2007 (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.
Progressive supranuclear palsy (PSP) is the most common atypical parkinsonian movement disorder. This study will determine the role of specific genetic, occupational and environmental components in the development of PSP by evaluating patients with this disorder and age and gender matched controls.
Detailed description
This proposal will determine: (1) if there is an association between PSP and specific genes of interest; (2) if there is an association between PSP and occupational and/or environmental chemical exposures functionally or structurally similar to known parkinsonian toxicants; and (3) if hypertension or traumatic brain injury prior to symptom-onset is associated with PSP. To disentangle the complex etiology of PSP, this case-control multicenter study involves 500 PSP cases, 500 age/gender matched primary controls, and 500 secondary controls for genetic confirmation. Understanding the etiology of PSP may also help explain the causes of other related diseases such as Alzheimer's disease. This multidisciplinary team of movement disorder specialists, epidemiologists, geneticists, biostatisticians, industrial hygienist and toxicologist is well suited to unravel the etiology of PSP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –PSP Cases |
| Control | – | –Healthy Controls |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinically diagnosed Progressive Supranuclear Palsy and healthy controls
Key inclusion criteria (1 listed)
- PSP patients able to visit one of the screening sites for diagnostic confirmation and able to participate in a one hour telephone interview
Key exclusion criteria (2 listed)
- No other major neurological disorders
- Unable to communicate by telephone
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
Not reported in the source record.
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 10 Apr 2017.
- Derived from this study: PubMed 29973911Kelley KD, Checkoway H, Hall DA, Reich SG, Cunningham C, Litvan I. Traumatic Brain Injury and Firearm Use and Risk of Progressive Supranuclear Palsy Among Veterans. Front Neurol. 2018 Jun 20;9:474. doi: 10.3389/fneur.2018.00474. eCollection 2018.
- PSP study information websiteLink provided by the sponsor.
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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.
Irene Litvan, M.D. principal investigator
University of Louisville
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progressive Supranuclear Palsy, run by University of Louisville at 10 sites in 2 countries.
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 1 inclusion and 2 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 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00431301, which also lists 1 linked publication.
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 10 Apr 2017.