- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01838018
Brain Perfusion in Pantothenate Kinase-associated Neurodegeneration (PKAN)
May 24, 2018 updated by: Susan J. Hayflick
Brain Perfusion in Pantothenate Kinase-Associated Neurodegeneration (PKAN)
The purpose of this study is to learn whether blood flow in the brain is normal in people with pantothenate kinase-associated neurodegeneration (PKAN).
Specifically, preliminary data suggest a region of the brain called the globus pallidus (GP), a key region affected by PKAN, may have reduced blood flow.
Standard MRI and perfusion scanning techniques will be used to learn about cerebral blood flow in the globus pallidus and compare it to blood flow in other brain regions as well as to healthy controls.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 73 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The PKAN group consists of individuals in the United States diagnosed with PKAN.
Description
Inclusion Criteria:
- diagnosis of PKAN confirmed by MRI and gene testing
- able to undergo MRI for approximately 1 hour without sedation
Exclusion Criteria:
- deep brain stimulators or other conditions that warrant avoidance of a strong magnetic field
- previous reaction to gadolinium (Gd) contrast agent
- acute or chronic kidney dysfunction
- pregnant and/or nursing at time of study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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PKAN
This group consists of individuals diagnosed with PKAN using a combination of MRI and PANK2 gene sequencing.
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Healthy volunteers
This is a control group of healthy volunteers, matched with the PKAN group for age and sex.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ASL-derived cerebral blood flow(CBF)
Time Frame: Single MRI
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The unit of analyses will be the subject and the primary comparison will be the globus pallidus CBF between PKAN and healthy controls.
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Single MRI
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Susan J Hayflick, MD, Oregon Health and Science University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2013
Primary Completion (Actual)
October 1, 2017
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
April 18, 2013
First Submitted That Met QC Criteria
April 22, 2013
First Posted (Estimate)
April 23, 2013
Study Record Updates
Last Update Posted (Actual)
May 29, 2018
Last Update Submitted That Met QC Criteria
May 24, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Heredodegenerative Disorders, Nervous System
- Neuroaxonal Dystrophies
- Pantothenate Kinase-Associated Neurodegeneration
- Nerve Degeneration
Other Study ID Numbers
- 8777
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pantothenate Kinase-associated Neurodegeneration (PKAN)
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Travere Therapeutics, Inc.TerminatedPantothenate Kinase-Associated NeurodegenerationUnited States, Canada, Czechia, France, Germany, Italy, Norway, Poland, Spain
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Ente Ospedaliero Ospedali GallieraActive, not recruitingIron Overload | Neurodegenerative DiseaseItaly
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University College, LondonUnknownMitochondrial Diseases | Dystonia, Familial | Sporadic Dystonia | Parkinson Disease, Juvenile | Neurodegeneration With Brain Iron Accumulation 5