- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04082468
VALIDATE: Factor VIII Trending for MS Relapse
Observational Trial Evaluating Whether Elevated Factor VIII Activity During Multiple Sclerosis Relapses Serves as a Marker for Solumedrol-Resistance and Incomplete Relapse Recovery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The identification of blood tests that detect patients having Multiple Sclerosis (MS) relapses in real time could lead to a new era of MS relapse treatment. Accidental, anecdotal clinical observations suggest that transient upregulation of the intrinsic coagulation pathway, namely with elevated von Willebrand Factor antigen levels (vWF) and increased Factor VIII activity, occur with some MS relapses and that the higher the elevated plasma values, the more glucocorticoid therapy required to achieve clinical improvement.
Ten adult patients with relapsing remitting MS with or without secondary progression will be consented and enrolled in this longitudinal clinical trial. As a standard of care all patients will be treated daily with one gram IV solumedrol for five days, and all patients will have performed standard MRI's of the brain, cervical spine, and thoracic spine with and without IV contrast during hospital admission, which may occur after Solumedrol treatment.
In addition to this standard of care, patients will have a panel of labs drawn on Days: 1 (prior to any solumedrol treatment), 7, 15, 30, 45, 60, 90, 135, and 180. Neurological clinical assessments, comprising of assessing the EDSS score, the MSFC index (that looks at ambulation, hand/arm coordination, and cognitive function, comprised of the 25 foot timed walking tests, with and without any assistive devices if possible), LCSLC test, SDMT, and Neuro QoL will be conducted on Days: 1, 7, 30, 90, 180. Individual and aggregate laboratory values, neurological clinical assessment results, and MRI findings will be correlated for the presence of a MS relapse, severity of relapse, and extent of recovery from the relapse. Patients and evaluators will be blinded to the lab results.
Study Type
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85013
- Barrow Neurological Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients aged 18-65 with an established diagnosis of relapsing remitting multiple sclerosis (RRMS);
- Patients with RRMS hospitalized at St. Joseph's Hospital and Medical Center in Phoenix, Arizona for an acute relapse affecting strength or vision;
- Patients may or may not be on disease modifying treatment;
- Entry EDSS score up to 7.0.
Exclusion Criteria:
- Patients unable to have an MRI;
- Patients taking any heparin products, warfarin (Coumadin), apixiban (Eliquis), dabigatran (Pradaxa), or rivaroxaban (Xarelto);
- If stroke, tumor or other non-MS related cause is identified as the source of the patient's neurological issues.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of MS relapse recovery time with elevated lab values.
Time Frame: 180 days
|
Extent of relapse recovery across a variety of measures will be correlated with collected lab values and neurological assessments in an attempt to identify a positive correlation between incomplete recovery and solumedrol resistance with abnormally elevated lab values involving the vWF antigen and Factor VIII pathways
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180 days
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Collaborators and Investigators
Investigators
- Principal Investigator: Amiee Borazanci, MD, St. Joseph's Hospital/Barrow Neurological Institute
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-500-440-30-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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