VALIDATE: Factor VIII Trending for MS Relapse
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|ClinicalTrials.gov Identifier: NCT04082468|
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Diagnostic Test: Blood sample collection for coagulation profile|
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 :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Observational Trial Evaluating Whether Elevated Factor VIII Activity During Multiple Sclerosis Relapses Serves as a Marker for Solumedrol-Resistance and Incomplete Relapse Recovery|
|Actual Study Start Date :||August 13, 2019|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||March 1, 2022|
- Diagnostic Test: Blood sample collection for coagulation profile
Factor VIII Activity Level, Factor VIII Antigen Level, Interleukin 6, vWF Antigen Level, Thrombin Activity, Protein C Activity, Protein C Antigen Level, CRP, PT/PTT/INR ,T & B lymphocyte panel at above time pointsOther Name: Clinical data collection
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082468
|Contact: Mary Thornton, RNfirstname.lastname@example.org|
|Contact: Stacey Lent||602-406-6291||Stacey.email@example.com|
|United States, Arizona|
|Barrow Neurological Institute||Recruiting|
|Phoenix, Arizona, United States, 85013|
|Contact: Mary Thornton, RN 602-406-6287 firstname.lastname@example.org|
|Contact: Stacy Lent 602-406-6291 Stacey.email@example.com|
|Principal Investigator: Aimee Borazanci, MD|
|Sub-Investigator: Dolly Roy, MD, PhD|
|Principal Investigator:||Amiee Borazanci, MD||St. Joseph's Hospital/Barrow Neurological Institute|