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Observational Trial Evaluating Elevated Factor VIII Related Labs as a Biomarker for Incomplete Relapse Recovery

NCT05926167 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 9

Last updated 2023-09-14

No results posted yet for this study

Summary

Nine Multiple Sclerosis (MS) patients suffering an acute relapse from the outpatient or inpatient settings will be consented to be followed prospectively for three months post relapse, in an effort to identify markers of incomplete relapse recovery. Factor VIII-related labs will be drawn for three months without influencing standard of care treatment decisions. During this time, patients will be followed with clinical and diagnostic assessments in addition to blood tests including: Expanded Disability Status Scale (EDSS), Multiple Sclerosis Functional Composite (MSFC), recovery surveys, and MRIs of the brain, cervical spine, and thoracic spine with and without contrast. Clinical, imaging, and Factor VIII-related lab data individually or in aggregate will be correlated with relapse presence, severity, and extent of recovery following standard treatment interventions.

Conditions

Interventions

DIAGNOSTIC_TEST

blood tests drawn days 1, 8, 22 and 90 of the study

Blood tests related to Factor VIII activity that are not a part of standard of care

Sponsors & Collaborators

  • Dignity Health Medical Foundation

    lead OTHER

Principal Investigators

  • Sabeen B Lulu, MD · Dignity Health Medical Foundation

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-12
Primary Completion
2024-05-31
Completion
2024-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05926167 on ClinicalTrials.gov