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

September 12, 2023 updated by: Dignity Health Medical Foundation

VALIDATE II Study: Observational Trial Evaluating Elevated Factor VIII Related Labs in Multiple Sclerosis Relapse as a Marker for Incomplete Recovery

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The identification of blood tests that detect patients having disability provoking Multiple Sclerosis (MS) relapses in real time could lead to a new era of MS relapse treatment. The cross-talk between inflammatory and coagulation pathways in multiple sclerosis has been recognized on some level for decades. Accidental and anecdotal clinical observations suggest that excessive activation of the intrinsic coagulation pathway, namely with increased Factor VIII activity, occurs with some MS relapses, and that these are the relapses that don't recover with current standard of care treatments, leaving behind permanent disability.

To test this hypothesis that real time abnormally increased levels of Factor VIII activity related labs can identify disabling relapses in real time, nine adult patients with relapsing remitting MS with or without secondary progression will be consented and enrolled in this observational, longitudinal clinical trial. Patients will receive standard of care treatment per the investigator's discretion for their relapse, but will have additional blood tests testing Factor VIII activity, Factor VIII antigen, serum neurofilament among others drawn on days 1, 8, 22 and 90 of the study. The investigator and the patient will not know these lab test results. Patients will also have mris of the brain, cervical spine, and thoracic spine done with and without contrast as soon as possible upon study entry. On Days 1,8,22, and 90, in addition to blood tests, the patient will complete an EDSS and MSFC (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), and fill out a recovery survey. Individual blood tests, aggregate blood tests, mri findings, EDSS and MSFC individual and summed scores will be scrutinized and evaluated for the ability to identify a MS relapse and to identify a treatment-resistant MS relapse

Study Type

Observational

Enrollment (Estimated)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult relapsing remitting patients with an established or new diagnosis of relapsing remitting multiple sclerosis suffering an acute MS relapse. Patients can be on any disease modifying therapy or on no therapy. Patients who cannot have a MRI, found to have an alternative neurological explanation for their symptoms will be excluded. Patients will be enrolled from a Multiple Sclerosis clinic or from an inpatient hospital setting.

Description

Inclusion Criteria: Identified by prinicipal investigator as having an acute multiple sclerosis relapse of less than 30 days duration

-

Exclusion Criteria:

Inability to have a MRI

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation of Factor VIII activity, Factor VIII with MS relapse
Time Frame: 90 days
90 days
Correlation of Factor VIII activity, Factor VIII antigen with MS relapse incomplete recovery
Time Frame: 90 days
90 days
Correlation of additional labs with MS relapse or MS relapse incomplete recovery
Time Frame: 90 days
90 days
Correlation of MRI findings with MS relapse and MS relapse recovery
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dignity Health Medical Foundation

Collaborators

Dolly Roy MD PhD (author)
J. Michael Menke (statistician)
Sabeen Lulu MD (Principal Investigator)

Investigators

  • Principal Investigator: Sabeen B Lulu, MD, Dignity Health Medical Foundation

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 (Estimated)

September 12, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Validate II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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