Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05926167 |
Other study ID # |
Validate II |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 12, 2023 |
Est. completion date |
December 2024 |
Study information
Verified date |
September 2023 |
Source |
Dignity Health Medical Foundation |
Contact |
Dolly B Roy, MD PhD |
Phone |
9165362048 |
Email |
dollybroy[@]yahoo.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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