Multiple SclerosisNCT04082468
VALIDATE: Factor VIII Trending for MS Relapse
An observational study of Multiple Sclerosis, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
Trial summary
Multiple sclerosis (MS) patients hospitalized with an acute motor or visual relapse will be consented. Factor VIII-related labs will be systematically drawn for six months. During this time, patients will be followed with clinical assessments including: Expanded Disability Status Scale (EDSS), Multiple Sclerosis… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Blood sample collection for coagulation profile
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2019to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute MS relapse patients hospitalized at St. Joseph's Hospital and Medical Center in Phoenix, Arizona
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Barrow Neurological Institute
Phoenix, Arizona, 85013
About this study
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
Multiple sclerosis (MS) patients hospitalized with an acute motor or visual relapse will be consented. Factor VIII-related labs will be systematically drawn for six months. During this time, patients will be followed with clinical assessments including: Expanded Disability Status Scale (EDSS), Multiple Sclerosis Functional Composite (MSFC), Low Contrast Sloan Letter Chart Testing, Symbol Digital Modality Test (SDMT), and NeuroQol. MRIs of the brain, cervical spine, and thoracic spine with and without contrast will be obtained. All patients will be treated with 1 gram IV solumedrol daily for five days per standard care. 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 intravenous (IV) solumedrol treatment
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Blood sample collection for coagulation profile
- Keywords
- Relapsing remitting Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collection for coagulation profileDiagnostic test
Also called Clinical data collection
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 points
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of MS relapse recovery time with elevated lab values.
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
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start13 Aug 2019
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Why it stopped: Never started enrollment due to logistics.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amiee Borazanci, MD, Principal investigator, St. Joseph's Hospital/Barrow Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082468
- Sponsor's protocol ID
- 18-500-440-30-10
- Status last verified
- Sep 2021
- First submitted
- 5 Sep 2019
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04082468
- Acronym / sponsor ID
- 18-500-440-30-10
- Conditions
- Multiple Sclerosis
- Keywords
- Relapsing remitting Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Never started enrollment due to logistics.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple sclerosis (MS) patients hospitalized with an acute motor or visual relapse will be consented. Factor VIII-related labs will be systematically drawn for six months. During this time, patients will be followed with clinical assessments including: Expanded Disability Status Scale (EDSS), Multiple Sclerosis Functional Composite (MSFC), Low Contrast Sloan Letter Chart Testing, Symbol Digital Modality Test (SDMT), and NeuroQol. MRIs of the brain, cervical spine, and thoracic spine with and without contrast will be obtained. All patients will be treated with 1 gram IV solumedrol daily for five days per standard care. 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 intravenous (IV) solumedrol 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute MS relapse patients hospitalized at St. Joseph's Hospital and Medical Center in Phoenix, Arizona
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collection for coagulation profileAlso: Clinical data collectionFactor 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 points | Diagnostic test | – |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amiee Borazanci, MD principal investigator
St. Joseph's Hospital/Barrow Neurological Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of MS relapse recovery time with elevated lab values. (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021; AzTrials last refreshed its copy on 26 Oct 2026.