Last reviewed · How we verify
NCT04082468
VALIDATE: Factor VIII Trending for MS Relapse
trial testing Blood sample collection for coagulation profile in Multiple Sclerosis. Withdrawn.
1 December 2021
Quick facts
| Lead sponsor | St. Joseph's Hospital and Medical Center, Phoenix |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 13 August 2019 |
| Primary completion | 1 December 2021 |
| Estimated completion | 1 March 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Blood sample collection for coagulation profile
Conditions studied
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Who can join
Adults 18 to 65, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04082468
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04082468 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by St. Joseph's Hospital and Medical Center, Phoenix
- Last refreshed: 21 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04082468.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing