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Pilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ) Versus ACTHar Gel Five Days SQ for the Treatment of MS Exacerbations
This pilot study is designed as a prospective cohort study to determine whether standard subcutaneous (SQ) Highly-Purified (HP) Acthar Gel 14 days is superior to SQ HP Acthar Gel 5 days in the treatment of relapses or attacks in multiple sclerosis (MS).
Details
| Lead sponsor | The University of Texas Health Science Center, Houston |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 25 |
| Start date | 2013-04 |
| Completion | 2014-08 |
Conditions
- Multiple Sclerosis (MS)
Interventions
- H.P. Acthar Gel (repository corticotropin injection)
Primary outcomes
- Comparison of EDSS Mean Recovery between 5-day vs 14-day SQ 80 IU ACTHar Gel therapy groups — 28 Days (with 90 day follow-up)
To determine whether a standard 14 day course of SQ 80 IU ACTHar Gel therapy might be superior (in twice as many patients) to treatment with 5 day SQ regimen for ACTHar Gel as determined by EDSS mean recovery from Day 0 (time of steroid therapy initiation) to Day 28 (and day 90).
Countries
United States