The purpose of this study is to compare intramuscular (IM) ACTH (adrenocorticotropin hormone) and intravenous (IV) methylprednisolone (Solumedrol) for the treatment of an MS (Multiple Sclerosis) relapse (exacerbation) after sub-response to an initial 3 day course of IV methylprednisolone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
IV 1000 mg daily for 3 days
IM ACTH 80 mg/day for 5 days.
IV placebo (saline) daily for 3 days.
Neurologique Foundation, Inc.
Ponte Vedra, Florida, United States
Improvement in EDSS (Expanded Disability Status Scale) and Kurtzke Functional Scale (to assess individual disabilities).
Time frame: 12 weeks
Improvement in MSFC (Multiple Sclerosis Functional Composite)18 and its three individual components.
Time frame: 12 weeks
Safety and tolerability of ACTH and MP in patients with an acute relapse of multiple sclerosis after sub-response to an initial course of intravenous methylprednisolone.
Time frame: 12 weeks
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IM placebo (saline) daily for 5 days.