Efficacy Study of Adrenocorticotropin Hormone to Treat Multiple Sclerosis (MS) Relapses After Sub-responding to an Initial 3 Day Course of Intravenous (IV) Methylprednisolone (RECLAIM)
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.
Other: IV placebo
Other: IM placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Relative Efficacy of Repeat Course of Intravenous methyLprednisolone and Intramuscular ACTH in the Treatment of Acute Relapse of Multiple Sclerosis After Sub Response to Initial Course of Intravenous Methylprednisolone (RECLAIM): a Single Center Pilot Study|
- Improvement in EDSS (Expanded Disability Status Scale) and Kurtzke Functional Scale (to assess individual disabilities). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Improvement in MSFC (Multiple Sclerosis Functional Composite)18 and its three individual components. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2009|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Methylprednisolone
Intravenous (IV) methylprednisolone (Solumedrol) 1000 mg daily for 3 days.
IV 1000 mg daily for 3 days
Other Name: SolumedrolOther: IM placebo
IM placebo (saline) daily for 5 days.
Active Comparator: ACTH
Intramuscular (IM) ACTH 80 mg/day for 5 days.
IM ACTH 80 mg/day for 5 days.
Other Names:Other: IV placebo
IV placebo (saline) daily for 3 days.
|United States, Florida|
|Neurologique Foundation, Inc.|
|Ponte Vedra, Florida, United States, 32082|
|Principal Investigator:||Daniel Kantor, MD, BSE||Neurologique Foundation, Inc.|