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)
|ClinicalTrials.gov Identifier: NCT00947895|
Recruitment Status : Terminated (Study reached halfway point in approximately one year time period and was halted to analyze data.)
First Posted : July 28, 2009
Last Update Posted : March 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Methylprednisolone Drug: ACTH Other: IV placebo Other: IM placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
Active Comparator: Methylprednisolone
Intravenous (IV) methylprednisolone (Solumedrol) 1000 mg daily for 3 days.
IV 1000 mg daily for 3 days
Other Name: Solumedrol
Other: 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: IV placebo
IV placebo (saline) daily for 3 days.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947895
|United States, Florida|
|Neurologique Foundation, Inc.|
|Ponte Vedra, Florida, United States, 32082|
|Principal Investigator:||Daniel Kantor, MD||Neurologique Foundation, Inc.|