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)
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|