drugset / Trial / NCT01049451

Pulse ACTH vs. MP for MS

NCT01049451

Phase 1 Completed 23 enrolled University of Southern California
RandomizedParallel-groupSingle-blindTreatment

Summary

We hypothesize that corticotropin or adrenocorticotrophic hormone (ACTH), administered as Acthar Gel® (MANUFACTURER NAME) is effective in the control of clinical disease activity as a pulse therapy for relapsing-remitting MS when added to standard treatment with beta-interferon. We wish to determine whether ACTH, when administered as clustered monthly intramuscular injections (monthly pulse therapy) as add-on to beta-interferons, may be a safe and effective alternative to monthly pulse therapy with MP. In addition, we hypothesize that pulse therapy with ACTH alters immune function to favor a regulatory, rather than a pro-inflammatory T cell environment.

Timeline

Start
2009-11
Primary completion
2013-06
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject ACTH Unknown 80 iu Intramuscular
Comparator Methylprednisolone Other / unclassified 1 g Intravenous

Indications