Efficacy Study of Adrenocorticotropin Hormone to Treat Multiple Sclerosis (MS) Relapses After Sub-responding to an Initial 3 Day Course of Intravenous (IV) Methylprednisolone

What Was Tested

This registered phase 2, phase 3 trial tested ACTH (Corticotropin) for multiple sclerosis.

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.

It had two arms (groups): Methylprednisolone (active comparator) and ACTH (active comparator).

The registry classes the interventions as drug and other.

Who Took Part

30 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female. Females of childbearing potential must:. Have negative pregnancy tests prior to entry into the Double-blind Treatment Phase. Agree to use adequate contraception during the treatment. Females who are either post-menopausal for 12 months prior to randomization or surgically sterile (if documented), may be included without above requirements.

The full record lists 12 inclusion and 20 exclusion criteria; among the exclusions: a manifestation of ms other than relapsing; initial iv mp greater than 14 days after from start of presenting relapse; a history of chronic disease of the immune system other than ms or a known immunodeficiency syndrome.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The multiple sclerosis participants were allocated by chance, so the ACTH (Corticotropin) group and the comparison group should start out alike.

Groups ran in parallel: each of the multiple sclerosis participants stayed in one arm throughout.

Neither the multiple sclerosis participants nor the staff measuring them knew who was on ACTH (Corticotropin), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-10 with completion listed for 2011-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of ACTH (Corticotropin) in 30 people with multiple sclerosis.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the ACTH (Corticotropin) compound page, Multiple sclerosis research.