Pulse ACTH vs. MP for MS

What Was Tested

In this phase 1 trial, researchers set out to test ACTH (Corticotropin) for multiple sclerosis.

In addition, the researchers hypothesize that pulse therapy with ACTH alters immune function to favor a regulatory, rather than a pro-inflammatory T cell environment.

It had two arms (groups): ACTH IM monthly (experimental) and MP IV monthly (active comparator).

The registry classes the interventions as drug.

More on the Plan

Please see the final manuscript.

Who Took Part

23 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Clinically definite multiple sclerosis defined by McDonald Criteria. Between 18-65 years of age. Subjects who are women of childbearing potential, must have a negative serum pregnancy test at the screening visit, and must be willing to practice a reliable birth-control method. Subjects must have at least one MS relapse within last year and/or at least one new T2 or Gadolinium-enhanced lesion on MRI while on stable interferon therapy. EDSS (Expanded Disability Status Scale) score of 3.0 - 6.5.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: subject has a history of drug or alcohol abuse within the past year; subject had corticosteroid treatment within last 90 days; subject started new medication within last 30 days.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this ACTH (Corticotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The ACTH (Corticotropin) group and the comparison group ran side by side rather than switching.

Only one side, usually the multiple sclerosis participants, was kept unaware of whether ACTH (Corticotropin) was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2009-11 with completion listed for 2013-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Annualized Relapse Rate (time frame: 15 months study: 12 months treatment and 3 months follow up).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of ACTH (Corticotropin) in 23 people with multiple sclerosis.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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