Effects of ACTHAR on Advanced MRI Surrogate Markers of Disease Activity and on Comprehensive Immune Signature During MS Relapses

What Was Tested

In this phase 4 trial, researchers set out to test ACTH (Corticotropin) for multiple sclerosis.

ACTHAR is a FDA approved drug for MS relapses.

Advanced serial MRI studies on patients during and after an acute MS relapse.

It had 1 arm (groups): Treated Group (experimental).

The registry classes the interventions as drug.

More on the Plan

Multiple sclerosis (MS) is a demyelinating disease of the CNS.

In a vast majority of patients, its clinical course is characterized by transient attacks of acute neurological compromise, followed by variable degree of recovery.

Each relapse leaves a patient with some degree of residual disability.

Hence, it is imperative that these relapses are optimally treated and curtailed in duration to allow for maximal recovery and repair.

Who Took Part

5 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: Age \> 18. Undergoing a clinical relapse and associated MRI active lesion.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: recent infection, any; use of any glucocorticoid 30 days prior to enrollment; unable to consent.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label ACTH (Corticotropin) study: the multiple sclerosis participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-12-20 with completion listed for 2020-10-07.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in T1 Lesion Relaxation Time (time frame: 12 month after the completion of intervention).

It also tracked 1 secondary outcome, for example Change in Immune Subset Expression in CD4+FOXP3 Tregs by Flow Cytometry Post ACTHAR Intervention.

What This Means in Plain Language

Put simply, this is a phase 4 trial of ACTH (Corticotropin) in 5 people with multiple sclerosis.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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