Tolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS)

What Was Tested

In this not phased trial, researchers set out to test ACTH (Corticotropin) for multiple sclerosis.

Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS).

It had 1 arm (groups): Single arm (experimental).

The registry classes the interventions as drug.

More on the Plan

The researchers propose to conduct a prospective, single-center, open-label, single-arm study comparing tolerability of Acthar versus oral prednisone in the treatment of MS relapses.

Potential subjects will be identified during routine clinical evaluations.

If patient is determined to be having a study-defined MS relapse, they will be invited to participate in this study.

After consent is obtained, the patient will complete the first page of the ARMS survey.

Who Took Part

The registry lists 30 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Subjects who have volunteered and consented to participate in the study. Male or Female subjects age 18 or greater years of age. Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) based on 2010 McDonald Criteria. Subjects without an active infection (Note: If a patient is found to have an uncomplicated UTI and agrees to start on appropriate antibiotic treatment, they can continue in the study). Subjects who are experiencing a protocol defined MS relapse within two weeks of relapse onset.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: subjects who are less than 18 years of age; subjects with any contraindication to taking acthar; subjects with an immune deficiency.

How the Study Was Run

The set-up was single-group and open-label.

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 2014-06 with completion listed for 2016-06-24.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: ARMS (Assessing Relapses in Multiple Sclerosis) ADL Scores (Activities of Daily Living) (time frame: baseline visit & follow-up after treatment). ARMS (Assessing Relapses in Multiple Sclerosis) RSH Scores (Return to Previous Health) (time frame: baseline visit & follow-up after treatment). ARMS (Assessing Relapses in Multiple Sclerosis) TCS Scores (Total Composite Scores) (time frame: Follow-up visit).

It also tracked 1 secondary outcome, for example GASE Scale Questionnaire (Generic Assessment of Side Effects).

What This Means in Plain Language

Put simply, this is a not phased 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.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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