Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)

What Was Tested

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

This study will enroll about 66 participants who experienced a relapse of RRMS that steroids did not help.

The doctor will put participants into a treatment group.

Each person has an equal chance of being in either one of two groups (like flipping a coin).

It had two arms (groups): Acthar Gel (experimental) and Placebo (placebo comparator).

Participants receive Acthar Gel under the skin once a day for 14 consecutive days.

Participants receive Placebo under the skin once a day for 14 consecutive days.

The registry classes the interventions as drug.

Who Took Part

35 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: Had a clinical diagnosis of relapsing-remitting multiple sclerosis (RRMS). Had a relapse with onset ≤42 days prior to the Baseline Visit. Has an Expanded Disability Index Scale (EDSS) score of 2.0 to 6.5 (inclusive) at the Baseline Visit.

The full record lists 5 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and double-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.

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 and investigator.

It started in 2017-05-22 with completion listed for 2020-07-14.

It ran at 22 sites in United States (22).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42 (time frame: Baseline, Day 42).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in 35 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.