ACTH for Fatigue in Multiple Sclerosis Patients

What Was Tested

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

This is a study of Acthar gel (ACTH) in patients with relapsing multiple sclerosis who are experiencing chronic fatigue.

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

Placebo will be given subcutaneously twice weekly for 28 weeks.

The registry classes the interventions as drug.

More on the Plan

Secondary objectives include assessment of the tolerability and safety of twice-weekly ACTH treatment vs. placebo and evaluation of ACTH on depression, sleepiness, and quality of life measures and correlations between these measures.

Who Took Part

8 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: Have documented diagnosis of Relapsing MS as defined by McDonald Criteria 2011 Revision for at least 6 months. Have an Kurtzke Expanded Disability Status Scale (EDSS) score of 0 to 4, inclusive. Able to understand the purpose and risks of the study. Must be willing to sign an inform consent. Must be willing to follow the protocol requirements.

The full record lists 9 inclusion and 17 exclusion criteria; among the exclusions: have any of the contraindications for acthar gel as listed in the approved label, including sensitivity to proteins of porcine origin; had treatment of systemic or oral corticosteroids of any type in 90 days prior to baseline/randomization; had a relapse or documented objective neurologic worsening in 90 days prior to baseline/randomization.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

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, care provider and investigator.

It started in 2015-05-22 with completion listed for 2017-06-20.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Fatigue at 28 Weeks (time frame: 28 weeks).

It also tracked 3 secondary outcomes, for example Depression at 28 Weeks, Sleepiness at 28 Weeks and Quality of Life at 28 Weeks.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of ACTH (Corticotropin) in 8 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.