Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS

What Was Tested

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

The main secondary objective is to utilize every three month MWF measurements to determine the peak time of remyelination in new multiple sclerosis lesions when followed over the course of 12 months.

It had two arms (groups): One Time Treatment (active comparator) and Monthly Treatments (experimental).

The registry classes the interventions as drug.

More on the Plan

This pilot study proposal is designed to perform a chronological measurement of MWF in new contrast-enhancing lesions in subjects treated with ACTH during an acute exacerbation of MS.

The initial course of ACTH (H.P.

The Judith Jaffe Multiple Sclerosis Center currently has over 1000 subjects in a clinical and MRI database.

The subjects who have signed consent for the database will have their standard of care MRI scans monitored for new enhancing lesions; this will only have to be repeated if initial scan is not completed at their MS center with their current clinical protocol.

Who Took Part

15 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: Patients with RRMS or SPMS with new contrast-enhancing lesions who will start as part of their standard of care ACTH.

The full record lists 1 inclusion and 15 exclusion criteria; among the exclusions: patients with known or new allergy to acth; patients being treated with natalizumab, rituximab, and cyclophosphamide; patients unwilling to have serial mri exams.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got ACTH (Corticotropin) and who got the comparison, which limits bias.

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

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

It started in 2016-06 with completion listed for 2020-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Myelin Water Fraction (MWF) Within New Enhancing Lesions Over the Course of 12 Months (time frame: Baseline, 12 months).

It also tracked 5 secondary outcomes, for example Physical Disability as Measured by EDSS, Change in T2 Lesion Volume, Cortical Volume, Whole Brain Volume and Longitudinal Assessment of MWF.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in 15 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.