Effects of Acthar on Recovery From Cognitive Relapses in MS

What Was Tested

In this phase 3 trial, researchers set out to test ACTH (Corticotropin) for multiple sclerosis.

The purpose of this study is to evaluate the effect of a medication called Acthar on recovery from multiple sclerosis-related relapses that impact cognition.

It had two arms (groups): Cognitively Relapsing Patients (experimental) and Stable Multiple Sclerosis Patients (no intervention).

The registry classes the interventions as drug.

More on the Plan

This is a prospective, open-label study of Acthar administered as treatment for an acute cognitive relapse.

Primary and secondary endpoints will be collected prior to Acthar administration and at 3-month follow-up.

Comparison will be made to a stable MS control group.

The objectives of the study are: 1.

Who Took Part

The registry lists 64 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 a diagnosis of Relapsing Remitting MS (RRMS) or early Secondary Progressive MS (SPMS) as per revised McDonald's Criteria. Have an Expanded Disability Severity Scale (EDSS) of ≤ 7.0. Have had valid neuropsychological testing (NP) within the past 4 years. Are capable of performing the requirements of neuropsychological (NP) testing, including near visual acuity 20/70 or better with correction.

The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: are found to have evidence on mri of new lesions in the brainstem, spinal cord, or optic nerve; have clear new physical signs or symptoms that are referable to the cord, brainstem or optic nerve; have evidence of current major depression as determined by a positive beck depression inventory-fast screen (bdi-fs) and clinician interview.

How the Study Was Run

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

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 2013-08 with completion listed for 2018-11-01.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Change From Baseline on the Symbol Digit Modalities Test (SDMT) (time frame: Day 0 and Day 90). Timed 25-foot Walk (time frame: Day 0 and Day 90). Change From Baseline on the Paced Auditory Serial Addition Test (PASAT) (time frame: Day 0 and Day 90).

It also tracked 4 secondary outcomes, for example Change From Baseline on the Expanded Disability Status Scale (EDSS), Change From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ), Change From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS) and Change From Baseline on the Fatigue Severity Scale (FSS).

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of ACTH (Corticotropin) in 64 people with multiple sclerosis.

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.