Evaluation of the Response to Acthar Gel Therapy in Patients Who Failed Intravenous Methylprednisolone (IVMP) for MS Relapses

Plain-language guide to NCT01900093: not phased interventional trial of ACTH (Corticotropin), multiple sclerosis, 10 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01900093
Phase: not phased
Status: status unknown
Start: 2013-07
Completion (planned or actual): 2018-03
Participants: 10 (estimated)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Multiple Sclerosis
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

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

Although ACTHAR gel is approved for the treatment of acute relapses, it is currently not widely used.

Documentation of the clinical course as well as any adverse events related to IVMP use will be made.

It had 1 arm (groups): Acthar Gel (experimental).

The registry classes the interventions as drug.

More on the Plan

Patients will be evaluated at baseline, at 1 week of Acthar treatment, at completion of Acthar treatment, and 1 week after completion of treatment.

For those who do not undergo plasmapheresis an additional evaluation will be conducted 2 weeks after completion of treatment.

Monitoring will include blood pressure determination and blood sugar determination.

Who Took Part

10 planned participants were the target.

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: EDSS of 2.0 - 7.5 (inclusive). Must be able to comply with the requirements of the protocol as determined by the investigator.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: patients whose relapse consists of pure sensory or bowel/bladder symptoms; recent history of drug or alcohol abuse; concomitant use or prior use in the preceding 6 months of any investigational drug.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the ACTH (Corticotropin) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-07 with completion listed for 2018-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a not phased trial of ACTH (Corticotropin) in 10 people with multiple sclerosis.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

ACTH (Corticotropin): The 39-amino-acid pituitary hormone that drives cortisol production; given as repository corticotropin (Acthar Gel).

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.