Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS)

What Was Tested

The trial (phase 2) is built around ACTH (Corticotropin) for multiple sclerosis.

It had two arms (groups): Adrenocorticotropin hormone (active comparator) and Placebo (placebo comparator).

Patients receive the hormone.

Patients receive placebo only.

The registry classes the interventions as drug.

More on the Plan

Multiple sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system (CNS).

It is a complex, multi-factorial disease that includes inflammatory and neurodegenerative processes manifesting both focally in the form of lesions and diffusely in otherwise normal-appearing brain tissue.

Adding a regimen of ACTH to standard Avonex treatment may provide neuroprotection and promote remyelination.

Who 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: Patient diagnosed with MS according to McDonald criteria. Have a RR disease course. Have EDSS scores 0-5.5. Have a disease duration \<20 years. Sub-optimal response to Interferon beta-1a I.M. (Avonex®) while being on therapy for at least 6 months defined as:.

The full record lists 11 inclusion and 7 exclusion criteria; among the exclusions: presence of relapse or steroid treatment within 60 days prior to study enrollment; presence of neutralizing antibodies to ifnβ-1a i.m. prior to study enrollment; presence of optic neuritis within less than 6 months prior to study enrollment.

How the Study Was Run

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

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.

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 care provider.

It started in 2009-12 with completion listed for 2010-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. on a voxel-wise MTR dynamic mapping of the lesions and NABT in patients with RRMS (time frame: 1 year).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of ACTH (Corticotropin) in people with multiple sclerosis.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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