Pilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ)Versus ACTHar Gel Five Days SQ for the Treatment of MS Exacerbations

What Was Tested

This registered phase 4 trial tested ACTH (Corticotropin) for multiple sclerosis.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Evaluations and treatment will be administered as an outpatient in the Neurology Clinic.

Each subject will be seen for MS relapse or exacerbation in the Neurology Clinic during a routine or semi-emergent visit.

Both protocols are within package insert guidelines.

The subjects will be evaluated for Extended Disability Status Scales (EDSS), a standardized measure of clinical status in MS and the initial visit and 28 days later (and 90 days later).

Who Took Part

The registry lists 25 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosis of a relapsing forms of multiple sclerosis before randomization as determined by Poser or McDonald Criteria (standard MS diagnostic criteria). Expanded disability status scale (EDDS) between 2 and 6.5, inclusive at entry. Episodes include study neurologist or neuro-ophthalmologist diagnosed: acute optic neuritis, cerebellar, brainstem dysfunction, myelitis, focal cerebral, and/or definitive focal sensory dysfunction. New objective clinical finding other than the sensory exacerbation or the bowel/bladder signs alone. Sensory deficits alone will not qualify except for optic neuritis. Subjects may continue on their current immunomodulation therapy such as interferons, glatiramer acetate, gilenya or natalizumab.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: subjects who are pregnant, or nursing; any patients treated with systemic corticosteroid use within one month of the index episode at screening; prior use of immunosuppressive treatments within 90 days of index episode (mitoxantrone, azathioprine, cellcept, ivig) or plasmapheresis.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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.

Blinding on both sides kept the multiple sclerosis participants and researchers unaware of who received ACTH (Corticotropin).

Those kept unaware of assignments: participant and investigator.

It started in 2013-04 with completion listed for 2014-08.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Comparison of EDSS Mean Recovery between 5-day vs 14-day SQ [amount hidden] ACTHar Gel therapy groups.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in 25 people with multiple sclerosis.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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