A Trial of Neuroprotection With ACTH in Acute Optic Neuritis

What Was Tested

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

The researchers will compare the effect of ACTH and intravenous methylprednisolone therapy on axonal injury following ON using OCT, a sensitive, reproducible and noninvasive tool to measure RNFL thickness.

The primary outcome will be the average RNFL thickness at 6 months.

It had two arms (groups): Acthar Gel (ACTH) (experimental) and IV methylprednisolone (steroids) (active comparator).

15 days of intramuscular (IM) or sub-cutaneous corticotropin (SQ) Acthar (ACTH).

3 days of IV methylprednisolone (steroids) followed by 11 days of oral prednisone.

The registry classes the interventions as drug.

More on the Plan

Patients with their first episode of unilateral acute ON will be treated with either 3 days of IV methylprednisolone followed by 11 days of oral prednisone or 15 days of intramuscular or subcutaneous corticotropin (Acthar).

The primary, secondary, and tertiary outcomes will be as noted above.

The researchers expect to enroll up to 50 subjects per institution.

Study follow-up visits will subsequently occur at 1, 3, and 6 months.

Who Took Part

37 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: Ability to provide written informed consent before any study assessment is performed. Male and female patients aged between 18 and 55 years, inclusive. Diagnosis of clinically unilateral acute demyelinating optic neuritis (ADON). Clinical signs and symptoms of ADON starting within the 14 day prior to intended randomization (loss of vision, pain on movement, impairment of color vision). The qualifying episode of optic neuritis must be the first clinical episode of optic neuritis in the affected eye.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: bilateral optic neuritis; concurrent functionally or clinically relevant disturbances of the eye not affected by adon; non-assessable oct at screening.

How the Study Was Run

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

The multiple sclerosis participants were allocated by chance, so the ACTH (Corticotropin) group and the comparison group should start out alike.

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

Everyone knew when ACTH (Corticotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2013-05 with completion listed for 2022-01-13.

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

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Retinal Nerve Fiber Layer (RNFL) thickness (time frame: 6 months).

It also tracked 1 secondary outcome, for example Frequency of RNFL swelling.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in 37 people with multiple sclerosis.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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