ACTH in Progressive Forms of MS

What Was Tested

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

Patients will be randomly assigned to either an ACTH arm or a placebo arm.

It had two arms (groups): ACTH (experimental) and Placebo (placebo comparator).

ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month.

Placebo subcutaneous injections administered on 3 consecutive days per month.

The registry classes the interventions as drug.

Who Took Part

The registry lists 59 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Male or female patients with a confirmed diagnosis of MS by McDonald criteria. Age \>/= 18 years. SPMS, PPMS, or PRMS phenotype, according to Lublin and Reingold criteria. EDSS 2.0 - 6.0, inclusive. Able to understand the consent process.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: known intolerance of acth or corticosteroids; osteoporosis, defined as pre-existing diagnosis or t-score on dual-energy x-ray absorptiometry (dexa) scan of \</= -2.5; treatment with cytotoxic agents (including but not necessarily limited to mitoxantrone, cyclophosphamide, alemtuzumab, or rituximab) within 3 years prior to randomization.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got ACTH (Corticotropin) and who got the comparison, which limits bias.

Groups ran in parallel: each of the multiple sclerosis participants stayed in one arm throughout.

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, care provider, investigator and outcomes assessor.

It started in 2014-04-17 with completion listed for 2022-12-31.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 21 secondary outcomes, for example Safety and Tolerability of ACTH: Menstrual Changes [Female], Safety and Tolerability of ACTH: DEXA Scans, Safety and Tolerability of ACTH: Bruising, Safety and Tolerability of ACTH: Swelling Ankles, Safety and Tolerability of ACTH: Hair Loss and Safety and Tolerability of ACTH: Acne.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of ACTH (Corticotropin) in 59 people with multiple sclerosis.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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