ACTH in Progressive Forms of MS

Summary

This is a phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of adrenocorticotropic hormone (ACTH, Acthar gel) administered as a pulsed regimen consisting of injections on three consecutive days per month in patients with progressive forms of Multiple Sclerosis (MS). Patients will be randomly assigned to either an ACTH arm or a placebo arm. The main hypotheses are that 1) pulsed ACTH will be safe and well-tolerated, and 2) pulsed ACTH will slow progression of clinical and paraclinical measures of MS progression compared to placebo.

Timeline

Start

2014-04-17

Primary completion

2022-12-31

Completion

2022-12-31

Outcome

Outcome not reported

Stopped (Business): “The funding source discontinued financial support for the study.”

Drugs

Indications