NCT03126760

Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)

A Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of Acthar® in Subjects With Relapsing-remitting Multiple Sclerosis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Mallinckrodt ARD LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will enroll about 66 participants who experienced a relapse of RRMS that steroids did not help. The doctor will put participants into a treatment group. Each person has an equal chance of being in either one of two groups (like flipping a coin). One group will receive a shot of study medicine (called Acthar Gel) under their skin every day for 14 days. The other group will receive a shot every day for 14 days, too, but there is no medicine in it (called placebo).

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DRUG	Acthar Gel	Acthar Gel 1 mL (80U) for subcutaneous injection
DRUG	Placebo	Placebo for subcutaneous injection

Timeline

• Start date: 2017-05-22
• Primary completion: 2020-07-14
• Completion: 2020-07-14
• First posted: 2017-04-24
• Last updated: 2021-07-12
• Results posted: 2021-06-03

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study