NCT02315872

ACTH for Fatigue in Multiple Sclerosis Patients

The Effect of ACTH (Acthar) on Measures of Chronic Fatigue in Patients With Relapsing Multiple Sclerosis.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a study of Acthar gel (ACTH) in patients with relapsing multiple sclerosis who are experiencing chronic fatigue.

Detailed description

This is a multi-center, randomized, double-blind, placebo-controlled study to demonstrate the safety, tolerability, and effect of ACTH on fatigue in patients with relapsing multiple sclerosis (RMS). The primary objective of this study is to assess the efficacy of ACTH versus placebo in reducing fatigability in patients with RMS. Secondary objectives include assessment of the tolerability and safety of twice-weekly ACTH treatment vs. placebo and evaluation of ACTH on depression, sleepiness, and quality of life measures and correlations between these measures.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DRUG	ACTH	ACTH injections twice weekly for 28 weeks.
DRUG	Placebo	Placebo injections twice weekly for 28 weeks.

Timeline

• Start date: 2015-05-22
• Primary completion: 2017-06-20
• Completion: 2018-12-13
• First posted: 2014-12-12
• Last updated: 2019-09-09
• Results posted: 2019-08-13

Locations

5 sites across 1 country: United States