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

NCT03126760 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-07-12

Study results available
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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

DRUG

Acthar Gel

Acthar Gel 1 mL (80U) for subcutaneous injection

DRUG

Placebo

Placebo for subcutaneous injection

Sponsors & Collaborators

  • Mallinckrodt ARD LLC

    lead INDUSTRY

Principal Investigators

  • Clinical Team Leader · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2020-07-14
Completion
2020-07-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03126760 on ClinicalTrials.gov