Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)
Purpose
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).
Condition
- Multiple Sclerosis, Relapsing-Remitting
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Criteria
Key Inclusion Criteria:
- Had a clinical diagnosis of relapsing-remitting multiple sclerosis (RRMS)
- Had a relapse with onset ≤42 days prior to the Baseline Visit
- Had started treatment with 3 to 5 days (inclusive, over a period of up to 7 days) of
specific high dose corticosteroids within 28 days of the onset of the first relapse
symptom
- Had failed to obtain improvement of at least 1 point in one or more functions on the
Function Systems Score (FSS) 14 days following their first dose of high dose
corticosteroids
- Has an Expanded Disability Index Scale (EDSS) score of 2.0 to 6.5 (inclusive) at the
Baseline Visit
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- While Care Provider and Outcomes Assessor were also blinded, it was considered a double-blind study.
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Acthar Gel |
Participants receive Acthar Gel under the skin once a day for 14 consecutive days |
|
Placebo Comparator Placebo |
Participants receive Placebo under the skin once a day for 14 consecutive days |
|
More Details
- Status
- Terminated
- Sponsor
- Mallinckrodt ARD LLC