OPTIONS
What it found
The trial was stopped early for safety reasons.
Reason given: Recruitment difficulties and COVID-19 logistical challenges; no safety concerns
What was tested
Treatment tested
- Corticotropin
Melanocortin receptor 2 agonist
Placebo or sham
- Placebo
Results by group
Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42
Baseline, Day 42
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Acthar Gel | 3.86 score on a scale | 1.122 (Standard Deviation) | 18 |
| Placebo | 3.85 score on a scale | 1.169 (Standard Deviation) | 17 |
| Acthar Gel | 2.92 score on a scale | 0.974 (Standard Deviation) | 18 |
| Placebo | 3.62 score on a scale | 1.485 (Standard Deviation) | 17 |
Acthar Gel
Placebo
Acthar Gel
Placebo
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Acthar Gel | 18 | 0 (0.0%) | 0 |
| Placebo | 17 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42
Baseline, Day 42
Disability progression
Who could take part
Relapsing MS · 18 and over
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Loading reviews and guidelines…
Related trials
- IN-DXM-EMRR
Phase 2 · Enrolling by invitation
Still running
- Corticosteroid Effects on Asymptomatic Gadolinium-enhanci…
Phase 2 · Completed
No result found
- MUSETTE
Phase 3 · Running, not recruiting
Missed its main goal
- NTZ2TTY
Phase 4 · Status unknown
No result found
- INCREASE
Phase 2 · Stopped early
Stopped early
- MOST
Phase 3 · Stopped early
Stopped early
History
Started
May 2017
Main results due
Jul 2020
Finished
Jul 2020
Results posted
Jun 2021
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error