Trial · Interventional

TerminatedPhase 4Results postedRegistry data

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

Short name OPTIONS

NCTNCT03126760Other idMNK14274069

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Recruitment difficulties and COVID-19 logistical challenges; no safety concerns

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 35 participants (actual)
Sponsor: Mallinckrodt ARD LLC · Industry
Design: Randomized · Double masking
Countries: 1 country
United States
Start: 22 May 2017
Primary completion: 14 Jul 2020
Completion: 14 Jul 2020
First posted: 24 Apr 2017
Last update posted: 12 Jul 2021
Conditions: Multiple Sclerosis, Relapsing-Remitting

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20172018201920202021

Ph 4
OPTIONS
NCT03126760
22 May 2017 to 14 Jul 2020
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

Acthar GelDrug
PlaceboDrug

Arms2

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42
Time frame · Baseline, Day 42
Registry description
The EDSS is a 10-point assessment of neurological impairment/disability in multiple sclerosis (MS) patients, ranging from 0 (normal neurological examination) to 10 (death due to MS). EDSS is rated by a person who only collects outcome measures, and has no knowledge of the treatment received.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline, Day 42

Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42

Group	Value (score on a scale)	Spread
Acthar Gel	3.86	1.122
Placebo	3.85	1.169

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Acthar GelParticipants receive Acthar Gel under the skin once a day for 14 consecutive days	0 / 18	0 / 18	14 / 18
PlaceboParticipants receive Placebo under the skin once a day for 14 consecutive days	0 / 17	0 / 17	12 / 17

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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