Trial · NCT03126760
Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)
NCT03126760, Phase 4, Terminated, Mallinckrodt ARD LLC; results first posted 2021-06-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS). Trials, record NCT03126760. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03126760
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)
- NCT number
- NCT03126760
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 35 participants, actual
- Lead sponsor
- Mallinckrodt ARD LLC
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- Acthar Gel, Placebo
- First posted
- 2017-04-24
- Last updated
- 2021-07-12
- Results first posted
- 2021-06-03
- Limitations and caveats
The study was terminated early by sponsor decision because of recruitment difficulties and the impact of the COVID-19 pandemic. The planned analyses did not change except that the total sample size was reduced. Inferential statistics were not performed. Results are nominal because the sample size did not reach that specified in the protocol.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42 | Baseline, Day 42 | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42 | Baseline, Day 42 | modified Intent to Treat (mITT) | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42 | Acthar Gel | Baseline | 3.86 | Standard Deviation 1.122 | score on a scale |
| Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42 | Placebo | Baseline | 3.85 | Standard Deviation 1.169 | score on a scale |
| Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42 | Acthar Gel | Day 42 | 2.92 | Standard Deviation 0.974 | score on a scale |
| Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42 | Placebo | Day 42 | 3.62 | Standard Deviation 1.485 | score on a scale |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acthar Gel | 18 | |
| Overall Study | STARTED | Placebo | 17 | |
| Overall Study | Modified Intent to Treat (mITT) | Acthar Gel | 18 | |
| Overall Study | Modified Intent to Treat (mITT) | Placebo | 17 | |
| Overall Study | Completed Treatment | Acthar Gel | 17 | |
| Overall Study | Completed Treatment | Placebo | 17 | |
| Overall Study | COMPLETED | Acthar Gel | 18 | |
| Overall Study | COMPLETED | Placebo | 17 | |
| Overall Study | NOT COMPLETED | Acthar Gel | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events118
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Goitre | Endocrine disorders | Acthar Gel | 0 | 18 | |
| other | Goitre | Endocrine disorders | Placebo | 1 | 17 | |
| other | Corneal degeneration | Eye disorders | Acthar Gel | 0 | 18 | |
| other | Corneal degeneration | Eye disorders | Placebo | 1 | 17 | |
| other | Vision blurred | Eye disorders | Acthar Gel | 0 | 18 | |
| other | Vision blurred | Eye disorders | Placebo | 1 | 17 | |
| other | Dyspepsia | Gastrointestinal disorders | Acthar Gel | 0 | 18 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 1 | 17 | |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Acthar Gel | 0 | 18 | |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Placebo | 1 | 17 |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acthar Gel | 0 | 18 |
| Total, all-cause mortality | Placebo | 0 | 17 |
| Total, other adverse events | Acthar Gel | 14 | 18 |
| Total, other adverse events | Placebo | 12 | 17 |
| Total, serious adverse events | Acthar Gel | 0 | 18 |
| Total, serious adverse events | Placebo | 0 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Acthar Gel vs Placebo: deaths from any cause | Trial comparisons |
| Acthar Gel vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03126760
GET https://conductscience.org/api/trials/v1/NCT03126760/events?page=2