Trial · NCT01888354
Pilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ)Versus ACTHar Gel Five Days SQ for the Treatment of MS Exacerbations
NCT01888354, Phase 4, Completed, The University of Texas Health Science Center, Houston
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ)Versus ACTHar Gel Five Days SQ for the Treatment of MS Exacerbations. Trials, record NCT01888354. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01888354
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ)Versus ACTHar Gel Five Days SQ for the Treatment of MS Exacerbations
- NCT number
- NCT01888354
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 25 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Multiple Sclerosis (MS)
- Interventions
- H.P. Acthar Gel (repository corticotropin injection)
- First posted
- 2013-06-27
- Last updated
- 2014-09-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison of EDSS Mean Recovery between 5-day vs 14-day SQ 80 IU ACTHar Gel therapy groups | 28 Days (with 90 day follow-up) | To determine whether a standard 14 day course of SQ 80 IU ACTHar Gel therapy might be superior (in twice as many patients) to treatment with 5 day SQ regimen for ACTHar Gel as determined by EDSS mean recovery from Day 0 (time of steroid therapy initiation) to Day 28 (and day 90). |
| Secondary | Comparison of ambulation between the 5-day vs.14-day SQ 80 IU ACTHar Gel therapy groups | 28 Days (with 90 day follow-up) | The ambulation index (AI) will be used for patients with long track (pyramidal) relapses, i.e. relapses with leg involvement. This is a standardized rating scale developed to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. |
| Secondary | Comparison of upper extremity function between the 5-day vs.14-day SQ 80 IU ACTHar Gel therapy groups | 28 day (with 90 follow up) | The nine-hole peg test (9HPT) will be used for patients with arm involvement during relapses. The 9-HPT is a brief, standardized, quantitative test of upper extremity function. This is a timed test to determine how long it takes the patient to quickly place nine pegs (one at a time) in a wooden box with 9 empty holes, and them remove them again (one at a time) as quickly as possible. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. |
| Secondary | Comparison of subjective impressions of effectiveness between the 5-day vs 14-day SQ 80 IU ACTHar Gel therapy groups | 28 day (with 90 day follow up) | The patient global impression of change (PGI-Change) will be used in patients to compare subjective impressions of effectiveness between treatment groups |
| Secondary | Compare visual function between 5-day vs 14-day SQ 80 IU ACTHar Gel therapy groups | 28 day (with 90 day follow up) | Visual function, as measured by low contrast Sloan sensitivity testing (LCSST) will be performed on each patient at baseline and at the end of treatment |
| Secondary | Comparison of cognitive function between the 5-day vs 14-day SQ 80 IU ACTHar Gel therapy groups | 28 day (with 90 day follow up) | In patients who report cognitive deficits during relapse, the paced auditory serial addition test (PASAT-3) will be used to assess and measure capacity and rate of information processing, and sustained and divided attention. This is a common neuropsychological test used in MS trials that involves working memory, attention and arithmetic capabilities. Patients will hear a series of recorded single-digit numbers at a rate of 1 per 3 seconds, and asked to add the number they just heard with the number they heard before. |
| Other | Comparison of MRI brain activity before and after ACTH treatment between the two treatment groups | 28 Days (with 90 day follow-up) | Brain MRI scan ± Gd will be performed on subjects at entry, day 28 and day 90. Qualitative assessments of changes in numbers of Gd+ lesions from entry to exit will be assessed. |
| Other | Comparison of immune changes before and after ACTH treatment between the two treatment groups | 28 Days (with 90 day follow-up) | Peripheral mononuclear cells will be collected from patients at baseline,14 and 28 days post treatment and cytokine responses will be examined using a customized Human Cytokine Inflammatory Antibody Array including Th1-like (IL-2, IL-17, IFN-g, TNF-a, IL-1b), Th2-like cytokines (IL-4, IL-10, IL-13) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Paced Visual Serial Addition Test | Secondary outcome |
Source ConductCognition
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/NCT01888354
GET https://conductscience.org/api/trials/v1/NCT01888354/registered