Trial · NCT02290444
Effects of Acthar on Recovery From Cognitive Relapses in MS
NCT02290444, Phase 3, Completed, State University of New York at Buffalo; results first posted 2020-04-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Effects of Acthar on Recovery From Cognitive Relapses in MS. Trials, record NCT02290444. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02290444
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Acthar on Recovery From Cognitive Relapses in MS
- NCT number
- NCT02290444
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 64 participants, actual
- Lead sponsor
- State University of New York at Buffalo
- Conditions
- Multiple Sclerosis
- Interventions
- Adrenocorticotropic Hormone
- First posted
- 2014-11-14
- Last updated
- 2020-04-06
- Results first posted
- 2020-04-06
- Limitations and caveats
- Because of withdrawals and/or incomplete data, some enrolled subjects were excluded from the final data analysis.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline on the Symbol Digit Modalities Test (SDMT) | Day 0 and Day 90 | A measure of visual processing speed and working memory. Minimum score of 0, Maximum score of 120. Higher scores indicate better performance. The difference in total correct responses on the SDMT from Day 0 to Day 90 were analyzed to address change in this outcome. |
| Primary | Timed 25-foot Walk | Day 0 and Day 90 | An MS-specific measure of functional status walking speed. How many seconds does it take to walk 25 feet. Ceiling value of 300 seconds. |
| Primary | Change From Baseline on the Paced Auditory Serial Addition Test (PASAT) | Day 0 and Day 90 | A measure of auditory processing speed and working memory. Minimum value of 0, maximum value of 60. Higher score indicates better performance. The difference in total correct on the PASAT from Day 0 to Day 90 were analyzed to address change in this outcome. |
| Primary | Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R) | Day 0 and Day 90 | A measure of visual/spatial memory. Minimum of 0, maximum of 36. Higher score indicates better performance. The difference in total learning score on the BVMT-R from Day 0 to Day 90 were analyzed to address change in this outcome. |
| Primary | Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II) | Day 0 and Day 90 | A measure of auditory/verbal episodic memory. Minimum of 0, maximum of 80. Higher score indicates better performance. The difference in total learning score on the CVLT-II from Day 0 to Day 90 were analyzed to address change in this outcome. |
| Secondary | Change From Baseline on the Expanded Disability Status Scale (EDSS). | Day 0 and Day 90 | A clinician assigned measure of disability specific to MS. Minimum of 0 (no disability), maximum of 10 (death due to MS). Higher scores indicate greater disability. The difference in total score on the EDSS from Day 0 to Day 90 were analyzed to address change in this outcome. |
| Secondary | Change From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) | Day 0 and Day 90 | A self and informant rating measure of perceived cognitive problems. Minimum of 0, maximum of 60. Higher scores indicates greater self-reported neuropsychological impairment. The difference in total score on the MSNQ from Day 0 to Day 90 were analyzed to address change in this outcome. |
| Secondary | Change From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS) | Day 0 and Day 90 | A self-report, multiple choice inventory of depression. Minimum of 0, maximum of 21. Higher score indicates higher levels of depression. The difference in total score on the BDI-FS from Day 0 to Day 90 were analyzed to address change in this outcome. |
| Secondary | Change From Baseline on the Fatigue Severity Scale (FSS) | Day 0 and Day 90 | A self-report measure of fatigue. 1 (no fatigue) to 9 (severe fatigue). The difference in total score on FSS from Day 0 to Day 90 were analyzed to address change in this outcome. |
| Other | Incidence of Adverse Events | Up to 3 months | The number of patients reporting adverse events over the course of the study |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline on the Symbol Digit Modalities Test (SDMT) | Day 0 and Day 90 | The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics. | Total Correct | MEAN |
| PRIMARY | Timed 25-foot Walk | Day 0 and Day 90 | The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics. | Seconds | MEAN |
| PRIMARY | Change From Baseline on the Paced Auditory Serial Addition Test (PASAT) | Day 0 and Day 90 | The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics. | Total Correct | MEAN |
| PRIMARY | Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R) | Day 0 and Day 90 | The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics. | Total Learning Score | MEAN |
| PRIMARY | Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II) | Day 0 and Day 90 | The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics. | Total Learning Score | MEAN |
| SECONDARY | Change From Baseline on the Expanded Disability Status Scale (EDSS). | Day 0 and Day 90 | The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics. | Total Score | MEDIAN |
| SECONDARY | Change From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) | Day 0 and Day 90 | The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics. | Total Score | MEAN |
| SECONDARY | Change From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS) | Day 0 and Day 90 | Total Score | MEAN | |
| SECONDARY | Change From Baseline on the Fatigue Severity Scale (FSS) | Day 0 and Day 90 | The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics. | Total Score | MEAN |
| OTHER_PRE_SPECIFIED | Incidence of Adverse Events | Up to 3 months |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline on the Symbol Digit Modalities Test (SDMT) | Cognitively Relapsing Patients | 44.6 | Standard Deviation 13.9 | Total Correct | |
| Change From Baseline on the Symbol Digit Modalities Test (SDMT) | Stable Multiple Sclerosis Patients | 58.5 | Standard Deviation 13.9 | Total Correct | |
| Timed 25-foot Walk | Cognitively Relapsing Patients | 6.7 | Standard Deviation 3.2 | Seconds | |
| Timed 25-foot Walk | Stable Multiple Sclerosis Patients | 5.3 | Standard Deviation 1.2 | Seconds | |
| Change From Baseline on the Paced Auditory Serial Addition Test (PASAT) | Cognitively Relapsing Patients | 40.1 | Standard Deviation 12.2 | Total Correct | |
| Change From Baseline on the Paced Auditory Serial Addition Test (PASAT) | Stable Multiple Sclerosis Patients | 47.0 | Standard Deviation 14.3 | Total Correct | |
| Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R) | Cognitively Relapsing Patients | 22.0 | Standard Deviation 8.9 | Total Learning Score | |
| Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R) | Stable Multiple Sclerosis Patients | 22.5 | Standard Deviation 7.9 | Total Learning Score | |
| Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II) | Cognitively Relapsing Patients | 46.6 | Standard Deviation 14.1 | Total Learning Score | |
| Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II) | Stable Multiple Sclerosis Patients | 51.2 | Standard Deviation 11.8 | Total Learning Score |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cognitively Relapsing Patients | 30 | |
| Overall Study | STARTED | Stable Multiple Sclerosis Patients | 34 | |
| Overall Study | COMPLETED | Cognitively Relapsing Patients | 29 | |
| Overall Study | COMPLETED | Stable Multiple Sclerosis Patients | 32 | |
| Overall Study | NOT COMPLETED | Cognitively Relapsing Patients | 1 | |
| Overall Study | NOT COMPLETED | Stable Multiple Sclerosis Patients | 2 |
Source ClinicalTrials.gov
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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cognitively Relapsing Patients | 0 | 25 |
| Total, all-cause mortality | Stable Multiple Sclerosis Patients | 0 | 25 |
| Total, other adverse events | Cognitively Relapsing Patients | 0 | 25 |
| Total, other adverse events | Stable Multiple Sclerosis Patients | 0 | 25 |
| Total, serious adverse events | Cognitively Relapsing Patients | 0 | 25 |
| Total, serious adverse events | Stable Multiple Sclerosis Patients | 0 | 25 |
Source ClinicalTrials.gov
Papers24
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Cognitively Relapsing Patients vs Stable Multiple Sclerosis Patients: deaths from any cause | Trial comparisons |
| Cognitively Relapsing Patients vs Stable Multiple Sclerosis Patients: serious adverse events | Trial comparisons |
Tests3
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 | Source |
|---|---|---|
| Paced Visual Serial Addition Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | 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/NCT02290444
GET https://conductscience.org/api/trials/v1/NCT02290444/papers?page=2