Trial · NCT02446886
Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS
NCT02446886, Phase 4, Terminated, Weill Medical College of Cornell University; results first posted 2021-01-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS. Trials, record NCT02446886. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02446886
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS
- NCT number
- NCT02446886
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 15 participants, actual
- Lead sponsor
- Weill Medical College of Cornell University
- Conditions
- Multiple Sclerosis
- Interventions
- Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®)
- First posted
- 2015-05-18
- Last updated
- 2021-01-22
- Results first posted
- 2021-01-22
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Myelin Water Fraction (MWF) Within New Enhancing Lesions Over the Course of 12 Months | Baseline, 12 months | Primary outcome: The absolute change in lesion MWF (over our test-retest variability) between baseline and one year MRI's will be calculated and compared between treatment groups. Method to assess lesion MWF: FAST-T2 is a multi-compartment T2 relaxometry MRI technique wherein the contribution of water associated with myelin and other tissue compartments is differentiated using T2 decay curve analysis. The relative contribution of the myelin water with respect to total water is represented as MWF. A higher MWF within a lesion reflects higher myelin content within that lesion. For this analysis, MWF maps were reconstructed from FAST-T2 MRI data by using a multi-voxel nonlinear least-squares data-fitting algorithm with spatial smoothness constraints. MWF was calculated as the ratio of the myelin water signal to the total water signal within a voxel. Lesion MWF is an average of the voxels present within an individual lesion. |
| Secondary | Physical Disability as Measured by EDSS | 12 months | Expanded Disability Status Scale (EDSS) 0 Normal neurological exam, no disability in any FS 1.0 No disability, minimal signs in one FS 1.5 No disability, minimal signs in more than one FS 2.0 Minimal disability in one FS 2.5 Mild disability in one FS or minimal disability in two FS 3.0 Moderate disability in one FS, or mild disability in three or four FS. No impairment to walking 3.5 Moderate disability in one FS and more than minimal disability in several others. No impairment to walking 4.0 Significant disability but self-sufficient and up and about some 12 hours a day. Able to walk without aid or rest for 500m 4.5 Significant disability but up and about much of the day, able to work a full day, may otherwise have some limitation of full activity or require minimal assistance. Able to walk without aid or rest for 300m 10.0 Death due to MS A higher score means a worse outcome. |
| Secondary | Change in T2 Lesion Volume | 12 months | The change in T2 lesion volume between baseline and one year MRI's will be calculated and compared between treatment groups. |
| Secondary | Cortical Volume | 12 Months | Change in cortical volume of the brain over 12 months. |
| Secondary | Whole Brain Volume | 12 months | Change in whole brain volume over 12 months. |
| Secondary | Longitudinal Assessment of MWF | 12 months | Outcome measure: Longitudinal assessment of MWF (every 3 months) to determine the dynamics of myelin change over 12 months. Method to assess lesion MWF: FAST-T2 is a multi-compartment T2 relaxometry MRI technique wherein the contribution of water associated with myelin and other tissue compartments is differentiated using T2 decay curve analysis. The relative contribution of the myelin water with respect to total water is represented as MWF. A higher MWF within a lesion reflects higher myelin content within that lesion. For this analysis, MWF maps were reconstructed from FAST-T2 MRI data by using a multi-voxel nonlinear least-squares data-fitting algorithm with spatial smoothness constraints. MWF was calculated as the ratio of the myelin water signal to the total water signal within a voxel. Lesion MWF is an average of the voxels present within an individual lesion. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Myelin Water Fraction (MWF) Within New Enhancing Lesions Over the Course of 12 Months | Baseline, 12 months | myelin water fraction | MEAN | |
| SECONDARY | Physical Disability as Measured by EDSS | 12 months | score on a scale | MEAN | |
| SECONDARY | Change in T2 Lesion Volume | 12 months | millimeters cubed | MEAN | |
| SECONDARY | Cortical Volume | 12 Months | Data was not collected due to patient withdrawal. Too small of a sample size. | ||
| SECONDARY | Whole Brain Volume | 12 months | Data was not collected due to patient withdrawal. Too small of a sample size. | ||
| SECONDARY | Longitudinal Assessment of MWF | 12 months | myelin water fraction | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Myelin Water Fraction (MWF) Within New Enhancing Lesions Over the Course of 12 Months | One Time Treatment | 1.7 | Standard Deviation 1.8 | myelin water fraction | |
| Change in Myelin Water Fraction (MWF) Within New Enhancing Lesions Over the Course of 12 Months | Monthly Treatments | -0.20 | Standard Deviation 1.3 | myelin water fraction | |
| Physical Disability as Measured by EDSS | One Time Treatment | .5 | Standard Deviation .9 | score on a scale | |
| Physical Disability as Measured by EDSS | Monthly Treatments | 1.1 | Standard Deviation 1.5 | score on a scale | |
| Change in T2 Lesion Volume | One Time Treatment | 683.59 | Standard Deviation 1241.92 | millimeters cubed | |
| Change in T2 Lesion Volume | Monthly Treatments | 1092.08 | Standard Deviation 1513.45 | millimeters cubed | |
| Longitudinal Assessment of MWF | One Time Treatment | 1.7 | Standard Deviation 1.8 | myelin water fraction | |
| Longitudinal Assessment of MWF | Monthly Treatments | -.2 | Standard Deviation 1.3 | myelin water fraction |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | One Time Treatment | 8 | |
| Overall Study | STARTED | Monthly Treatments | 7 | |
| Overall Study | COMPLETED | One Time Treatment | 6 | |
| Overall Study | COMPLETED | Monthly Treatments | 3 | |
| Overall Study | NOT COMPLETED | One Time Treatment | 2 | |
| Overall Study | NOT COMPLETED | Monthly Treatments | 4 |
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 | One Time Treatment | 0 | 8 |
| Total, all-cause mortality | Monthly Treatments | 0 | 7 |
| Total, other adverse events | One Time Treatment | 0 | 8 |
| Total, other adverse events | Monthly Treatments | 0 | 7 |
| Total, serious adverse events | One Time Treatment | 0 | 8 |
| Total, serious adverse events | Monthly Treatments | 0 | 7 |
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 |
|---|---|
| One Time Treatment vs Monthly Treatments: deaths from any cause | Trial comparisons |
| One Time Treatment vs Monthly Treatments: 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/NCT02446886
GET https://conductscience.org/api/trials/v1/NCT02446886/registered