Trial · NCT01950234
ACTH in Progressive Forms of MS
NCT01950234, Phase 2, Terminated, University of Minnesota; results first posted 2025-02-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ACTH in Progressive Forms of MS. Trials, record NCT01950234. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01950234
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ACTH in Progressive Forms of MS
- NCT number
- NCT01950234
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 59 participants, actual
- Lead sponsor
- University of Minnesota
- Conditions
- Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Progressive Relapsing Multiple Sclerosis
- Interventions
- ACTH, Placebo
- First posted
- 2013-09-25
- Last updated
- 2025-02-11
- Results first posted
- 2025-02-11
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients Exhibiting a 20% Worsening in T25FW at 36 Months | Month 36 | |
| Secondary | Safety and Tolerability of ACTH: Menstrual Changes [Female] | Month 36 | Count of participants self reporting at any time throuhgout the study noticing any changes in menstrual cycle or period. |
| Secondary | Safety and Tolerability of ACTH: DEXA Scans | Month 36 | The number is a T-score. There is no maximum or minimum value. Mean change in average of 5 DEXA scan values dual-energy x-ray absorptiometry; measures bone mineral density. Higher numbers are better. A DEXA T-score has a mean of 0 and standard deviation of 1, meaning that a T-score represents how many standard deviations a person's bone density is away from the average bone density of a healthy young adult, with a score of 0 indicating average bone density. Higher scores are better, indicating better bone density. A T-score of -1 to +1 is considered normal bone density, a score between -1 and -2.5 indicates osteopenia (low bone mass), and a score of -2.5 or lower indicates osteoporosis. |
| Secondary | Safety and Tolerability of ACTH: Bruising | Month 36 | Count of participants self reporting at any time throuhgout the study that they bruise more easily |
| Secondary | Safety and Tolerability of ACTH: Swelling Ankles | Month 36 | Count of participants self reporting at any time throuhgout the study that have noticed swelling in their ankles |
| Secondary | Safety and Tolerability of ACTH: Hair Loss | Month 36 | Count of participants self reporting at any time throuhgout the study that have noticed losing more hair |
| Secondary | Safety and Tolerability of ACTH: Acne | Month 36 | Count of participants self reporting at any time throuhgout the study that have noticed in increase in acne |
| Secondary | Safety and Tolerability of ACTH: Insomnia | Month 36 | Count of participants self reporting at any time throuhgout the study that they have been having trouble sleeping |
| Secondary | Safety and Tolerability of ACTH: Mood Change | Month 36 | Count of participants self reporting at any time throuhgout the study that they have noticed changes in mood |
| Secondary | Safety and Tolerability of ACTH: GI Upset | Month 36 | Count of participants self reporting at any time throuhgout the study that they have had upset stomach, indigestion, diarrhea, or bloating |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients Exhibiting a 20% Worsening in T25FW at 36 Months | Month 36 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Safety and Tolerability of ACTH: Menstrual Changes [Female] | Month 36 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Safety and Tolerability of ACTH: DEXA Scans | Month 36 | units on a scale | MEAN | |
| SECONDARY | Safety and Tolerability of ACTH: Bruising | Month 36 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Safety and Tolerability of ACTH: Swelling Ankles | Month 36 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Safety and Tolerability of ACTH: Hair Loss | Month 36 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Safety and Tolerability of ACTH: Acne | Month 36 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Safety and Tolerability of ACTH: Insomnia | Month 36 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Safety and Tolerability of ACTH: Mood Change | Month 36 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Safety and Tolerability of ACTH: GI Upset | Month 36 | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients Exhibiting a 20% Worsening in T25FW at 36 Months | ACTH | 3 | Participants | ||
| Proportion of Patients Exhibiting a 20% Worsening in T25FW at 36 Months | Placebo | 4 | Participants | ||
| Safety and Tolerability of ACTH: Menstrual Changes [Female] | ACTH | 1 | Participants | ||
| Safety and Tolerability of ACTH: Menstrual Changes [Female] | Placebo | 1 | Participants | ||
| Safety and Tolerability of ACTH: DEXA Scans | ACTH | -0.41 | Standard Deviation 0.49 | units on a scale | |
| Safety and Tolerability of ACTH: DEXA Scans | Placebo | 0 | Standard Deviation 0.5 | units on a scale | |
| Safety and Tolerability of ACTH: Bruising | ACTH | 7 | Participants | ||
| Safety and Tolerability of ACTH: Bruising | Placebo | 8 | Participants | ||
| Safety and Tolerability of ACTH: Swelling Ankles | ACTH | 15 | Participants | ||
| Safety and Tolerability of ACTH: Swelling Ankles | Placebo | 9 | Participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ACTH | 29 | |
| Overall Study | STARTED | Placebo | 30 | |
| Overall Study | COMPLETED | ACTH | 11 | |
| Overall Study | COMPLETED | Placebo | 9 | |
| Overall Study | NOT COMPLETED | ACTH | 18 | |
| Overall Study | NOT COMPLETED | Placebo | 21 |
Source ClinicalTrials.gov
Adverse events56
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 | Alopecia | General disorders | ACTH | 4 | 29 | 4 |
| other | Alopecia | General disorders | Placebo | 6 | 30 | 7 |
| other | Bladder function | Renal and urinary disorders | ACTH | 5 | 29 | 5 |
| other | Bladder function | Renal and urinary disorders | Placebo | 2 | 30 | 2 |
| other | Bruising | General disorders | ACTH | 7 | 29 | 7 |
| other | Bruising | General disorders | Placebo | 11 | 30 | 11 |
| other | cardiovascular | Cardiac disorders | ACTH | 14 | 29 | 17 |
| other | cardiovascular | Cardiac disorders | Placebo | 8 | 30 | 10 |
| other | dermatologic | General disorders | ACTH | 7 | 29 | 10 |
| other | dermatologic | General disorders | Placebo | 10 | 30 | 12 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ACTH | 0 | 29 |
| Total, all-cause mortality | Placebo | 0 | 30 |
| Total, other adverse events | ACTH | 29 | 29 |
| Total, other adverse events | Placebo | 29 | 30 |
| Total, serious adverse events | ACTH | 8 | 29 |
| Total, serious adverse events | Placebo | 7 | 30 |
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 comparisons22
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ACTH vs Placebo: Safety and Tolerability of ACTH: Skin Thinning | Trial comparisons |
| ACTH vs Placebo: Safety and Tolerability of ACTH: Mood Change | Trial comparisons |
| ACTH vs Placebo: Safety and Tolerability of ACTH: Fatigue | Trial comparisons |
| ACTH vs Placebo: Safety and Tolerability of ACTH: Acne | Trial comparisons |
| ACTH vs Placebo: Safety and Tolerability of ACTH: Hair Loss | Trial comparisons |
| ACTH vs Placebo: Safety and Tolerability of ACTH: Hair Loss | Trial comparisons |
| ACTH vs Placebo: Safety and Tolerability of ACTH: GI Upset | Trial comparisons |
| ACTH vs Placebo: Safety and Tolerability of ACTH: Blurred Vision | Trial comparisons |
| ACTH vs Placebo: Safety and Tolerability of ACTH: Unpleasant Taste | Trial comparisons |
| ACTH vs Placebo: Safety and Tolerability of ACTH: Moon Facies | Trial comparisons |
1 to 10 of 22
See all 22 trial comparisonsTests0
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/NCT01950234
GET https://conductscience.org/api/trials/v1/NCT01950234/registered?page=2