Trial · NCT02315872

ACTH for Fatigue in Multiple Sclerosis Patients

NCT02315872, Phase 3, Completed, Providence Health & Services; results first posted 2019-08-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. ACTH for Fatigue in Multiple Sclerosis Patients. Trials, record NCT02315872. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02315872

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: ACTH for Fatigue in Multiple Sclerosis Patients
NCT number: NCT02315872
Status: Completed
Phases: Phase 3
Enrollment: 8 participants, actual
Lead sponsor: Providence Health & Services
Conditions: Multiple Sclerosis, Relapsing-Remitting
Interventions: ACTH, Placebo
First posted: 2014-12-12
Last updated: 2019-09-09
Results first posted: 2019-08-13

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Fatigue at 28 Weeks	28 weeks	Patient-reported levels of fatigue as measured by score on the Modified Fatigue Impact Scale (MFIS) and the Fatigue Severity Scale (FSS) at 28 weeks. The full-length MFIS consists of 21 items. A higher score on the MFIS indicates a greater impact of fatigue on a patient's activities. The FSS is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Higher scores on each scale indicate a greater severity of fatigue.
Secondary	Depression at 28 Weeks	28 weeks	Patient-reported depression as measured by the Beck Depression Inventory-II (BDI-II) at 28 weeks. The BDI-II is a 21-item self-report multiple-choice inventory used as an indicator of the severity of depression. A higher score indicates a greater severity of depression.
Secondary	Sleepiness at 28 Weeks	28 weeks	Patient-reported daytime sleepiness as measure by the Epworth Sleepiness Scale (ESS) at 28 weeks. The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'.
Secondary	Quality of Life at 28 Weeks	28 weeks	Patient-reported quality of life as measured by the 36-Item Short Form Health Survey (SF-36) at 28 weeks. The SF-36 is a 36-item, patient-reported survey of patient mental and physical health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Fatigue at 28 Weeks	28 weeks	score on a scale	MEDIAN
SECONDARY	Depression at 28 Weeks	28 weeks	score on a scale	MEDIAN
SECONDARY	Sleepiness at 28 Weeks	28 weeks	score on a scale	MEDIAN
SECONDARY	Quality of Life at 28 Weeks	28 weeks	score on a scale	MEDIAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Fatigue at 28 Weeks	ACTH	MFIS	56.50	Full Range 21 to 74	score on a scale
Fatigue at 28 Weeks	Placebo	MFIS	29.00	Full Range 5 to 74	score on a scale
Fatigue at 28 Weeks	ACTH	FSS	55.00	Full Range 25 to 63	score on a scale
Fatigue at 28 Weeks	Placebo	FSS	40.00	Full Range 25 to 57	score on a scale
Depression at 28 Weeks	ACTH		16.50	Full Range 0 to 22	score on a scale
Depression at 28 Weeks	Placebo		40.00	Full Range 25 to 57	score on a scale
Sleepiness at 28 Weeks	ACTH		11.00	Full Range 2 to 16	score on a scale
Sleepiness at 28 Weeks	Placebo		7.00	Full Range 1 to 19	score on a scale
Quality of Life at 28 Weeks	ACTH	SF-36 Mental	39.50	Full Range 25 to 57	score on a scale
Quality of Life at 28 Weeks	Placebo	SF-36 Mental	49.00	Full Range 34 to 68	score on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	ACTH	4
Overall Study	STARTED	Placebo	4
Overall Study	COMPLETED	ACTH	1
Overall Study	COMPLETED	Placebo	3
Overall Study	NOT COMPLETED	ACTH	3
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events76

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	bronchitis	Infections and infestations	ACTH	1	4	1
other	bronchitis	Infections and infestations	Placebo	1	4	1
other	Sinus infection	Infections and infestations	ACTH	1	4	1
other	Sinus infection	Infections and infestations	Placebo	1	4	1
other	Flu	Infections and infestations	ACTH	2	4	2
other	Flu	Infections and infestations	Placebo	0	4	0
other	incontinence	Gastrointestinal disorders	ACTH	0	4	0
other	incontinence	Gastrointestinal disorders	Placebo	1	4	1
other	heartburn	Gastrointestinal disorders	ACTH	0	4	0
other	heartburn	Gastrointestinal disorders	Placebo	1	4	1

1 to 10 of 76Source ClinicalTrials.gov

See all 76 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ACTH	0	4
Total, all-cause mortality	Placebo	0	4
Total, other adverse events	ACTH	4	4
Total, other adverse events	Placebo	3	4
Total, serious adverse events	ACTH	0	4
Total, serious adverse events	Placebo	0	4

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
ACTH vs Placebo: deaths from any cause	Trial comparisons
ACTH 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02315872

GET https://conductscience.org/api/trials/v1/NCT02315872/events?page=2

API reference For AI assistants