Fatigue at 28 Weeks
| Group | Value (score on a scale) |
|---|---|
| ACTH | 56.50 |
| Placebo | 29.00 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name ACTH
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a study of Acthar gel (ACTH) in patients with relapsing multiple sclerosis who are experiencing chronic fatigue.
Experimental
ACTH
The study drug (ACTH 40 units) will be given subcutaneously twice weekly for 2 weeks. If the patient tolerates this dosage regimen, the dose will be increased to 80 units twice weekly. If the 80 unit dosage is not tolerated, the dosage will be reduced to 40 units twice weekly for the remainder of the 24 week participation. The weekly doses will be given 3 days apart, for example, on every Monday and Thursday or every Tuesday and Friday.
Placebo comparator
Placebo
Placebo will be given subcutaneously twice weekly for 28 weeks.
Outcomes the sponsor listed as primary.
Fatigue at 28 Weeks
Time frame · 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.
Depression at 28 Weeks
Time frame · 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.
Sleepiness at 28 Weeks
Time frame · 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'.
Quality of Life at 28 Weeks
Time frame · 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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (score on a scale) |
|---|---|
| ACTH | 56.50 |
| Placebo | 29.00 |
| Group | Value (score on a scale) |
|---|---|
| ACTH | 16.50 |
| Placebo | 40.00 |
| Group | Value (score on a scale) |
|---|---|
| ACTH | 11.00 |
| Placebo | 7.00 |
| Group | Value (score on a scale) |
|---|---|
| ACTH | 39.50 |
| Placebo | 49.00 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ACTHThe study drug (ACTH 40 units) will be given subcutaneously twice weekly for 2 weeks. If the patient tolerates this dosage regimen, the dose will be increased to 80 units twice weekly. If the 80 unit dosage is not tolerated, the dosage will be reduced to 40 units twice weekly for the remainder of the 24 week participation. The weekly doses will be given 3 days apart, for example, on every Monday and Thursday or every Tuesday and Friday. ACTH: ACTH injections twice weekly for 28 weeks. | 0 / 4 | 0 / 4 | 4 / 4 |
| PlaceboPlacebo will be given subcutaneously twice weekly for 28 weeks. Placebo: Placebo injections twice weekly for 28 weeks. | 0 / 4 | 0 / 4 | 3 / 4 |
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