ACTH for Fatigue in Multiple Sclerosis Patients
The Effect of ACTH (Acthar) on Measures of Chronic Fatigue in Patients With Relapsing Multiple Sclerosis.
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Corticotropin
Melanocortin receptor 2 agonist
Placebo
- Placebo
Results by group
Fatigue at 28 Weeks
28 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| ACTH | 56.50 score on a scale | 21–74 | 4 |
| Placebo | 29.00 score on a scale | 5–74 | 4 |
| ACTH | 55.00 score on a scale | 25–63 | 4 |
| Placebo | 40.00 score on a scale | 25–57 | 4 |
ACTH
Placebo
ACTH
Placebo
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| ACTH | 4 | 0 (0.0%) | 0 |
| Placebo | 4 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Fatigue at 28 Weeks
28 weeks
FatigueQuality of life (reported by participants)
Other measures (3)
Depression at 28 Weeks
28 weeks
Mood and sleepQuality of life (reported by participants)Sleepiness at 28 Weeks
28 weeks
Mood and sleepQuality of life (reported by participants)Quality of Life at 28 Weeks
28 weeks
Quality of life (reported by participants)
Who could take part
Relapsing MS · 18 to 65 · EDSS 0 to 4
Show the full criteria
Inclusion criteria
* Have documented diagnosis of Relapsing MS as defined by McDonald Criteria 2011 Revision for at least 6 months * Have been treated with interferon beta 1a or 1b, glatiramer acetate, fingolimod, dimethyl fumarate, or teriflunomide for at least 6 months, with reported adherence rate of at least 75%, at time of screening * Have an Kurtzke Expanded Disability Status Scale (EDSS) score of 0 to 4, inclusive * Have Modified Fatigue Impact Scale (MFIS) ≥ 38 or Functional Systems Scores (FSS) ≥ 36, Beck Depression Inventory-II (BDI-II) greater than or equal to 19, and Expanded Disability Status Scale (EDSS) greater than or equal to 9 * Women of childbearing potential must employ proven methods to prevent pregnancy during the course of the trial * Able to understand the purpose and risks of the study * Must be willing to sign an inform consent * Must be willing to follow the protocol requirements * Subject must agree not to receive any live or live-attenuated vaccine during the trial
Exclusion criteria
* Have any of the contraindications for Acthar Gel as listed in the approved label, including sensitivity to proteins of porcine origin. * Had treatment of systemic or oral corticosteroids of any type in 90 days prior to baseline/randomization * Had a relapse or documented objective neurologic worsening in 90 days prior to baseline/randomization * Has concurrent neurological disease other than multiple sclerosis * History of sleep apnea * History (within 90 days) of nocturnal pain and / or nocturnal spasms that interferes with or disrupts sleep, or uncontrolled nocturnal restless leg syndrome * History of psychosis, bipolar disorder, mania/hypomania * History of coronary heart disease, congestive heart failure, chronic pulmonary disease, emphysema, anemia, bleeding disorder, gastrointestinal bleeding, intestinal ulcer, clinically significant cardiac arrhythmia, Type I or II diabetes, uncontrolled hypertension, seizure disorder, cardiac arrhythmia, immune deficiency disorder, HIV-AIDS, tuberculosis, or dysthyroidal state (patients with a history of hypothyroidism or hyperthyroidism, which has been corrected to physiological levels will not be excluded) * History of substance abuse, other than tobacco within the past 5 years or current alcohol dependence * Current use of cannabis, opiates, benzodiazepines, barbiturates, gabapentin, pregabalin, topiramate, divalproex sodium, carbamazepine, oxcarbazepine, or any gaba-ergic medications other than tizanidine or Baclofen, which are permitted for spasticity treatment * History of any malignant neoplasm except for past basal cell or squamous cell carcinoma of the skin, that has been successfully treated prior to the screening visit * History of psychosis or history of use of neuroleptics including, but not restricted to, haloperidol, chlorpromazine, aripiprazole, olanzapine, risperidone * History of suicide attempt, current suicidal thinking or is preparing for suicide * Current use of Amphetamines or methylphenidate * Current use of modafinil, or armodafinil * Current use of amantidine * The subject must have had a medication-free interval of: a. 7 days for prior use of: i. methylphenidate, amphetamine or dextroamphetamine ii. modafinil or armodafinil iii. diphenhydramine, phenylephrine, loratadine iv. gabapentin, pregabalin, topiramate, valproate/divalproex v. oxcarbazepine vi. codeine, hydrocodone, oxycodone, diphenhydramine, phenylephrine, gabapentin, pregabalin, topiramate, valproate/divalproex, oxcarbazepine, codeine, hydrocodone, oxycodone b. 14 days for prior use of: i. desloratadine ii. Amantidine iii. alprazolam, lorazepam, morphine, hydromorphone, amantidine, alprazolam, lorazepam iv. morphine, hydromorphone c. 28 days for prior use of: i. clonazepam ii. cannabis or other cannabinoids d. 90 days for prior use of carbamazepine
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a study of Acthar gel (ACTH) in patients with relapsing multiple sclerosis who are experiencing chronic fatigue.
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History
Started
May 2015
Main results due
Jun 2017
Finished
Dec 2018
Results posted
Aug 2019