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Trial · Interventional

CompletedPhase 3Results postedRegistry data

ACTH for Fatigue in Multiple Sclerosis Patients

Short name ACTH

Overview

Status
Completed
Phase
Phase 3
Enrollment
8 participants (actual)
Sponsor
Providence Health & Services · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
22 May 2015
Primary completion
20 Jun 2017
Completion
13 Dec 2018
First posted
12 Dec 2014 (estimated)
Last update posted
9 Sept 2019
Conditions
Multiple Sclerosis, Relapsing-Remitting

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016201720182019
  1. Ph 3

    ACTH

    NCT02315872

    22 May 2015 to 13 Dec 2018

Registry summary

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.

Interventions

  • ACTHDrug
  • PlaceboDrug

Arms2

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Fatigue at 28 Weeks

    Time frame · 28 weeks

    Registry description

    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 outcomes(3)
  1. Depression at 28 Weeks

    Time frame · 28 weeks

    Registry description

    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.

  2. Sleepiness at 28 Weeks

    Time frame · 28 weeks

    Registry description

    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'.

  3. Quality of Life at 28 Weeks

    Time frame · 28 weeks

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· 28 weeks

Fatigue at 28 Weeks

GroupValue (score on a scale)
ACTH56.50
Placebo29.00
Secondary and other outcome results(3)
Secondary outcomeMedian· 28 weeks

Depression at 28 Weeks

GroupValue (score on a scale)
ACTH16.50
Placebo40.00
Secondary outcomeMedian· 28 weeks

Sleepiness at 28 Weeks

GroupValue (score on a scale)
ACTH11.00
Placebo7.00
Secondary outcomeMedian· 28 weeks

Quality of Life at 28 Weeks

GroupValue (score on a scale)
ACTH39.50
Placebo49.00

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther 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 / 40 / 44 / 4
PlaceboPlacebo will be given subcutaneously twice weekly for 28 weeks. Placebo: Placebo injections twice weekly for 28 weeks.0 / 40 / 43 / 4

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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