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Multiple Sclerosis, Relapsing-RemittingPhase 3ACTHNCT02315872

ACTH for Fatigue in Multiple Sclerosis Patients

A Phase 3 study testing ACTH in people with Multiple Sclerosis, Relapsing-Remitting, run by Providence Health & Services at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a study of Acthar gel (ACTH) in patients with relapsing multiple sclerosis who are experiencing chronic fatigue. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis, Relapsing-Remitting
What is being tested?
ACTH
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
5 sitesUnited States
Study dates
22 May 2015to 13 Dec 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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:
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • North Central Neurology Associates, PC

    Cullman, Alabama, 35058

  • Providence Medical Group - Medford Neurology

    Medford, Oregon, 97504

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Swedish Medical Center

    Seattle, Washington, 98122

  • MultiCare Health System -- Institute for Research and Innovation

    Tacoma, Washington, 98405

Other trials in United States

About this study

Official title: The Effect of ACTH (Acthar) on Measures of Chronic Fatigue in Patients With Relapsing Multiple Sclerosis.

This is a study of Acthar gel (ACTH) in patients with relapsing multiple sclerosis who are experiencing chronic fatigue.

Read the detailed description

This is a multi-center, randomized, double-blind, placebo-controlled study to demonstrate the safety, tolerability, and effect of ACTH on fatigue in patients with relapsing multiple sclerosis (RMS). The primary objective of this study is to assess the efficacy of ACTH versus placebo in reducing fatigability in patients with RMS. Secondary objectives include assessment of the tolerability and safety of twice-weekly ACTH treatment vs. placebo and evaluation of ACTH on depression, sleepiness, and quality of life measures and correlations between these measures.

Being tested
ACTH, Placebo
Keywords
Multiple Sclerosis, Acthar Gel, ACTH, Fatigue
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACTHDrug

    Also called Acthar Gel, Repository Corticotropin Injection

    ACTH injections twice weekly for 28 weeks.

  • PlaceboDrug

    Also called Control

    Placebo injections twice weekly for 28 weeks.

Study groups in NCT02315872
Study groupRoleWhat they receive
ACTHExperimentalThe 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.
Receives: Drug: ACTH
PlaceboPlacebo comparatorPlacebo will be given subcutaneously twice weekly for 28 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fatigue at 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.

    Measured: 28 weeks

Secondary outcomes (3)

  1. Depression at 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.

    Measured: 28 weeks

  2. Sleepiness at 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'.

    Measured: 28 weeks

  3. Quality of Life at 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.

    Measured: 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2014 (estimated)
  2. Study start22 May 2015
  3. Primary completion20 Jun 2017
  4. Study completion13 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02315872
Sponsor's protocol ID
13-120A
Acronym
ACTH
Status last verified
Aug 2019
First submitted
9 Dec 2014
Last updated
9 Sep 2019
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ACTH in people with Multiple Sclerosis, Relapsing-Remitting, run by Providence Health & Services at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue at 28 Weeks (time frame: 28 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02315872.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019; AzTrials last refreshed its copy on 30 Oct 2026.

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