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Study · Randomized controlled trial · n = 18 · 2011

3 results

Five-day regimen of intramuscular or subcutaneous self-administered adrenocorticotropic hormone gel for acute exacerbations of multiple sclerosis: a prospective, randomized, open-label pilot trial.

Simsarian JP, Saunders C, Smith DM

Drug design, development and therapy11 Jul 2011Cited by 27 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study3

3 results from studies that gave the peptide. 3 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with multiple sclerosis exacerbations, intramuscular and subcutaneous ACTH gel did not differ significantly in day 14 responder proportions.

    In plain wordsIn patients with multiple sclerosis exacerbations, response rates did not differ significantly between intramuscular and subcutaneous ACTH gel.

    Outcome
    No significant changePGI-C response by injection route at day 14
    Study

    n = 18

    Comparator
    Subcutaneous ACTH gel
    Analysis
    Primary
    Outcome group
    Exercise and physical function · Nervous system and cognition
    Studied dose
    80 U/day · intramuscular · five consecutive daysAs given in this study (human).

    Measurements

    P value
    0.3
    route comparison

    Source sentences

    Summary
    The intramuscular group had numerically more responders, but there was no significant difference in the proportion of responders between the intramuscular and subcutaneous groups at day 14 (P = 0.3).
    2 context sentences
    Summary · context
    At our clinic, we performed a small, prospective, randomized pilot study to examine the efficacy and safety of, and patient satisfaction with, a short (five-day) self-administered ACTH dosing protocol for exacerbations of multiple sclerosis, and to compare the subcutaneous and intramuscular routes of administration.
    Summary · context
    Each patient self-administered natural ACTH gel 80 U/day by subcutaneous or intramuscular injection for five consecutive days and was evaluated at baseline and on days 7 and 14.
  2. 02HumanRandomized controlled trialSafety outcome

    In patients with multiple sclerosis exacerbations, intramuscular ACTH gel was associated with more injection site pain than subcutaneous ACTH gel.

    In plain wordsIn patients with multiple sclerosis exacerbations, intramuscular ACTH gel was linked to more injection site pain than subcutaneous ACTH gel.

    Outcome
    IncreaseInjection site pain
    Study

    n: not reported in source

    Comparator
    Subcutaneous ACTH gel
    Outcome group
    Adverse events · Whole body
    Studied dose
    80 U/day · intramuscular · five consecutive daysAs given in this study (human).

    Source sentences

    Summary
    The intramuscular route of injection was associated with more injection site pain than the subcutaneous route.
    2 context sentences
    Summary · context
    At our clinic, we performed a small, prospective, randomized pilot study to examine the efficacy and safety of, and patient satisfaction with, a short (five-day) self-administered ACTH dosing protocol for exacerbations of multiple sclerosis, and to compare the subcutaneous and intramuscular routes of administration.
    Summary · context
    Each patient self-administered natural ACTH gel 80 U/day by subcutaneous or intramuscular injection for five consecutive days and was evaluated at baseline and on days 7 and 14.
  3. 03HumanNon-randomized trialEfficacy outcome

    In patients with multiple sclerosis exacerbations, 61.1% responded on PGI-C at day 14 after natural ACTH gel.

    In plain wordsIn patients with multiple sclerosis exacerbations, 61.1% reported much or very much improvement after ACTH gel.

    Outcome
    IncreasePGI-C treatment response at day 14
    Study

    n = 18

    Analysis
    Primary
    Outcome group
    Exercise and physical function · Nervous system and cognition
    Studied dose
    80 U/day · subcutaneous or intramuscular · five consecutive daysAs given in this study (human).

    Measurements

    Responders
    61.1%
    day 14
    Responders
    11 patients
    18 with day 14 scores

    Source sentences

    Summary
    On day 14, 61.1% of patients (11 of 18 with day 14 scores) were treatment responders, and rated their condition as "very much improved" or "much improved" on the PGI-C.
    2 context sentences
    Summary · context
    At our clinic, we performed a small, prospective, randomized pilot study to examine the efficacy and safety of, and patient satisfaction with, a short (five-day) self-administered ACTH dosing protocol for exacerbations of multiple sclerosis, and to compare the subcutaneous and intramuscular routes of administration.
    Summary · context
    Each patient self-administered natural ACTH gel 80 U/day by subcutaneous or intramuscular injection for five consecutive days and was evaluated at baseline and on days 7 and 14.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

Status unknownPhase 2NCT03465111

A Clinical Study to Evaluate the Potential Role of ACTH Gel in Patients With Scleritis

Metropolitan Eye Research & Surgery Instituten = 301 Jan 2019 to est. 8 Dec 2024

Scleritis

Trial pageClinicalTrials.govUpdated 23 Oct 2023
CompletedPhase 2Results postedNCT01906372

Acthar in Treatment of Refractory Dermatomyositis and Polymyositis

Rohit Aggarwal, MDn = 12Sept 2013 to May 2016

Dermatomyositis · Polymyositis

Trial pageClinicalTrials.govUpdated 1 Sept 2017

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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