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Study · Non-randomized trial · n = 25 · 2004

2 results

The United Kingdom Infantile Spasms Study comparing vigabatrin with prednisolone or tetracosactide at 14 days: a multicentre, randomised controlled trial.

Lux AL, Edwards SW, Hancock E, Johnson AL, Kennedy CR, Newton RW, O'Callaghan FJ, Verity CM, Osborne JP

Lancet (London, England)1 Nov 2004Cited by 264 (Europe PMC)

PMID15541450 (opens in a new tab)DOI10.1016/s0140-6736(04)17400-x (opens in a new tab)PepBankPUB-15541450
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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study2

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In infants assigned tetracosactide, 19/25 (76%) had no spasms on days 13 and 14.

    In plain wordsIn infants assigned tetracosactide, 19/25 (76%) had no spasms on days 13 and 14.

    Peptide
    Cosyntropin
    Outcome
    Not applicableCessation of spasms on days 13 and 14
    Study

    n = 25

    Analysis
    Primary
    Outcome group
    Seizure Control · Nervous system and cognition
    Studied dose
    Minimum 0.5 mg (40 IU) on alternate days · intramuscularAs given in this study (human).

    Measurements

    Infants with no spasms on days 13 and 14
    76%
    tetracosactide arm
    Infants with no spasms on days 13 and 14
    19 infants
    tetracosactide arm, of 25

    Source sentences

    Summary
    Proportions with no spasms on days 13 and 14 were: 40 (73%) of 55 infants assigned hormonal treatments (prednisolone 21/30 [70%], tetracosactide 19/25 [76%]) and 28 (54%) of 52 infants assigned vigabatrin (difference 19%, 95% CI 1%-36%, p=0.043).
    4 context sentences
    Summary · context
    The United Kingdom Infantile Spasms Study assessed these treatments in a multicentre, randomised controlled trial in 150 hospitals in the UK.
    Summary · context
    Minimum doses were vigabatrin 100 mg/kg per day, oral prednisolone 40 mg per day, or intramuscular tetracosactide depot 0.5 mg (40 IU) on alternate days.
    Summary · context
    Analysis was by intention to treat.
    Summary · context
    Of 208 infants screened and assessed, 107 were randomly assigned to vigabatrin (n=52) or hormonal treatments (prednisolone n=30, tetracosactide n=25).
  2. 02HumanNon-randomized trialSafety outcome

    In the infantile spasms trial, no deaths occurred, including among infants assigned tetracosactide.

    In plain wordsNo infants died in the trial, including infants assigned tetracosactide.

    Peptide
    Cosyntropin
    Outcome
    Not applicableDeaths
    Study

    n = 25

    Outcome group
    Mortality · Whole body
    Studied dose
    Minimum 0.5 mg (40 IU) on alternate days · intramuscularAs given in this study (human).

    Source sentences

    Summary
    No deaths were recorded.
    4 context sentences
    Summary · context
    The United Kingdom Infantile Spasms Study assessed these treatments in a multicentre, randomised controlled trial in 150 hospitals in the UK.
    Summary · context
    Minimum doses were vigabatrin 100 mg/kg per day, oral prednisolone 40 mg per day, or intramuscular tetracosactide depot 0.5 mg (40 IU) on alternate days.
    Summary · context
    Analysis was by intention to treat.
    Summary · context
    Of 208 infants screened and assessed, 107 were randomly assigned to vigabatrin (n=52) or hormonal treatments (prednisolone n=30, tetracosactide n=25).

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

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, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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