Prednisolone or tetracosactide depot for infantile epileptic spasms syndrome? A prospective analysis of data embedded within two randomised controlled trials.

Osborne JP, Edwards SW, Alber FD, Hancock E, Johnson AL, Kennedy CR, Likeman M, Lux AL, Mackay M, Mallick A, Newton RW, Nolan M and 5 more

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Pressler R, Rating D, Schmitt B, Verity CM, O'Callaghan FK

European journal of paediatric neurology : EJPN : official journal of the European Paediatric Neurology Society26 Dec 2022Cited by 8 (Europe PMC)

PMID36621063DOI10.1016/j.ejpn.2022.12.007PepBankPUB-36621063

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Summary

ObjectiveTo report a prospectively planned analysis of two randomised controlled trials with embedded comparisons of prednisolone versus tetracosactide depot for the treatment of infantile epileptic spasms syndrome (IESS).MethodsIndividual patient data from patients randomly allocated to prednisolone or tetracosactide depot were analysed from two trials (UKISS, ICISS). The comparison was embedded within trials in which some patients also received vigabatrin but only patients receiving monotherapy with randomly allocated hormonal treatments are included in this analysis. The main outcome was cessation of spasms (Days 13-14 after randomisation). Lead time to treatment and underlying aetiology were taken into account. Cessation of spasms on Days 14-42 inclusive, electroclinical response (EEG Day 14), plus developmental and epilepsy outcomes (at 14 months in UKISS and 18 months in ICISS) are also reported. Minimum treatment was prednisolone 40 mg per day for two weeks or tetracosactide depot 0·5 mg IM on alternate days for two weeks, all followed by a reducing dose of prednisolone over two weeks.Results126 infants were included in this study. On tetracosactide depot, 47 of 62 (76%) were free of spasms on Days 13-14 compared to 43 of 64 (67%) on prednisolone (difference 9%, 95% CI -7·2% to +25·2%, chi square 1·15, p = 0·28). For Day 14-42 cessation of spasms, on tetracosactide depot, 41 of 61 (67%) were free of spasms compared to 35 of 62 (56%) on prednisolone (difference 11%, 95% CI -6·4% to +28·4%, chi square 1·51, p = 0·22). There was no significant difference in mean VABS score between infants who received prednisolone compared with those who received tetracosactide depot (74·8 (SD 18·3) versus 78·0 (SD 20·2) t = -0·91 p = 0·36). The proportion with ongoing epilepsy at the time of developmental assessment was 20 of 61 (33%) in the tetracosactide group compared with 26 out of 63 (41%) in the prednisolone group (difference 8%, 95% CI -9·2% to +25·2%, Chi [2] 0·95, p = 0·33).SignificanceWith hormone monotherapy, either prednisolone or tetracosactide depot may be recommended for infantile epileptic spasms syndrome.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In infants with epileptic spasms, cessation on tetracosactide versus prednisolone was 47/62 (76%) versus 43/64 (67%), without significant difference.
In plain wordsIn infants with epileptic spasms, tetracosactide and prednisolone did not differ significantly in early spasm cessation.
Peptide
Cosyntropin
Outcome
No significant changeSpasm cessation on Days 13-14
Study
n = 126
Comparator
Prednisolone
Analysis
Primary
Outcome group
Seizures · Nervous system and cognition
Studied dose
0·5 mg on alternate days · intramuscular · two weeksAs given in this study (human).
Measurements
Free of spasms, Days 13-14
76%
tetracosactide depot, 47 of 62
Free of spasms, Days 13-14
67%
prednisolone, 43 of 64
Difference in spasm freedom, Days 13-14
9%
tetracosactide depot minus prednisolone; p = 0.28
95% CI of difference
−7.2 to 25.2%
tetracosactide depot minus prednisolone
Source sentences
Summary
On tetracosactide depot, 47 of 62 (76%) were free of spasms on Days 13-14 compared to 43 of 64 (67%) on prednisolone (difference 9%, 95% CI -7·2% to +25·2%, chi square 1·15, p = 0·28).
2 context sentences(design, population, supporting numbers)
Summary · context
Individual patient data from patients randomly allocated to prednisolone or tetracosactide depot were analysed from two trials (UKISS, ICISS).
Summary · context
The comparison was embedded within trials in which some patients also received vigabatrin but only patients receiving monotherapy with randomly allocated hormonal treatments are included in this analysis.
Show in the study text Report a problemFND-3662106301
02HumanRandomized controlled trialEfficacy outcome
In infants with epileptic spasms, ongoing epilepsy affected 20/61 (33%) on tetracosactide versus 26/63 (41%) on prednisolone (p = 0·33).
In plain wordsIn infants with epileptic spasms, ongoing epilepsy did not differ significantly between tetracosactide and prednisolone.
Peptide
Cosyntropin
Outcome
No significant changeOngoing epilepsy
Study
n = 124
Comparator
Prednisolone
Outcome group
Seizures · Nervous system and cognition
Studied dose
0·5 mg on alternate days · intramuscular · two weeksAs given in this study (human).
Measurements
Ongoing epilepsy
33%
tetracosactide depot, 20 of 61
Ongoing epilepsy
41%
prednisolone, 26 of 63
Difference in ongoing epilepsy
8%
prednisolone minus tetracosactide depot per source wording; p = 0.33
95% CI of difference
−9.2 to 25.2%
as reported
Source sentences
Summary
The proportion with ongoing epilepsy at the time of developmental assessment was 20 of 61 (33%) in the tetracosactide group compared with 26 out of 63 (41%) in the prednisolone group (difference 8%, 95% CI -9·2% to +25·2%, Chi [2] 0·95, p = 0·33).
2 context sentences(design, population, supporting numbers)
Summary · context
Individual patient data from patients randomly allocated to prednisolone or tetracosactide depot were analysed from two trials (UKISS, ICISS).
Summary · context
The comparison was embedded within trials in which some patients also received vigabatrin but only patients receiving monotherapy with randomly allocated hormonal treatments are included in this analysis.
Show in the study text Report a problemFND-3662106304
03HumanRandomized controlled trialEfficacy outcome
In infants with epileptic spasms, cessation on tetracosactide versus prednisolone was 41/61 (67%) versus 35/62 (56%), without significant difference.
In plain wordsIn infants with epileptic spasms, tetracosactide and prednisolone did not differ significantly in later spasm cessation.
Peptide
Cosyntropin
Outcome
No significant changeSpasm cessation on Days 14-42
Study
n = 123
Comparator
Prednisolone
Outcome group
Seizures · Nervous system and cognition
Studied dose
0·5 mg on alternate days · intramuscular · two weeksAs given in this study (human).
Measurements
Free of spasms, Days 14-42
67%
tetracosactide depot, 41 of 61
Free of spasms, Days 14-42
56%
prednisolone, 35 of 62
Difference in spasm freedom, Days 14-42
11%
tetracosactide depot minus prednisolone; p = 0.22
95% CI of difference
−6.4 to 28.4%
tetracosactide depot minus prednisolone
Source sentences
Summary
For Day 14-42 cessation of spasms, on tetracosactide depot, 41 of 61 (67%) were free of spasms compared to 35 of 62 (56%) on prednisolone (difference 11%, 95% CI -6·4% to +28·4%, chi square 1·51, p = 0·22).
2 context sentences(design, population, supporting numbers)
Summary · context
Individual patient data from patients randomly allocated to prednisolone or tetracosactide depot were analysed from two trials (UKISS, ICISS).
Summary · context
The comparison was embedded within trials in which some patients also received vigabatrin but only patients receiving monotherapy with randomly allocated hormonal treatments are included in this analysis.
Show in the study text Report a problemFND-3662106302
04HumanRandomized controlled trialEfficacy outcome
In infants with epileptic spasms, VABS scores did not differ significantly between tetracosactide (78·0, SD 20·2) and prednisolone (74·8, SD 18·3).
In plain wordsIn infants with epileptic spasms, developmental scores did not differ significantly between tetracosactide and prednisolone.
Peptide
Cosyntropin
Outcome
No significant changeVABS developmental score
Study
n: not reported in source
Comparator
Prednisolone
Outcome group
Cell proliferation and differentiation · Nervous system and cognition
Studied dose
0·5 mg on alternate days · intramuscular · two weeksAs given in this study (human).
Measurements
Mean VABS score
78 score
tetracosactide depot, SD 20.2
Mean VABS score
74.8 score
prednisolone, SD 18.3
Source sentences
Summary
There was no significant difference in mean VABS score between infants who received prednisolone compared with those who received tetracosactide depot (74·8 (SD 18·3) versus 78·0 (SD 20·2) t = -0·91 p = 0·36).
2 context sentences(design, population, supporting numbers)
Summary · context
Individual patient data from patients randomly allocated to prednisolone or tetracosactide depot were analysed from two trials (UKISS, ICISS).
Summary · context
The comparison was embedded within trials in which some patients also received vigabatrin but only patients receiving monotherapy with randomly allocated hormonal treatments are included in this analysis.
Show in the study text Report a problemFND-3662106303

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Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

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Prednisolone or tetracosactide depot for infantile epileptic spasms syndrome? A prospective analysis of data embedded within two randomised controlled trials.

Summary

Results from this study4

Version history

Subjects

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Keywords