Pilot Trial to Evaluate The Effect of Oral Methylprednisolone on Seizure Frequency in Children With Epilepsy

  • STATUS
    Recruiting
  • participants needed
    10
  • sponsor
    Louisiana State University Health Sciences Center in New Orleans
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Updated on 16 February 2024
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corticosteroids
epilepsy
methylprednisolone
tonic
seizure
antiepileptic
oral methylprednisolone

Summary

Although corticosteroids have been shown to be beneficial anecdotally for refractory epilepsy, the effects of corticosteroids on pediatric epilepsy have primarily been studied retrospectively amongst a heterogeneous patient population. The objective of this prospective cross-over study is to determine the effect of oral steroids on convulsive seizure frequency and evaluate the tolerability of pulsed oral steroids. Participants will be prospectively enrolled from pediatric neurology clinic at Children's Hospital of New Orleans, and baseline seizure frequency will be assessed. Participants will then be randomized to receive either the study drug, methylprednisolone, or placebo during the first month, followed by a one-month wash-out period. During the third month of the study, participants will enter the cross-over phase of the study where those who received methylprednisolone will receive placebo, and those who received placebo will receive methylprednisolone. The primary outcome will be the percentage of patients with 50% or more reduction in seizure frequency following one course of oral methylprednisolone. frequency following 1 course of oral methylprednisolone.

Details
Condition Seizure, Epilepsy, Epilepsy
Age 2years - 18years
Treatment Placebo, methylprednisolone sodium succinate
Clinical Study IdentifierNCT04219995
SponsorLouisiana State University Health Sciences Center in New Orleans
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients age 2 -18 years of age
Patients who have at least 4 convulsive (generalized tonic or tonic-clonic) seizures per month on 2 or more anti-epileptic drugs (AEDs) at therapeutic doses
Epilepsy diagnosed by historical clinical evidence
Family's ability to understand and willingness to sign a written informed consent document for patients under 18
Willingness to complete seizure diary for duration of study
Willingness to present to all study visits

Exclusion Criteria

Patients with history of the following diagnoses
Traumatic brain injury
Tuberous sclerosis
Sturge Weber
Cortical dysplasia
Patients with known hereditary degenerative diseases as follows
Adrenoleukodystrophy
Neuronal ceroid lipofuscinosis
Leigh Syndrome
Myoclonic epilepsy with ragged red fibers (MERRF)
Rett Syndrome
Patients with the following epilepsy syndromes
Infantile spasms
West Syndrome
Progressive myoclonic epilepsy
Dravet syndrome
Doose syndrome
Ohtahara syndrome
Rasmussen's encephalitis
Patients with the following metabolic disorders
Phenylketonuria
Maple syrup urine disease
Organic acidemias
Galactosemia
Peroxismal disorders (e.g. Zellwegers)
Lysosomal disorders
Urea cycle disorders
Patients with history of immunodeficiency
Patients with the following infections
HIV/AIDS
Active or latent TB
Active or suspected bacterial infection
Active, latent or suspected fungemia
Active or suspected parasitic infection
Patients with history of malignancy
Patients with history of or active myopathy
Patients with degenerative neuromuscular disorders
Patients with history of hypersensitivity or allergic reactions to corticosteroids
Patients with history of psychosis
Patients with diabetes mellitus
Pregnancy
Any underlying predisposition to gastrointestinal bleeding (peptic ulcer disease, gastritis, colitis)
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