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

Last updated: February 5, 2020
Sponsor: Louisiana State University Health Sciences Center in New Orleans
Overall Status: Active - Recruiting

Phase

1/2

Condition

Epilepsy

Epilepsy (Pediatric)

Treatment

N/A

Clinical Study ID

NCT04219995
IRB# 19-179
  • Ages 2-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients age 2 -18 years of age

  2. Patients who have at least 4 convulsive (generalized tonic or tonic-clonic) seizuresper month on 2 or more anti-epileptic drugs (AEDs) at therapeutic doses a. Epilepsy diagnosed by historical clinical evidence

  3. Family's ability to understand and willingness to sign a written informed consentdocument for patients under 18.

  4. Willingness to complete seizure diary for duration of study

  5. Willingness to present to all study visits

Exclusion

Exclusion Criteria:

  1. Patients with history of the following diagnoses:

  2. Traumatic brain injury

  3. Tuberous sclerosis

  4. Sturge Weber

  5. Cortical dysplasia

  6. Patients with known hereditary degenerative diseases as follows:

  7. Adrenoleukodystrophy

  8. Neuronal ceroid lipofuscinosis

  9. Leigh Syndrome

  10. Myoclonic epilepsy with ragged red fibers (MERRF)

  11. Rett Syndrome

  12. Patients with the following epilepsy syndromes

  13. Infantile spasms

  14. West Syndrome

  15. Progressive myoclonic epilepsy

  16. Dravet syndrome

  17. Doose syndrome

  18. Ohtahara syndrome

  19. Rasmussen's encephalitis

  20. Patients with the following metabolic disorders

  21. Phenylketonuria

  22. Maple syrup urine disease

  23. Organic acidemias

  24. Galactosemia

  25. Peroxismal disorders (e.g. Zellwegers)

  26. Lysosomal disorders

  27. Urea cycle disorders

  28. Patients with history of immunodeficiency

  29. Patients with the following infections

  30. HIV/AIDS

  31. Active or latent TB

  32. Active or suspected bacterial infection

  33. Active, latent or suspected fungemia

  34. Active or suspected parasitic infection

  35. Patients with history of malignancy

  36. Patients with history of or active myopathy

  37. Patients with degenerative neuromuscular disorders

  38. Patients with history of hypersensitivity or allergic reactions to corticosteroids

  39. Patients with history of psychosis

  40. Patients with diabetes mellitus

  41. Pregnancy

  42. Any underlying predisposition to gastrointestinal bleeding (peptic ulcer disease,gastritis, colitis)

Study Design

Total Participants: 10
Study Start date:
February 03, 2020
Estimated Completion Date:
February 28, 2021

Connect with a study center

  • Children's Hospital of New Orleans

    New Orleans, Louisiana 70118
    United States

    Active - Recruiting

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