Overview

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

Inclusion Criteria:

1. Patients age 2 -18 years of age
2. 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
3. Epilepsy diagnosed by historical clinical evidence
4. Family's ability to understand and willingness to sign a written informed consent document for patients under 18.
5. Willingness to complete seizure diary for duration of study
6. Willingness to present to all study visits

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)