Pilot Trial to Evaluate The Effect of Oral Methylprednisolone on Seizure Frequency in Children With Epilepsy
Status:
Recruiting
Trial end date:
2021-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Louisiana State University Health Sciences Center in New Orleans