Pilot Trial to Evaluate The Effect of Oral Methylprednisolone on Seizure Frequency in Children With Epilepsy
Status unconfirmed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Intractable Epilepsy, Convulsive Seizures
In brief
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.
Key facts
- Study ID
- NCT04219995
- Run by
- Louisiana State University Health Sciences Center in New Orleans
- People needed
- 10
- Starts
- 2020-02-03
- Expected to finish
- 2021-02-01
- Last updated by the study team
- 2020-02-07
Who can join
Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- a. 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
You may not qualify if…
- 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)
Where it is running
- Children's Hospital of New Orleans — New Orleans, Louisiana, United States (enrolling)
Full record on ClinicalTrials.gov
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