Recruiting
Phase 1
Phase 2

Methylprednisolone

Sponsor:

Louisiana State University Health Sciences Center in New Orleans

Code:

NCT04219995

Conditions

Intractable Epilepsy

Convulsive Seizures

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Interventions

methylprednisolone sodium succinate

Placebo

Study Details

Brief 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.

Conditions

Intractable Epilepsy

Convulsive Seizures

Study ID

NCT04219995

Start date

Feb 3, 2020

Status verified date

Feb, 2020

Completion date

Feb, 2021

Anticipated

Primary completion date

Feb, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

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

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

Exclusion Criteria:

1. Patients with history of the following diagnoses:

1. Traumatic brain injury
2. Tuberous sclerosis
3. Sturge Weber
4. Cortical dysplasia
2. Patients with known hereditary degenerative diseases as follows:

1. Adrenoleukodystrophy
2. Neuronal ceroid lipofuscinosis
3. Leigh Syndrome
4. Myoclonic epilepsy with ragged red fibers (MERRF)
5. Rett Syndrome
3. Patients with the following epilepsy syndromes

1. Infantile spasms
2. West Syndrome
3. Progressive myoclonic epilepsy
4. Dravet syndrome
5. Doose syndrome
6. Ohtahara syndrome
7. Rasmussen's encephalitis
4. Patients with the following metabolic disorders

1. Phenylketonuria
2. Maple syrup urine disease
3. Organic acidemias
4. Galactosemia
5. Peroxismal disorders (e.g. Zellwegers)
6. Lysosomal disorders
7. Urea cycle disorders
5. Patients with history of immunodeficiency
6. Patients with the following infections

1. HIV/AIDS
2. Active or latent TB
3. Active or suspected bacterial infection
4. Active, latent or suspected fungemia
5. Active or suspected parasitic infection
7. Patients with history of malignancy
8. Patients with history of or active myopathy
9. Patients with degenerative neuromuscular disorders
10. Patients with history of hypersensitivity or allergic reactions to corticosteroids
11. Patients with history of psychosis
12. Patients with diabetes mellitus
13. Pregnancy
14. Any underlying predisposition to gastrointestinal bleeding (peptic ulcer disease, gastritis, colitis)

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Interventional start

Patients who randomize to the interventional start arm will receive the study drug, methylprednisolone sodium succinate, in the first month of the study, followed by placebo in the cross-over phase of the study.

placebo comparator: Placebo start

Patients who randomize to the placebo start arm will receive placebo in the first month of the study, followed by the study drug, methylprednisolone sodium succinate, in the cross-over phase of the study.

Interventions

methylprednisolone sodium succinate

Methylprednisolone sodium succinate will be re-constituted in simple syrup in a concentration of 80mg/mL and will be administered orally at 20mg/kg (max 1000mg) for days 1, 2, and 3 of the intervention phase of the study.

Placebo

The placebo used in this study will be simple syrup.

Primary outcome measure

  • Seizure frequency [ Time Frame: The number of seizures per month will be assessed at 1 month (following placebo/intervention), 2 months (following wash-out), and 3 months (following cross-over phase of placebo/intervention). Change compared to baseline will be calculated. ]

Central Contacts and Locations

Central contacts

Xinran Maria Xiang, MD

5048969283xxiang@lsuhsc.edu

Locations

Children's Hospital of New Orleans

Recruiting

New Orleans, Louisiana, United States, 70118

Contacts

Xinran Xiang, MD

504-896-9283xxiang@lsuhsc.edu

Principal Investigator:

Jeremy Toler, MD

More Information

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Last update posted

Feb 7, 2020

Last verified

Feb, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Louisiana State University Health Sciences Center in New Orleans on 2020-02-07.