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

Primary Purpose

Intractable Epilepsy, Convulsive Seizures

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
methylprednisolone sodium succinate
Placebo
Sponsored by
Louisiana State University Health Sciences Center in New Orleans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intractable Epilepsy

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Children's Hospital of New OrleansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Interventional start

Placebo start

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Seizure frequency
The percentage of patients with 50% or more reduction in seizure frequency.

Secondary Outcome Measures

Seizure freedom
The percentage of participants who become seizure free over 1 month
Adverse events
Percentage of participants who reports adverse events and the severity of the adverse events.
Drop out percentage
Percentage of participants who drop out of the study due to adverse events

Full Information

First Posted
January 2, 2020
Last Updated
February 5, 2020
Sponsor
Louisiana State University Health Sciences Center in New Orleans
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1. Study Identification

Unique Protocol Identification Number
NCT04219995
Brief Title
Pilot Trial to Evaluate The Effect of Oral Methylprednisolone on Seizure Frequency in Children With Epilepsy
Official Title
Pilot Randomized, Placebo-Controlled Trial to Evaluate The Effect of Oral Pulsed Methylprednisolone on Seizure Frequency in Pediatric Patients With Idiopathic Intractable Convulsive Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Louisiana State University Health Sciences Center in New Orleans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intractable Epilepsy, Convulsive Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional start
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo start
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
methylprednisolone sodium succinate
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo used in this study will be simple syrup.
Primary Outcome Measure Information:
Title
Seizure frequency
Description
The percentage of patients with 50% or more reduction in 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.
Secondary Outcome Measure Information:
Title
Seizure freedom
Description
The percentage of participants who become seizure free over 1 month
Time Frame
The number of seizures per month will be assessed at 1 month (following placebo/intervention), 2 months (following wash-out period), and 3 months (following cross-over phase of placebo/intervention).
Title
Adverse events
Description
Percentage of participants who reports adverse events and the severity of the adverse events.
Time Frame
Adverse events will be recorded at 1 month (following placebo/intervention), 2 months (following wash-out period), and 3 months (following cross-over phase of placebo/intervention).
Title
Drop out percentage
Description
Percentage of participants who drop out of the study due to adverse events
Time Frame
The number of participants who drop out will be counted and recorded at 1 month (following placebo/intervention), 2 months (following wash-out period), and 3 months (following cross-over phase of placebo/intervention).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) Lysosomal disorders Urea cycle disorders Patients with history of immunodeficiency Patients with the following infections HIV/AIDS Active or latent TB Active or suspected bacterial infection Active, latent or suspected fungemia Active or suspected parasitic infection Patients with history of malignancy Patients with history of or active myopathy Patients with degenerative neuromuscular disorders Patients with history of hypersensitivity or allergic reactions to corticosteroids Patients with history of psychosis Patients with diabetes mellitus Pregnancy Any underlying predisposition to gastrointestinal bleeding (peptic ulcer disease, gastritis, colitis)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinran Maria Xiang, MD
Phone
5048969283
Email
xxiang@lsuhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Toler, MD
Organizational Affiliation
Louisiana State University Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinran Xiang, MD
Phone
504-896-9283
Email
xxiang@lsuhsc.edu
First Name & Middle Initial & Last Name & Degree
Jeremy Toler, MD
First Name & Middle Initial & Last Name & Degree
Xinran Xiang, MD

12. IPD Sharing Statement

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

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