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

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ClinicalTrials.gov Identifier: NCT04219995
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Louisiana State University Health Sciences Center in New Orleans

Tracking Information
First Submitted Date  ICMJE January 2, 2020
First Posted Date  ICMJE January 7, 2020
Last Update Posted Date February 7, 2020
Actual Study Start Date  ICMJE February 3, 2020
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2020)
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. ]
The percentage of patients with 50% or more reduction in seizure frequency.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2020)
  • Seizure freedom [ 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). ]
    The percentage of participants who become seizure free over 1 month
  • 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). ]
    Percentage of participants who reports adverse events and the severity of the adverse events.
  • Drop out percentage [ 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). ]
    Percentage of participants who drop out of the study due to adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Trial to Evaluate The Effect of Oral Methylprednisolone on Seizure Frequency in Children With Epilepsy
Official Title  ICMJE Pilot Randomized, Placebo-Controlled Trial to Evaluate The Effect of Oral Pulsed Methylprednisolone on Seizure Frequency in Pediatric Patients With Idiopathic Intractable Convulsive Epilepsy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Intractable Epilepsy
  • Convulsive Seizures
Intervention  ICMJE
  • Drug: 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.
  • Other: Placebo
    The placebo used in this study will be simple syrup.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: methylprednisolone sodium succinate
    • Other: Placebo
  • 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:
    • Drug: methylprednisolone sodium succinate
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 3, 2020)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xinran Maria Xiang, MD 5048969283 xxiang@lsuhsc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04219995
Other Study ID Numbers  ICMJE IRB# 19-179
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Louisiana State University Health Sciences Center in New Orleans
Study Sponsor  ICMJE Louisiana State University Health Sciences Center in New Orleans
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeremy Toler, MD Louisiana State University Health Sciences Center
PRS Account Louisiana State University Health Sciences Center in New Orleans
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP