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

Intractable Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04219995
• Other study ID #: IRB# 19-179
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 3, 2020
• Est. completion date: February 2021

Study information

• Verified date: February 2020
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: Xinran Maria Xiang, MD
• Phone: 5048969283
• Email: xxiang[@]lsuhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Convulsive Seizures
• Drug Resistant Epilepsy
• Epilepsy
• Intractable Epilepsy
• Seizures

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital of New Orleans	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure frequency	The percentage of patients with 50% or more reduction in seizure frequency.	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	Seizure freedom	The percentage of participants who become seizure free over 1 month	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).
Secondary	Adverse events	Percentage of participants who reports adverse events and the severity of the adverse events.	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).
Secondary	Drop out percentage	Percentage of participants who drop out of the study due to adverse events	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).