Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2025-12-24 @ 2:20 PM
NCT ID:
NCT04219995
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
18 Years
Study:
NCT04219995
Study Brief:
Protocol Section:
NCT04219995