Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2025-12-26 @ 8:32 AM
Study NCT ID:
NCT04219995
Status:
UNKNOWN
Last Update Posted:
2020-02-07
First Post:
2020-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Trial to Evaluate The Effect of Oral Methylprednisolone on Seizure Frequency in Children With Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069279', 'term': 'Drug Resistant Epilepsy'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008776', 'term': 'Methylprednisolone Hemisuccinate'}], 'ancestors': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-05', 'studyFirstSubmitDate': '2020-01-02', 'studyFirstSubmitQcDate': '2020-01-03', 'lastUpdatePostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seizure frequency', 'timeFrame': '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.', 'description': 'The percentage of patients with 50% or more reduction in seizure frequency.'}], 'secondaryOutcomes': [{'measure': 'Seizure freedom', 'timeFrame': '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).', 'description': 'The percentage of participants who become seizure free over 1 month'}, {'measure': 'Adverse events', 'timeFrame': '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).', 'description': 'Percentage of participants who reports adverse events and the severity of the adverse events.'}, {'measure': 'Drop out percentage', 'timeFrame': '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).', 'description': 'Percentage of participants who drop out of the study due to adverse events'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intractable Epilepsy', 'Convulsive Seizures']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients age 2 -18 years of age\n2. 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\n\n a. Epilepsy diagnosed by historical clinical evidence\n3. Family's ability to understand and willingness to sign a written informed consent document for patients under 18.\n4. Willingness to complete seizure diary for duration of study\n5. Willingness to present to all study visits\n\nExclusion Criteria:\n\n1. Patients with history of the following diagnoses:\n\n 1. Traumatic brain injury\n 2. Tuberous sclerosis\n 3. Sturge Weber\n 4. Cortical dysplasia\n2. Patients with known hereditary degenerative diseases as follows:\n\n 1. Adrenoleukodystrophy\n 2. Neuronal ceroid lipofuscinosis\n 3. Leigh Syndrome\n 4. Myoclonic epilepsy with ragged red fibers (MERRF)\n 5. Rett Syndrome\n3. Patients with the following epilepsy syndromes\n\n 1. Infantile spasms\n 2. West Syndrome\n 3. Progressive myoclonic epilepsy\n 4. Dravet syndrome\n 5. Doose syndrome\n 6. Ohtahara syndrome\n 7. Rasmussen's encephalitis\n4. Patients with the following metabolic disorders\n\n 1. Phenylketonuria\n 2. Maple syrup urine disease\n 3. Organic acidemias\n 4. Galactosemia\n 5. Peroxismal disorders (e.g. Zellwegers)\n 6. Lysosomal disorders\n 7. Urea cycle disorders\n5. Patients with history of immunodeficiency\n6. Patients with the following infections\n\n 1. HIV/AIDS\n 2. Active or latent TB\n 3. Active or suspected bacterial infection\n 4. Active, latent or suspected fungemia\n 5. Active or suspected parasitic infection\n7. Patients with history of malignancy\n8. Patients with history of or active myopathy\n9. Patients with degenerative neuromuscular disorders\n10. Patients with history of hypersensitivity or allergic reactions to corticosteroids\n11. Patients with history of psychosis\n12. Patients with diabetes mellitus\n13. Pregnancy\n14. Any underlying predisposition to gastrointestinal bleeding (peptic ulcer disease, gastritis, colitis)"}, 'identificationModule': {'nctId': 'NCT04219995', 'briefTitle': 'Pilot Trial to Evaluate The Effect of Oral Methylprednisolone on Seizure Frequency in Children With Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Louisiana State University Health Sciences Center in New Orleans'}, 'officialTitle': 'Pilot Randomized, Placebo-Controlled Trial to Evaluate The Effect of Oral Pulsed Methylprednisolone on Seizure Frequency in Pediatric Patients With Idiopathic Intractable Convulsive Epilepsy', 'orgStudyIdInfo': {'id': 'IRB# 19-179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional start', '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.', 'interventionNames': ['Drug: methylprednisolone sodium succinate', 'Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo start', '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.', 'interventionNames': ['Drug: methylprednisolone sodium succinate', 'Other: Placebo']}], 'interventions': [{'name': 'methylprednisolone sodium succinate', 'type': 'DRUG', '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.', 'armGroupLabels': ['Interventional start', 'Placebo start']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'The placebo used in this study will be simple syrup.', 'armGroupLabels': ['Interventional start', 'Placebo start']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70118', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Xinran Xiang, MD', 'role': 'CONTACT', 'email': 'xxiang@lsuhsc.edu', 'phone': '504-896-9283'}, {'name': 'Jeremy Toler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xinran Xiang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Children's Hospital of New Orleans", 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'centralContacts': [{'name': 'Xinran Maria Xiang, MD', 'role': 'CONTACT', 'email': 'xxiang@lsuhsc.edu', 'phone': '5048969283'}], 'overallOfficials': [{'name': 'Jeremy Toler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Louisiana State University Health Sciences Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Louisiana State University Health Sciences Center in New Orleans', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}