A study to investigate the safety of the drugs topiramate and levetiracetamin treating children recently diagnosed with epilepsy

Phase 1

• Conditions: ew-onset or recent-onset epilepsy.; MedDRA version: 20.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-001552-19-AT
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-04
• Study Completion: 2020-04-30
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

- Participant with a clinical diagnosis of new-onset or recent-onset
epilepsy characterized by partial-onset seizures (POS) (with or without
secondary generalization) or primary generalized tonic-clonic seizures
(PGTCS) in accordance with criteria of the International League Against
Epilepsy. The epilepsy diagnosis must be within the previous 2 years
before screening - Caregivers (parents or legally acceptable
representatives) of the participant must be able to accurately maintain
the participant take-home record and seizure diary
- At screening, participant must have weight and height values within
the 5th to 95th percentile for chronological age (based on standard Child
Height and Weight Charts from the Centers for Disease Control [CDC]) -
Participant must never have been treated for epilepsy (treatment-naïve)
or have been treated with no more than 1 standard antiepileptic drug
(AED) if temporary or urgent AED use was necessary. Previous AED exposure must not exceed either of the following: 1.)Thirty-one days immediately preceding enrollment, or 2.)A total of 6 months of previous AED exposure in the past if the AED has been discontinued for at least 1 year prior to enrollment - Parents (or legally acceptable representatives) of the participant must sign an informed consent/permission document, indicating that they understand the purpose of and procedures required for the study and are willing to give permission for their child to participate in the study. Participant 7 years of age and older, capable of understanding the nature of the study, must provide assent for their participation
Are the trial subjects under 18? yes
Number of subjects for this age range: 282
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Participant has a surgically implanted and functioning vagus nerve
stimulator - Participant has a history of seizures as a result of a
correctable medical condition, such as metabolic disturbance, toxic
exposure, neoplasm, or active infection within 2 weeks prior to the first
day of Screening - Participant has had uncontrolled seizures while
previously taking either topiramate or levetiracetam - Participant has a
history of non-epileptic seizures within 2 weeks prior to the first day of
Screening - Participant has myoclonic or absence seizures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified