TTS (Time To Stop) Trial

Phase 1

Conditions: We will investigate possible cognitive benifits of early antiepileptic drug withdrawal after pediatric epilepsy surgery. The concerning medical condition is refractory epilepsy
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2011-005971-18-NL

Lead Sponsor: niversity Medical Center Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

•Younger than 16 years at surgery, with focal non-idiopathic epilepsy, with written informed consent of parents and children when older than 12 years old.
•Native speaker in the language the neuropsychological tests have to be taken
•Be able to perform the EpiTrack Junior preoperatively
•Underwent intentional curative epilepsy surgery
•After surgery, the treating physician considers withdrawal of AEDs, with the intention to completely discontinue medication, at whatever point in time.
•Both the treating physician, the patient, if capable, and the parents agree with randomization in either arm of the study
•Postoperative seizure freedom was achieved (with the exception of so called running down seizures not outlasting longer than two weeks)

Are the trial subjects under 18? yes
Number of subjects for this age range: 180
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

•A contraindication to be randomized to either of the two withdrawal arms
•The treating physician does not want to discontinue all AEDs within a maximum time frame of eight months as prescribed in the study protocol.
•Multifocal MRI abnormalities, incomplete resection of the anatomical or epileptogenic lesion certified before randomisation (if considered necessary by the treating physician by MRI) and, if a postoperative EEG is performed before randomisation, epileptic EEG abnormalities (these being the most important risk factors of seizure recurrence or unfavourable long-term seizure outcome).
•Use of more than 3 AEDs at time of surgery. The reason to choose for a maximum of 3 AEDs is that clinicians would not want to wait 12 months (the late withdrawal arm) to withdraw the first AED in patients that use so many AEDs. Furthermore, withdrawing AEDs within 8 months seems reasonable and feasible for a maximum of 3 AEDs.
•Patients who are on a ketogenic diet or have a vagal nerve stimulator implanted.
•If surgery is primarily intended as tumor surgery and not as epilepsy surgery