A trial to prevent epilepsy in people having surgery for a meningioma brain tumour

Phase 3

• Conditions: Intracranial meningioma and epilepsy; Nervous System Diseases

• Registration Number: ISRCTN14381346
• Lead Sponsor: niversity of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-22
• Last Update Posted: 12 August 2024
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1004

Inclusion Criteria

1. Newly-diagnosed meningioma on MRI
2. Seizure-naïve at presentation
3. Surgical resection of meningioma planned
4. Age =16 years
5. Written and informed consent

Exclusion Criteria

1. Posterior fossa meningioma
2. Previous history of epilepsy
3. Previous history of provoked seizures
4. Previous cranial neurosurgery for any cause
5. Renal failure (Chronic Kidney Disease [CKD] 4-5)
6. Use of anti-epileptic drug for another indication (e.g. trigeminal neuralgia) within 7 days preceding randomisation
7. Known hypersensitivity to levetiracetam, other pyrrolidone derivatives or any of the excipients
8. Actively breastfeeding
9. Weigh below 50kg (if aged 16 or 17 years)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to at least one seizure at 12 months post-surgery measured using patient records

Secondary Outcome Measures

Name	Time	Method
Measured using patient records unless noted otherwise:<br>1. Time to first seizure<br>2. Time to first convulsive seizure<br>3. Time to first unprovoked seizure (seizure from day 8 onwards)<br>4. Driving under licence at 6 and 12 months<br>5. EQ-5D-5L at pre-surgery, 4-6 weeks post-surgery, 12 weeks post-surgery, 52 weeks post-surgery <br>6. Serious adverse reactions. Active monitoring of SARs will be from the period of randomisation until completion of IMP course, plus 1 week<br>7. Landriel Ibañez classification 30 days post-surgery