Intracranial meningioma and epilepsy Nervous System Diseases
Conditions
Interventions
Levetiracetam 250mg (IMP) or Placebo – Participant will take IMP/placebo twice a day (2 x 250mg capsules, morning and evening) for 14 days in total. Treatment will begin 24 hours prior to surgery (par
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to at least one seizure at 12 months post-surgery measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using patient records unless noted otherwise: 1. Time to first seizure 2. Time to first convulsive seizure 3. Time to first unprovoked seizure (seizure from day 8 onwards) 4. Driving under licence at 6 and 12 months 5. EQ-5D-5L at pre-surgery, 4-6 weeks post-surgery, 12 weeks post-surgery, 52 weeks post-surgery 6. Serious adverse reactions. Active monitoring of SARs will be from the period of randomisation until completion of IMP course, plus 1 week 7. Landriel Ibañez classification 30 days post-surgery | — |
Countries
England, United Kingdom
Contacts
Public ContactPriya Francis
Outcome results
None listed