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Clinical Trials/ISRCTN14381346
ISRCTN14381346
Active, not recruiting
Phase 3

Surgeons Trial Of Prophylaxis for Epilepsy in seizure naïve patients with Meningioma: a randomised controlled trial (STOP’EM)

niversity of Liverpool0 sites1,004 target enrollmentJune 22, 2023
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ConditionsIntracranial meningioma and epilepsyNervous System Diseases

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Intracranial meningioma and epilepsy
Sponsor
niversity of Liverpool
Enrollment
1004
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 22, 2023
End Date
September 30, 2027
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Liverpool

Eligibility 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

  • •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)

Outcomes

Primary Outcomes

Not specified

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