Does giving an anti-epileptic drug before surgery help prevent seizures in patients with glioma (a type of brain tumour) who have not previously had a seizure?

Phase 3

Completed

• Conditions: Glioma; Cancer

• Registration Number: ISRCTN70051203
• Lead Sponsor: Public Health Scotland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-02
• Study Completion: 2023-11-02
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

Patients:
1. Patients with suspected cerebral glioma on MRI or CT
2. Capable of giving informed consent
3. Patients must be =16 years old
4. Patients must have a Karnofsky performance status of >60
5. Patients must be able to safely swallow pills
6. Planned surgery for presumed glioma (biopsy or resection)

Carers:
Capable of giving informed consent

Exclusion Criteria

Patients:
1. Pregnant
2. History of any type of seizure for at least 10 years prior to randomisation
3. Known Severe Chronic Kidney Disease (CKD4 - eGRR <30 ml/min)
4. Concomitant methotrexate
5. Concomitant Anti-Epileptic Drug (including use for other reasons (e.g. pain))
6. Concomitant Benzodiazepines
7. Hypersensitivity to Levetiracetam

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of patients developing seizures measured using two-sided type I error level of 5% at 1 year