Investigating the use of levetiracetam to prevent seizures after brain surgery.

Phase 1

• Conditions: Seizures in patients with suspected cerebral glioma; MedDRA version: 20.0Level: PTClassification code 10018338Term: GliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 20.0Level: LLTClassification code 10061030Term: Brain tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2018-001312-30-GB
• Lead Sponsor: Common Services Agency

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-16
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 804

Inclusion Criteria

1)Patients with suspected cerebral glioma on MRI
?2)Capable of giving informed consent
?3)Patients must be = 16 years old
?4)Patients must have a Karnofsky performance status =70
?5)Patients must be able to safely swallow pills
6)Planned surgery for presumed glioma (biopsy or resection)

Are the trial subjects under 18? yes
Number of subjects for this age range: 8
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 474
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 322

Exclusion Criteria

1)Pregnant
2)History of any type of seizure for at least 10 years prior to randomisation ?3)Known Severe Chronic Kidney Disease (CKD4 - eGFR < 30ml/min)
4)Concomitant methotrexate
5)Concomitant AED (including use for other reasons (e.g. pain))
6)Concomitant benzodiazepines
7)Hypersensitivity to levetiracetam

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified