SEIZURE PROPHYLAXIS IN GLIOMAS (SPRING): A PHASE III RANDOMISED CONTROLLED TRIAL COMPARING PROPHYLACTIC LEVETIRACETAM VERSUS NO PROPHYLACTIC ANTI-EPILEPTIC DRUG IN GLIOMA SURGERY

Jenkinson, MD ORCID: 0000-0003-4587-2139, Watts, C, Marson, AG, Hill, R, Murray, K, Vale, L, Bulbeck, H and Grant, R (2019) SEIZURE PROPHYLAXIS IN GLIOMAS (SPRING): A PHASE III RANDOMISED CONTROLLED TRIAL COMPARING PROPHYLACTIC LEVETIRACETAM VERSUS NO PROPHYLACTIC ANTI-EPILEPTIC DRUG IN GLIOMA SURGERY. In: Joint SBNS - ABN meeting, 2018-9-19 - 2019-6-21, London.

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Official URL: http://dx.doi.org/10.1136/jnnp-2019-abn.25

Abstract

<jats:sec><jats:title>Objectives</jats:title><jats:p>There is no consensus regarding the need for prophylactic anti-epileptic drug (AED) in seizure-naive newly-diagnosed glioma patients. Data regarding prophylactic AED use are scant and inconclusive from older, small studies that enrolled patients with brain metastases, benign tumours and gliomas. A definitive randomised controlled trial (RCT) is needed to determine whether the policy of prophylactic AED therapy reduces the risk of first seizures in this population.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Multi-centre RCT.</jats:p></jats:sec><jats:sec><jats:title>Subjects</jats:title><jats:p>Inclusion criteria: i. seizure-naive, ii. supratentorial glioma suitable for surgery (biopsy/resection), iii. age ≥16 years; iv. Karnofsky performance status >60.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Patients are randomised 1:1. Levetiracetam 500 mg bd for 2 weeks, increased to 750 mg bd thereafter for 1 year. Non-blinded. No placebo. Primary Outcome: one year risk of first seizure. Secondary outcomes: time to first seizure, time to first tonic-clonic seizure, mood, fatigue, quality of life, progression free survival, overall survival and incremental cost per QALY. Estimate of 1 year seizure rate in glioma after surgery is 20%. Based on a reduction in seizure rate to 10% a total of 806 patients will be recruited.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Grant awarded by NIHR. Feasibility questionnaire demonstrated prophylactic AED rarely used. Neurosurgeons willing to randomise. 15 UK centres have expressed interest in participating.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>SPRING will establish class I evidence for the use of seizure prophylaxis in glioma surgery. The trial will open to recruitment in January 2019.</jats:p></jats:sec>

Item Type:	Conference or Workshop Item (Unspecified)
Uncontrolled Keywords:	Brain Cancer, Brain Disorders, Rare Diseases, Neurosciences, Prevention, Clinical Trials and Supportive Activities, Cancer, Neurodegenerative, Epilepsy, Clinical Research, 6.1 Pharmaceuticals, 6 Evaluation of treatments and therapeutic interventions, 3 Good Health and Well Being
Depositing User:	Symplectic Admin
Date Deposited:	28 Jun 2019 15:46
Last Modified:	15 Mar 2024 05:23
DOI:	10.1136/jnnp-2019-ABN.25
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3047785