Perampanel for the prevention of glioma associated seizures – efficacy and safety

Phase 2

• Conditions: Tumour associated epilepsy; Glioma; Neurological - Epilepsy; Cancer - Brain

• Registration Number: ACTRN12617000073303
• Lead Sponsor: Melbourne Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-13
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Pre-operative phase (ie inclusion for 7T MRI)
1. 18 – 80 years
2. Radiological diagnosis of a supratentorial WHO grade II-III glioma
3. Planned surgical resection or biopsy of lesion
4. 3T MRI performed as clinical standard of care
5. Able to give informed consent
6. No pre-operative seizure

Post-operative phase (ie inclusion for treatment intervention)
1. 18-80 years
2. Diagnosis of WHO grade II-III glioma
3. Less than 3 weeks from date of glioma resection or biopsy
4. No seizures prior to randomisation

Exclusion Criteria

1. Previous non-tumour related neurosurgical procedures (excluding biopsy of glioma)
2. Pre-operative chemotherapy or radiotherapy
3. Receiving >1000mg daily of levetiracetam or multiple concurrent anti-epileptic drugs at time of randomization
4. Contraindication to 7T MRI
5. Significant risk factors for non-tumour associated epilepsy
- Previously diagnosed epilepsy (excluding benign childhood epilepsies)
- Additional epileptogenic intra-cranial pathology (including intra-cranial complications from glioma resection)
6. History of major psychiatric morbidity (such as psychiatric illness requiring hospitalisation or history of psychosis, major depression or suicidality) within the last 2 years
7. Pregnant or breast-feeding
8. Excessive alcohol or recreational drug use

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first seizure after escalation phase (weeks 5-52) - assessed by seizure diary[52 weeks after randomization];Proportion of patients seizure free during 12 weeks efficacy assessment phase - assessed by seizure diary[16 weeks after randomization]