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Closed (no longer recruiting)Last updated: 30 January 2024

PEGASUS-1: This phase II trial is evaluating an anti-epileptic drug as a way of controlling seizures in patients being treated for grade II-III gliomasPerampanel for the control of glioma associated seizures - efficacy and safety: a pilot phase II randomised controlled trial

Clinical summary

Summary

This is a randomised clinical trial, in which patients, will be post-operatively randomised to receive either perampanel or levetiracetam for 52 weeks.

Conditions

This trial is treating patients with grade II-III gliomas.

Cancer

Brain and Spinal Cancers Brain and Spinal

Age

People18 - 65

Phase

II

Trial Acronym

PEGASUS-1

More information

Trial Identifiers

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Trial sponsor

Royal Melbourne Hospital

Scientific Title

Perampanel for the control of glioma associated seizures - efficacy and safety: a pilot phase II randomised controlled trial

Eligibility

Inclusion

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. Experienced a pre-operative seizure attributed to glioma

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. Experienced a pre-operative seizure attributed to glioma

Exclusion

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

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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