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Clinical and translational controlled study of Perampanel treatment around Surgery in patients with progressive glioblastoma (PerSurge)
EU CTIS ID: 2023-503938-52-00
What this study is testing
The primary aim of the trial is to demonstrate the efficacy of pre-surgical perampanel compared to placebo treatment with respect to A) the shift of mRNA expression patterns to a lower connectivity score in tumour tissue, and B) the presurgical tumour growth rate as assessed by tumour volume [cm³] per a central blinded independent review committee (BIRC) based on AI-quantified MRI parameters (T2/FLAIRweighted images) in patients with recurrent/progressive glioblastoma willing to adhere to the randomised treatment and who will undergo surgery.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically confirmed glioblastoma, progressive or recurrent after 1 or 2 lines of prior treatment, involving one radiotherapy and drug treatments according to institutional standards or prior trial participation, >3 months after end of radiotherapy, and therapy for relapse not yet started.
- Cognitive state to understand rationale, necessity and individual consequences of study therapy and procedures.
- Female patients with reproductive potentiala must use an approved contraceptive method during and for 4 weeks after the end of trial medication (Pearl Index <1%)
- Female patients with reproductive potential: a negative serum pregnancy test (beta- HCG) must be obtained prior to treatment start.
- Indication for surgical resection of progressive or recurrent tumour tissue, with a safe waiting interval of up to 5 weeks.
- A sufficient amount of resected tumour tissue (minimum 0.5 cm3) is expected to be available for the trial-specific molecular, morphological, functional and perampanel level analysis.
You likely can't join if
- Participation in other ongoing interventional clinical trials.
- Concomitant intake of enzyme-inducing antiepileptic drugs (EIAEDs: carbamazepine, eslicarbazepine, oxcarbazepine, phenobarbital, phenytoin, primidon, rufinamid)
- Steroid intake of more than 4 mg dexamethasone (or equivalence dose) in the last week, or expected indication for it in the foreseeable future
- History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 2 years unless the patient has been disease-free for 2 years.
- Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the patient in this study.
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry.
See the full eligibility criteria
Who can join
- Histologically confirmed glioblastoma, progressive or recurrent after 1 or 2 lines of prior treatment, involving one radiotherapy and drug treatments according to institutional standards or prior trial participation, >3 months after end of radiotherapy, and therapy for relapse not yet started.
- Cognitive state to understand rationale, necessity and individual consequences of study therapy and procedures.
- Female patients with reproductive potentiala must use an approved contraceptive method during and for 4 weeks after the end of trial medication (Pearl Index <1%)
- Female patients with reproductive potential: a negative serum pregnancy test (beta- HCG) must be obtained prior to treatment start.
- Indication for surgical resection of progressive or recurrent tumour tissue, with a safe waiting interval of up to 5 weeks.
- A sufficient amount of resected tumour tissue (minimum 0.5 cm3) is expected to be available for the trial-specific molecular, morphological, functional and perampanel level analysis.
- Tumour progression according to RANO criteria
- Age ≥18 years
- Karnofsky Performance status score (KPS) ≥ 60%
- Life expectancy > 3 months
- Willing and able to comply with regular neurocognitive and health-related quality of life tests/questionnaires.
- Written informed consent
What rules you out
- Participation in other ongoing interventional clinical trials.
- Concomitant intake of enzyme-inducing antiepileptic drugs (EIAEDs: carbamazepine, eslicarbazepine, oxcarbazepine, phenobarbital, phenytoin, primidon, rufinamid)
- Steroid intake of more than 4 mg dexamethasone (or equivalence dose) in the last week, or expected indication for it in the foreseeable future
- History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 2 years unless the patient has been disease-free for 2 years.
- Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the patient in this study.
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry.
- Pregnancy or breastfeeding
- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
- The presence of any other concomitant severe, progressive, or uncontrolled renal, hepatic, haematological, endocrine, pulmonary, cardiac, or psychiatric disease, or signs or symptoms thereof, that may affect the subject’s participation in the study, according to investigators judgement.
- Inability to undergo contrast-enhanced MRI.
- Inability to undergo surgery (e.g. because of need for continuous anticoagulation, known bleeding disorders, thrombocytopenia <50/nl, pre-existing wound healing problems).
- Any continued or planned standard or experimental treatment for the tumour other than resection, including antiangiogenic therapy (such as Bevacizumab), and local therapy in addition to the planned resection, including BCNU wafers, loco-regional hyperthermia, tumour bed irradiation, and photodynamic therapy.
- Tumour carries a known mutation in the IDH1 or IDH2 gene
- Severe or significant abnormal (≥ Grade 3 CTCAE v5.0) laboratory values for haematology (Hb, WBC, neutrophils, or platelets), liver (serum bilirubin, ALT, or AST) or renal function (serum creatinine).
- Known active tuberculosis; HIV infection or active Hepatitis B (HBV) or Hepatitis C (HCV infection, or active infections requiring oral or intravenous antibiotics or that can cause a severe disease and pose a severe danger to lab personnel working on patients’ blood or tissue (e.g. rabies).
- Any prior treatment with perampanel
- Contraindication against treatment with perampanel
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.