Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT07284069
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 years or older
2. Presumed GBM as determined by an expert multidisciplinary neuro-oncological tumor board, including participants from neurosurgery, neuro-oncology, neurology, and neuroradiology. The assessment should be based on a whole-brain MRI according to the consensus recommendations for a standardized brain tumor imaging protocol in clinical trials, not older than 4 weeks from the assessment
3. Eligibility for surgical resection and planned postoperative concomitant radiochemotherapy and adjuvant chemotherapy according to the Stupp regimen
4. Eligible for safe postponement of surgery for 14 days from enrollment
5. Life expectancy \> 3 months
6. WHO Performance Status ≤ 2.
7. Ability to provide written informed consent.
8. Use of validated anti-conception for fertile female participants in concordance with guidelines provided by the Danish health and medicines authority.
9. Signed written consent form.
Exclusion Criteria:
1. Pregnancy or nursing. Fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy.
2. Previous treatment with or allergic reaction to perampanel or senicapoc.
3. Contraindications for senicapoc or perampanel treatment.
4. Previous malignancy with completion of treatment within five years before inclusion, except for basal cell carcinoma.
5. Concomitant intake of enzyme-inducing antiepileptic drugs (carbamazepine, phenytoin, phenobarbotal, or primidon).
6. Significant co-morbidities, i.e.
1. Significant liver function impairment (ALAT \> 210 umol/L for men and \> 135 umol/L for women or total bilirubin \> 25 umol/L)
2. Significant renal impairment (eGFR \< 60 mL)
3. Coagulopathy (INR \> 1.8 or APTT \> 57s)
4. Thrombocytopenia (platelet count \< 100 x 103/μL = 100 x 109/L)
5. Neutropenia (ANC \< 1.5 x 103/μL = 1.5 x 109/L)
6. Anemia (Hb \< 10 g/L = 6.0 mmol/l)
7. Severe cognitive impairment.
7. Active participation in another therapeutic interventional clinical trial.
8. Any condition that might affect the absorption, distribution, metabolism, or excretion of the trial drugs (including malabsorption states as Whipple's disease, short bowel syndrome, etc.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07284069
Study Brief:
Protocol Section:
NCT07284069