NCT07284069RecruitingEarly phase 1
Senicapoc and Perampanel for Newly Diagnosed Glioblastoma
Phase 0/1 Randomized Clinical Trial of SENIcapoc and PERAmpanel Mono- and Combination Therapy of Newly Diagnosed Glioblastoma
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
Glioblastoma is the most common and aggressive form of brain cancer in adults. Despite surgery, radiotherapy, and chemotherapy, most patients only live about one year after diagnosis. There is an urgent need for new and better treatments. Recent research has shown that glioblastoma cancer cells communicate with surrounding brain cells through electrical signals that help the tumor grow and resist treatment. Two existing drugs, perampanel (used for epilepsy) and senicapoc (previously tested for blood disorders), may block these harmful signals. Laboratory studies suggest that combining these two drugs could slow tumor growth and make cancer cells more sensitive to standard therapy. The SENIPERA trial will test whether perampanel and senicapoc, alone and in combination, are safe and well tolerated when added to standard treatment for newly diagnosed glioblastoma. The study will also measure how well these drugs reach the brain and tumor, and how they affect tumor biology. The study has two parts: Part A: Tests different doses of senicapoc alone to find the maximum tolerable dose. Part B: Randomly assigns patients to receive either perampanel alone or perampanel together with senicapoc. Participants will all receive standard therapy, including surgery, radiochemotherapy, and adjuvant chemotherapy. During surgery, small samples of tumor and fluid will be collected safely to study how the drugs act in the body and how tumor cells respond. Participants will be closely monitored for side effects and followed with regular clinical visits and MRI scans. The trial will take place at Aarhus University Hospital, Denmark, from February 2026 to November 2028 and will enroll 27-36 adult patients. The study aims to identify safe and biologically active treatment combinations that could be tested in larger trials to improve future glioblastoma care.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- Mar 2026
- Primary completion date
- Nov 2028
- Lead sponsor
- Aarhus University Hospital
- Diseases
- Glioblastoma
- NCT number
- NCT07284069
- EU CT number
- 2025-522605-37-00
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 36
- From Mar 2026 to the primary completion date, Nov 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with or allergic reaction to perampanel or senicapoc.
- Concomitant intake of enzyme-inducing antiepileptic drugs (carbamazepine, phenytoin, phenobarbotal, or primidon).
Other illness
- Previous malignancy with completion of treatment within five years before inclusion, except for basal cell carcinoma.
- 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.).
Lab values
- Significant co-morbidities, i.e.
- Significant liver function impairment (ALAT \> 210 umol/L for men and \> 135 umol/L for women or total bilirubin \> 25 umol/L)
- Significant renal impairment (eGFR \< 60 mL)
- Coagulopathy (INR \> 1.8 or APTT \> 57s)
- Thrombocytopenia (platelet count \< 100 x 103/μL = 100 x 109/L)
- Neutropenia (ANC \< 1.5 x 103/μL = 1.5 x 109/L)
- Anemia (Hb \< 10 g/L = 6.0 mmol/l)
- Severe cognitive impairment.
Other
- Pregnancy or nursing. Fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy.
- Contraindications for senicapoc or perampanel treatment.
- Active participation in another therapeutic interventional clinical trial.
Who the study is looking for
- Age 18 years or older
- 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
- Eligibility for surgical resection and planned postoperative concomitant radiochemotherapy and adjuvant chemotherapy according to the Stupp regimen
- Eligible for safe postponement of surgery for 14 days from enrollment
- Life expectancy \> 3 months
- WHO Performance Status ≤ 2.
- Ability to provide written informed consent.
- Use of validated anti-conception for fertile female participants in concordance with guidelines provided by the Danish health and medicines authority.
- Signed written consent form.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Aalborg University Hospital, Department of Neurosurgery Coordinator of this site? Confirm its status | Gistrup | Denmark | Recruiting |
| Rigshospitalet, Department of Neurosurgery Coordinator of this site? Confirm its status | KBH Ø | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.