Actively Recruiting
Senicapoc and Perampanel for Newly Diagnosed Glioblastoma
Led by Aarhus University Hospital · Updated on 2026-05-07
36
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
A
Aarhus University Hospital
Lead Sponsor
U
University of Aarhus
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Senicapoc and Perampanel for Newly Diagnosed Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Presumed glioblastoma confirmed by multidisciplinary tumor board based on MRI within 4 weeks
- Eligible for surgical tumor removal followed by radiochemotherapy and chemotherapy per Stupp regimen
- Surgery can be safely delayed for 14 days after enrollment
- Expected to live more than 3 months
- WHO Performance Status 0 to 2
- Able to provide written informed consent
- Fertile females must use validated contraception as per Danish health guidelines
- Signed written consent form
You will not qualify if you...
- Pregnancy or nursing; fertile females must have a negative pregnancy test
- Previous treatment with or allergy to perampanel or senicapoc
- Contraindications to senicapoc or perampanel
- Previous cancer treated within 5 years except basal cell carcinoma
- Taking enzyme-inducing antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, primidon)
- Significant liver impairment (ALAT >210 umol/L men, >135 umol/L women) or total bilirubin >25 umol/L
- Significant kidney impairment (eGFR < 60 mL)
- Blood clotting disorders (INR >1.8 or APTT >57s)
- Low platelets (platelet count <100 x 10^9/L)
- Low neutrophils (ANC <1.5 x 10^9/L)
- Low hemoglobin (Hb <10 g/L)
- Severe cognitive impairment
- Currently in another therapeutic interventional clinical trial
- Conditions affecting drug absorption, distribution, metabolism, or excretion such as malabsorption syndromes
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Trial Site Locations
Total: 1 location
1
Aarhus University Hospital, Department of Neurosurgery
Aarhus, Denmark, Denmark, 8200
Actively Recruiting
Research Team
A
Anders R Korshoej, MD, PhD, Associate professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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