Efficacy and Safety of Perampanel in Combination in Glioma-refractory Epilepsy
Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · Aug 16, 2018
Trial Information
Current as of June 30, 2025
Withdrawn
Keywords
ClinConnect Summary
Background: Gliomas are primitive brain tumors frequently associated with epilepsy. In a significant number of these patients epilepsy is resistant to antiepileptic drugs. There are currently no recommendations for the management of these drug-resistant epilepsies associated with glioma. In addition, few studies have addressed the subject and no treatment appears to be superior to others in the literature for this indication. In addition, many antiepileptic drugs pose problems of tolerance or interaction with chemotherapy in these patients.
Rational: Fundamental studies on glioma-associate...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patient, male or female, over 18 years old
- • Glioma confirmed by histology
- • Not in progression (clinico-radiological criterion RANO, (Wen et al., 2014), see appendix 1)
- • No clinical worsening (excluding epileptic seizures)
- • No increase greater than 25% in contrast enhancement after gadolinium injection
- • No increase in the T2 / FLAIR hyper signal
- • Absence of new lesion
- • Diagnosis of drug-resistant epilepsy according to international epilepsy definitions (Fisher 2014 and Kwan 2010, see Appendices 2 and 3)
- • o Repeated epileptic seizures despite testing of two effective dose antiepileptic drugs tried at least 3 months
- • With at least 2 attacks per month (to ensure visibility on the duration of the study of the antiepileptic effect, see below)
- • Patient with epileptic seizures not limited to only subjective signs
- Exclusion Criteria:
- • Pregnant or lactating woman
- • Minor
- • Impossibility of signing consent
- • No affiliation to a social security scheme (beneficiary or beneficiary)
- • Person in emergency,
- • Person of legal age subject to a legal protection measure (major under guardianship, guardianship or court order), or unable to express his or her consent
- • Patient with at least 2 generalized tonic-clonic seizures per month.
About Assistance Publique Hopitaux De Marseille
Assistance Publique - Hôpitaux de Marseille (AP-HM) is a leading public healthcare institution in France, dedicated to providing high-quality medical care and advancing research in various clinical fields. As a prominent sponsor of clinical trials, AP-HM is committed to fostering innovation and improving patient outcomes through rigorous scientific investigation. With a multidisciplinary approach, the institution collaborates with a network of healthcare professionals, researchers, and academic partners to facilitate cutting-edge studies that address critical health challenges. AP-HM's dedication to ethical standards and patient safety underscores its role as a trusted leader in clinical research and healthcare delivery.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Marseille, Paca, France
Marseille, , France
Patients applied
Trial Officials
EMILIE GARRIDO PRADALIE
Study Director
APHM
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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