Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03636958 |
| Other study ID # |
2018-13 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2021 |
| Est. completion date |
December 1, 2026 |
Study information
| Verified date |
June 2022 |
| Source |
Assistance Publique Hopitaux De Marseille |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Fundamental studies on glioma-associated epilepsies have shown that there is a major
dysregulation of glutamatergic systems involved in epileptogenesis and tumor growth.
Targeting this glutamatergic system seems particularly interesting from a physiopathological
point of view. Perampanel is a recent antiepileptic treatment with a novel mode of action
targeting AMPA glutamate receptors. It has been shown to be effective in patients with
drug-resistant epilepsies. He has demonstrated his tolerance in these patients. He has
obtained a marketing authorization and is therefore used in routine epileptology without
serious problems of tolerance being reported. It is neither an inducer nor an enzyme
inhibitor, avoiding the problems of interaction with chemotherapy and is used in a daily dose
facilitating compliance.
Therefore, there may be specific antiepileptic efficacy of perampanel in patients with
glioma. Nevertheless, the only current data is limited to a retrospective study of 12
patients.
The objective of this protocol is to evaluate the efficacy and safety of perampanel in
patients with glioma with drug-resistant epilepsy.
a prospective randomized study with two parallel arms: antiepileptic combination therapy with
perampanel and antiepileptic combination therapy without perampanel (free choice of the
practitioner). The main criterion of judgment will be the decrease of the monthly frequency
of crisis. Secondary endpoints will assess tolerance, efficacy on responder rate (at least
50% decrease in seizure frequency), seizure severity (secondary generalization, loss of
consciousness), and quality. patients' lives (quality of life questionnaires, side effects
and anxiety / depression). The duration of participation per patient will be 23 weeks (6
weeks of baseline, 5 weeks of titration and 12 weeks of maintenance). The recruitment period
will be 3 years. Investigators plan to recruit 120 patients.
In the context of no recommendation in the management of these patients, superior efficacy of
perampanel compared with other antiepileptic drugs is expected. This would allow targeted
treatment in this population and confirm the tolerance of this treatment in these patients.
Description:
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-associated epilepsies have shown that there is a
major dysregulation of glutamatergic systems involved in epileptogenesis (= perpetuation of
epileptic seizures) and tumor growth (Huberfeld and Vecht, 2016). Targeting this
glutamatergic system seems particularly interesting from a physiopathological point of view.
Perampanel is a recent antiepileptic treatment with a novel mode of action targeting AMPA
glutamate receptors. It has been shown to be effective in patients with drug-resistant
epilepsies. He has demonstrated his tolerance in these patients. He has obtained a marketing
authorization and is therefore used in routine epileptology without serious problems of
tolerance being reported. It is neither an inducer nor an enzyme inhibitor, avoiding the
problems of interaction with chemotherapy and is used in a daily dose facilitating
compliance.
Therefore, there may be specific antiepileptic efficacy of perampanel in patients with
glioma. Nevertheless, the only current data is limited to a retrospective study of 12
patients.
The objective of this protocol is to evaluate the efficacy and safety of perampanel in
patients with glioma with drug-resistant epilepsy.
The investigators want to perform a prospective randomized study with two parallel arms:
antiepileptic combination therapy with perampanel and antiepileptic combination therapy
without perampanel (free choice of the practitioner). The main criterion of judgment will be
the decrease of the monthly frequency of crisis. Secondary endpoints will assess tolerance,
efficacy on responder rate (at least 50% decrease in seizure frequency), seizure severity
(secondary generalization, loss of consciousness), and quality. patients' lives (quality of
life questionnaires, side effects and anxiety / depression). The duration of participation
per patient will be 23 weeks (6 weeks of baseline, 5 weeks of titration and 12 weeks of
maintenance). The recruitment period will be 3 years. The investigators plan to recruit 120
patients.
Expected benefits: In the context of no recommendation in the management of these patients,
the investigators hope to demonstrate superior efficacy of perampanel compared with other
antiepileptic drugs. This would allow targeted treatment in this population and confirm the
tolerance of this treatment in these patients.
