PATIENTS WITH BRAIN TUMOR RELATED EPILEPSY MedDRA version: 14.1 Level: LLT Classification code 10068330 Term: Symptomatic epilepsy System Organ Class: 100000004852
Conditions
Interventions
Trade Name: VIMPAT
Pharmaceutical Form: Tablet
INN or Proposed INN: LACOSAMIDE
CAS Number: 175481-36-4
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 200-400
Sponsors
ISTITUTI FISIOTERAPICI OSPITALIERI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients Age =18 years =75 (both sexes) with primary BT (astrocytoma II and III WHO, oligodendroglioma II and III WHO and multiform glioblastoma), cerebral lymphoma, with previous surgical resection or biopsy. Informed consent signature Patients in a stable phase of disease (evidenced by unchanged neuroradiological examinations). Symptomatic epilepsy characterized by partial seizures with or without secondary generalization; = 2 seizure in the last month, despite treatment with the maximum tolerated stable dose of 1-2 AED. Seizure retrospective count at least in the last 28 days. Patients could be also in treatment with CT, radiotherapy and corticosteroids started before LCM introduction not generating specific adverse effects. Patients treated for the oncological disease following international oncological guidelines Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Patients Age =18 years =75 (both sexes) with primary BT Karnofsky Performace Status <60 Patients with a previous epilepsy before tumor onset Patients with other chronic neurological and psychiatric diseases Patients with brain metastases Patients child bearing or breastfeeding Allergy or intolerance to soya, peanuts, lacosamide, lacosamide tablet eccipients. Patients with known preexisting second or third degree AV block.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of LCM treatment on seizure control as add-on in patients with brain tumor-related epilepsy, after 6 months period of treatment. ;Secondary Objective: 1. Responder rate =50%, 75%, 100% 2. To monitor the impact on QoL, on mood and on functional status at 3 and 6 months as compared with baseline 3. To evaluate the possible modifications of blood levels of LCM 4. To evaluate the occurrence of adverse events during therapy with LCM using Adverse Events Profile (AEP) ;Primary end point(s): Mean seizure frequency reduction as compared with baseline period available during the 6 months of treatment period after having reached minimal effective dose of 200mg/day.;Timepoint(s) of evaluation of this end point: 6 MONTHS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Seizure freedom rate at 6 months of treatment period. Responder rate using a = 50% and 75% reduction of seizure frequency as compared with baseline. A patient responder is defined as a patient having achieved at least a 50% monthly seizure reduction during the six months of treatment as compared with seizure frequency at baseline. Seizure frequency will be evaluated as mean of the seizure frequency during the 6 months of the treatment period. Stability of blood levels of LCM during the follow-up. ;Timepoint(s) of evaluation of this end point: 3-6 MONTHS | — |
Countries
Italy
Contacts
Public ContactSEGRETERIA COMITATO ETICO
ISTITUTI FISIOTERAPICI OSPITALIERI
Outcome results
None listed