EPILEPSY MedDRA version: 20.0 Level: LLT Classification code 10015046 Term: Epilepsy, unspecified System Organ Class: 100000004852
Conditions
Interventions
Trade Name: TEGRETOL - 200 MG COMPRESSE A RILASCIO MODIFICATO 30 COMPRESSE
Product Name: CARBAMAZEPINA
Product Code: CARBAMAZEPINA
Pharmaceutical Form: Tablet
INN or Proposed INN: CARBAMAZEPINA
Curren
Sponsors
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older; 2. Newly diagnosed previously untreated epilepsy, defined according to the ILAE definition (Fisher et al, 2014); 3. Having experienced focal seizures, defined according to the ILAE criteria (Commission, 1981); 4. Able to understand and comply with the study requirements and release a written informed consent. 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 187 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 187
Exclusion criteria
Exclusion criteria: 1. Age less than 18 years; 2. Having experienced primarily or secondarily generalized tonic and/or clonic seizures, or other (non-focal) seizure types; 3. Previous exposure to AEDs; 4. Requiring low or standard doses on account of individual needs; 5. Inability to understand the aims or modalities of the study; 6. Current pregnancy or planning to become pregnant during the study period (e.g. who are not post-menopausal, surgically sterile, or using inadequate birth control). A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; 7. Men unable to practice contraception for the duration of the treatment. 8. Poor compliance with assigned treatments; 9. Refusal to release written informed consent; 10. Patients cannot be enrolled in the study if the contraindications/warnings described in the SPC are met.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the proportion of patients receiving a low dose of an AED and remaining seizure-free is not inferior to the proportion of patients who remain seizure-free after receiving a standard dose of the same drug.;Secondary Objective: To demonstrate that the proportion of patients experiencing intolerable drug-related adverse events is lower with a low than a standard dose. To demonstrate that health-related quality of life (HRQOL) and satisfaction with treatment score higher with a low than a standard dose. To demonstrate that, on a societal perspective, the treatment of newly diagnosed epilepsy with low AED doses will translate into savings in terms of contacts with the National Health System (in- and outpatient visits, drug expenditures). ;Primary end point(s): The primary end-point is a treatment failure motivated by the need to change the assigned dose or the assigned drug for seizure relapse.;Timepoint(s) of evaluation of this end point: Anytime during the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints include: 1. Treatment failure motivated by intolerable drug-related adverse events; 2. HRQOL total score at 12 months; 3. Patient's satisfaction at 12 months; 4. Total cost of health care resources consumed for the management of epilepsy during the first 12 months of the study. ;Timepoint(s) of evaluation of this end point: The endpoint "Treatment failure motivated by intolerable drug-related adverse events" will be evaluated anytime during the study. The other secondary endpoint will be evaluated at 12 months. | — |
Countries
Italy
Contacts
Public ContactLABORATORIO MALATTIE NEUROLOGICHE
IRCCS Istituto di Ricerche Farmacologiche Mario Negri
Outcome results
None listed