Epilepsy or other diseases in which using: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, topiramate and valproate in mono or politerapy MedDRA version: 15.0 Level: SOC Classification code 10037175 Term: Psychiatric disorders System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 15.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: carbamazepina
CAS Number: 298-46-4
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 400-
Pharmaceu
Sponsors
IRCCS FONDAZIONE ISTITUTO NEUROLOGICO C. MONDINO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study will be conducted in adults of either gender fulfilling the following inclusion criteria: (i) 18 years of age or older; (ii) currently being treated and at steady-state with any product (brand or generic) of carbamazepine, valproic acid, topiramate, oxcarbazepine, levetiracetam and/or lamotrigine administered in two or three divided daily doses, either alone or in combination with other drugs; (iii) a diagnosis of epilepsy or any other condition justifying prescription of AED therapy; (iv) being admitted to hospital for observation/diagnostic evaluation; (v) expected to remain on the currently prescribed drug treatment for at least 5 days (or 6 days for patients receiving lamotrigine or topiramate without enzyme inducers, or receiving lamotrigine combined with enzyme inducers plus valproate) following admission to hospital; (vi) willingness to provide free, informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Exclusion criteria will be (i) a history of known or suspected poor compliance; (ii) recent changes in drug treatment, including potentially interacting comedication, which may have prevented attainment of steady-state conditions of the AED(s) being tested; (iii) known disorders of gastric motility; (iv) pregnancy or lactation; (v) any condition which is expected to alter the pharmacokinetics of the study drug(s) over the subsequent 5/6 days; (vi) inability to fully understand the nature and implications of the study. Subjects will be free to withdraw from the study at any time, or whenever the investigator considers their participation detrimental to their health.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to provide high-quality evidence on potential risks associated with substitution of the currently taken AED product (carbamazepine,valproic acid, topiramate, oxcarbazepine, levetiracetam or lamotrigine) with an equivalent product, using as endpoint changes in serum drug levels at steady-state after substitution compared with baseline.;Secondary Objective: Secondary objectives will be the assessment of inter-subject variability in serum drug concentration on an unchanged treatment schedule, and evaluation of potential short-term changes in seizure control and adverse events rate.;Primary end point(s): Proportion of patients who post-randomization show a greater than 25% change in serum drug concentration compared with baseline;Timepoint(s) of evaluation of this end point: 5-7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (i) Proportion of patients who post-randomization will show a greater than 15% change in mean serum drug concentration compared with baseline; (ii) proportion of patients who post-randomization will show a greater than 50% change in mean serum drug concentration compared with baseline; (iii) proportion of patients who will show a greater than 15, 25% and 50% change in either post-absorptive or trough serum drug concentration compared with baseline; (iv) distribution in individual serum drug concentrations post-randomization compared with baseline (v) mean percent change (and %CV) in serum drug concentration post-randomization compared with baseline; (vi) proportion of patients with adverse events; (vii) adverse event (AEP) scores; (viii) interval elapsed between randomization and the first seizure; (ix) the above outcome measures, by type of AED, specific product utilized, and type of switch (brand to generic and generic to generic).;Timepoint(s) of evaluation of this end point: 5-7 days | — |
Countries
Italy
Contacts
Public ContactClinical Trial Center
Fondazione Istituto Neurologico Nazionale C. Mondino
Outcome results
None listed