Generic substitution of antiepileptic drugs

Conditions: Epilepsy or other diseases in which using: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, topiramate and valproate in mono or politerapy
MedDRA version: 15.0Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 15.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2012-001017-16-IT

Lead Sponsor: IRCCS FONDAZIONE ISTITUTO NEUROLOGICO C. MONDINO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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 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.