Epilepsy
Conditions
Interventions
Add clobazam as adjuvant drug in the treatment of patients diagnosed with focal epilepsy already using one or two antiepileptic drugs, but not controlled for seizures in a minimum sample of 40 patient
Drug
C10.228.140.490.360
D12.776.157.530.400.175.562
Sponsors
Universidade Federal de Pernambuco
Universidade Federal de Pernambuco
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Diagnosis of focal epilepsy according to ILAE classification; Focal epilepsy with at least 1 epileptic seizure every 2 months, in current use of monotherapy or polytherapy; Age above 18 years; Regularity and attendance at scheduled appointments.
Exclusion criteria
Exclusion criteria: Comorbidities such as severe kidney or liver disease that prevent the use of therapy proposed by the study; Use one of two study drugs, namely clobazam or clonazepam.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a reduction of 50% or greater in the frequency of epileptic seizures in the patients of the two study groups in the medical interview of the third postoperative month, using a simple percentage calculation, namely number of seizures before less nu number of seizures after divided by the number of seizures before ;To analyze the rate of intervention interruption in any patient in the two study groups after 3 months due to the emergence of significant and / or disabling adverse effects, lack of efficacy, or both | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the drug tolerability rate introduced to patients in the two study groups by the percentage calculation of drug discontinuation throughout the study | — |
Countries
Brazil
Contacts
Public ContactAline Rodrigues Maciel Lemos
Posneuro/UFPE
Outcome results
None listed