Clinical Trials Logo

Clinical Trial Summary

Epilepsy is a serious chronic brain disorder that has a tendency towards recurrent seizures. This affects millions of people throughout the world and brings a heavy socioeconomic burden. The treatment of focal epilepsy is more challenging. Selecting an appropriate antiepileptic drug (AED) remains difficult because the chosen drug must be effective, safe and tolerable. It is important to consider the safety and efficacy of an AED for monotherapy separately. The goal of AED therapy is to achieve seizure control with little or no adverse efects, improve the patient's quality of life and ensure patient satisfaction. Different AEDs can be used to treat focal seizures in adults. First line medication for treating focal seizures is carbamazepine (CBZ), but it has drawbacks such as adverse effects including Steven Johnson syndrome, drug interactions and blood dyscrasia. There is also genetic linkage that Steven-Johnson syndrome and toxic epidermal necrolysis with carbamazepine are more common in individuals of Asian descent who carry the HLA-B 1502 allele. Another 1st line drug is lamotrigine (LTG) , it has favourable side effect profile including less sedative effect, less cognitive impairment, less drug interactions and blood dyscrasia. It has an elimination half- life longer than 24 hour, so once daily dosing is possible and it is associated with good drug compliance. Because of its favorable pharmacokinetics and side effect profile, LTG may be preferred to CBZ for focal epileptic seizures. In a study showed that the seizure freedom rate at the end of 6 months was 65% in LTG group compared to 73% in CBZ group. 41% in CBZ group and 32% in LTG group had at least one adverse effects. Few trials have compared the effectiveness and safety of LTG with CBZ as monotherapy for focal seizures worldwide. By far, no study has yet been conducted addressing the issue of efficacy and safety between lamotrigine and carbamazepine among focal epilepsy patients in the context of Bangladeshi population. Since the usage of LTG is less common in Bangladesh, comparative study of efficacy and safety of LTG versus CBZ will be expected to give more confidence for the use of the drug. Considering this, the study aims to assess the safety and efficacy of carbamazepine and lamotrigine among focal epilepsy patients. This study finding have an implication in the treatment protocol which will be beneficial for the patients and physicians as well.


Clinical Trial Description

This prospective hospital based open label interventional study will be conducted in Dhaka Medical College Hospital, Dhaka after receiving approval of this protocol from ethical review committee of DMC. Patients who match the inclusion and exclusion criteria will be enrolled in the study by simple random sampling. A written informed consent will be taken from patients or from their legal attendants after describing the aim, purpose and procedure of the study. Focal epilepsy will be diagnosed according to the criteria of the Commission on Classification and Terminology of the International League against Epilepsy (2017). In this study patients will be divided into 2 groups on their antiepileptic medication. The screening procedure, randomization and drugs will be started at day 1. All the assessment will be completed at day 1 and will be considered as baseline. Randomization will be done at 1:1 into parallel group. Each group will include 34 patients. Group A will include focal epileptic patients on lamotrigine and group B will include focal epileptic patients on carbamazepine. A structured questionnaire will be completed by investigator from answers of participating patients or with the help of their legal attendants, to obtain information on demographic characteristics (age, gender, marital status, education, socioeconomic level etc) and outcome of drug intervention. The patients will maintain a diary during the whole period and ask to note down any seizure frequency with date, time, duration and adverse effects of drugs. During the data record keeping every patient will be evaluated initially by investigator and later independently evaluated by a consultant neurologist. Lamotrigine will be given at starting dose 25 mg once daily for 2 weeks, then 50 mg once daily for next 2 weeks and carbamazepine will be given at starting dose 100 mg twice daily for 2 weeks, then 200 mg twice daily for next 2 weeks. In both drugs dose will be increased until seizure control or side effects develop. Patients will be followed up at 1st month, 3rd month and 6th month after receiving medication and following outcome will be assessed: reduction of seizure frequency, seizure free period, hospital readmission, frequency of status epilepticus, all-cause mortality, adverse drug reactions. Patients will be followed up at epilepsy clinic / outpatient department (OPD) and those patients who fail to attend at epilepsy clinic / OPD, by telephonic interview. All the above information will be recorded in a data collection form consisting of relevant questionnaire. After completion, data analysis will be done by SPSS version 26 (Chicago, Illinois, USA). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05748236
Study type Interventional
Source Dhaka Medical College
Contact
Status Enrolling by invitation
Phase Phase 4
Start date November 1, 2022
Completion date October 2023

See also
  Status Clinical Trial Phase
Recruiting NCT02245061 - Cortical Excitability Assessment Using Paired Pulses N/A
Terminated NCT05081518 - A Study of Lu AG06466 in Participants With Treatment Resistant Focal Epilepsy Phase 1
Withdrawn NCT05481905 - ENACT: A Study of ENX-101 as Adjunctive Treatment in Patients With Focal Seizures Phase 2
Completed NCT02208492 - The Effects on Cognitive Function of Levetiracetam (Keppra®) Compared to Carbamazepine (Tegretol®, Carmazepine®) as Monotherapy for Children With Partial Seizure; A Multicentric Randomized Controlled Study Phase 4
Recruiting NCT04839601 - RNS System RESPONSE Study N/A
Completed NCT02898935 - Improvement of the Accuracy of Spatial Representation of Invasive Exploratory Electrodes in Focal Epilepsy
Terminated NCT01724918 - Lacosamide IV and EEG/EKG (LIVE) Study Phase 2
Completed NCT00855738 - A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice Phase 4
Recruiting NCT06309966 - Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy Phase 2/Phase 3
Not yet recruiting NCT06210022 - Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy
Completed NCT01311440 - Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy N/A
Terminated NCT03955432 - Long-term Cardiac Monitoring in Epilepsy N/A
Recruiting NCT06132893 - A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy Phase 2/Phase 3
Recruiting NCT05100771 - Optimized Volumetry in Radiology: Interest in Pediatric Brain MRI in the Exploration of Focal Epilepsy
Recruiting NCT04879433 - Prospective Open-label Evaluation of Cenobamate Adjunctive Treatment of Adults With Refractory Focal Epilepsy
Active, not recruiting NCT03916848 - Novel Network Analysis of Intracranial Stereoelectroencephalography N/A
Recruiting NCT05198882 - Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy Phase 1
Recruiting NCT05981755 - Breathing Rescue for SUDEP Prevention N/A
Recruiting NCT03457961 - Post-market Study of AMPA Receptor Antagonists for Epilepsy Patients in Hong Kong
Not yet recruiting NCT06443463 - Long-term Safety and Tolerability of BHV-7000 Phase 2