Focal EpilepsyPhase 4NCT05748236
The Efficacy and Safety of Lamotrigine Versus Carbamazepine in Focal Epilepsy
A Phase 4 study testing Lamotrigine tablet and Carbamazepine-Containing Product in Oral Dose Form in people with Focal Epilepsy, run by Dhaka Medical College at 1 site in Bangladesh.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Epilepsy
- What is being tested?
- Lamotrigine tablet and Carbamazepine-Containing Product in Oral Dose Form
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Nov 2022to Oct 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years regardless of gender.
- Newly diagnosed focal epilepsy patient with or without secondary generalization.
- Relapse following antiepileptic drug withdrawal or failure on treatment other than lamotrigine or carbamazepine.
- Willing to participate and give informed written consent.
Who cannot join
- Patient with generalized seizure.
- Cryptogenic or unknown onset seizure.
- Known hypersensitivity to medication.
- History of drug abuse.
- Patient with serious medical conditions such as cardiovascular diseases, hepatic failure, renal failure, malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Lamotrigine Versus Carbamazepine in Focal Epilepsy: A Randomized, Open Label Clinical Trial in Dhaka Medical College Hospital
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.
Read the detailed 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).
- Conditions
- Focal Epilepsy
- Being tested
- Lamotrigine tablet, Carbamazepine-Containing Product in Oral Dose Form
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamotrigine tabletDrug
Also called Lamitrin, Lamogin
Lamotrigine: Starting dose 25mg once daily for 2 weeks, then 50 mg once daily for next 2 weeks . Then dose will be increased until seizure control or side effects develop (Maximum 500 mg/day).
Carbamazepine-Containing Product in Oral Dose FormDrug
Also called Tegretol
Starting dose 100mg twice daily for 2 weeks, then 200 mg twice daily for next 2 weeks. Then dose will be increased until seizure control or side effects develop (Maximum 1600 mg/day).
| Study group | Role | What they receive |
|---|---|---|
| Lamotrigine | Active comparator | Starting dose 25mg once daily for 2 weeks, then 50 mg once daily for next 2 weeks . Then dose will be increased until seizure control or side effects develop (Maximum 500 mg/day) Receives: Drug: Lamotrigine tablet |
| Carbamazepine | Active comparator | Starting dose 100mg twice daily for 2 weeks, then 200 mg twice daily for next 2 weeks. Then dose will be increased until seizure control or side effects develop (Maximum 1600 mg/day) Receives: Drug: Carbamazepine-Containing Product in Oral Dose Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy and safety between lamotrigine and carbamazepine among focal epilepsy patients.
The measurement of a medicine desired effect under ideal conditions, such as clinical trial (European medicine agency). It is measured as treatment retention rate at the end of follow up and percentage in reduction of seizure frequency from the time of drug initiation
Measured: 6 month
Secondary outcomes (5)
Reduction of seizure frequency.
The frequency of seizure was calculated as the number of seizure events before initial visit and at every follow up visit. The difference of seizure frequency was calculated by subtracting number of events from the previous value. In epilepsy clinic patients are asked to maintain a diary of seizure events with date, time and duration which are kept written in patient record form.
Measured: 6 month
Duration of seizure free period.
It will be evaluated as percentage of patients who are seizure free at the end of follow up period.
Measured: 6 month
Hospital readmission after receiving intervention
In previously admitted patient, is there any readmission?
Measured: 6 month
Rate of death among patients
Death during study period
Measured: 6 month
Adverse drug reactions among two groups.
Any noxious, unintended and undesired effect (including an abnormal laboratory finding) of a drug which occurs at a dose used in humans for prophylactic, diagnostic or therapeutic purpose (WHO).
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Nov 2022
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dhaka Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Reaz Mahmud, Dhaka Medical College
- Investigators
- Dr Mohammad Osman, MBBS, Principal investigator, MD Neurology ThesisKazi Gias Uddin Ahmed, MD, Study chair, Associate professor, Dhaka Medical CollegeReaz mahmud, Study director, Dhaka Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748236
- Sponsor's protocol ID
- ERC-DMC/ECC/2022/330
- Status last verified
- Oct 2023
- First submitted
- 7 Feb 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: demographic variables, primary and secondary outcomes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Lamotrigine Versus Carbamazepine in Focal Epilepsy: A Randomized, Open Label Clinical Trial in Dhaka Medical College Hospital
- ClinicalTrials.gov ID
- NCT05748236
- Acronym / sponsor ID
- ERC-DMC/ECC/2022/330
- Conditions
- Focal Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dhaka Medical CollegeUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lamotrigine | Active comparator | Drug: Lamotrigine tabletStarting dose 25mg once daily for 2 weeks, then 50 mg once daily for next 2 weeks . Then dose will be increased until seizure control or side effects develop (Maximum 500 mg/day) |
| Carbamazepine | Active comparator | Drug: Carbamazepine-Containing Product in Oral Dose FormStarting dose 100mg twice daily for 2 weeks, then 200 mg twice daily for next 2 weeks. Then dose will be increased until seizure control or side effects develop (Maximum 1600 mg/day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years regardless of gender.
- Newly diagnosed focal epilepsy patient with or without secondary generalization.
- Relapse following antiepileptic drug withdrawal or failure on treatment other than lamotrigine or carbamazepine.
- Willing to participate and give informed written consent.
Key exclusion criteria (5 listed)
- Patient with generalized seizure.
- Cryptogenic or unknown onset seizure.
- Known hypersensitivity to medication.
- History of drug abuse.
- Patient with serious medical conditions such as cardiovascular diseases, hepatic failure, renal failure, malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lamotrigine tabletAlso: Lamitrin, LamoginLamotrigine: Starting dose 25mg once daily for 2 weeks, then 50 mg once daily for next 2 weeks . Then dose will be increased until seizure control or side effects develop (Maximum 500 mg/day). | Drug | Lamotrigine |
| Carbamazepine-Containing Product in Oral Dose FormAlso: TegretolStarting dose 100mg twice daily for 2 weeks, then 200 mg twice daily for next 2 weeks. Then dose will be increased until seizure control or side effects develop (Maximum 1600 mg/day). | Drug | Carbamazepine |
Primary outcome
The efficacy and safety between lamotrigine and carbamazepine among focal epilepsy patients.
Time frame: 6 month
The measurement of a medicine desired effect under ideal conditions, such as clinical trial (European medicine agency). It is measured as treatment retention rate at the end of follow up and percentage in reduction of seizure frequency from the time of drug initiation
5 secondary outcomes
Reduction of seizure frequency.
Time frame: 6 month
Duration of seizure free period.
Time frame: 6 month
Hospital readmission after receiving intervention
Time frame: 6 month
Rate of death among patients
Time frame: 6 month
Adverse drug reactions among two groups.
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Yes. demographic variables, primary and secondary outcomes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Mohammad Osman, MBBS principal investigator
MD Neurology Thesis
Kazi Gias Uddin Ahmed, MD study chair
Associate professor, Dhaka Medical College
Reaz mahmud study director
Dhaka Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lamotrigine tablet and Carbamazepine-Containing Product in Oral Dose Form in people with Focal Epilepsy, run by Dhaka Medical College at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy and safety between lamotrigine and carbamazepine among focal epilepsy patients. (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.