The Efficacy and Safety of Lamotrigine Versus Carbamazepine in Focal Epilepsy

NCT05748236 | Unknown Phase 4 DMC

• 1 other identifier: ERC-DMC/ECC/2022/330
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Focal Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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

  6 month

Secondary Outcomes (5)

• Reduction of seizure frequency.

  6 month

• Duration of seizure free period.

  6 month

• Hospital readmission after receiving intervention

  6 month

• Rate of death among patients

  6 month

• Adverse drug reactions among two groups.

  6 month

Study Arms (2)

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)

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)

Drug: Carbamazepine-Containing Product in Oral Dose Form

Interventions

Lamotrigine tablet DRUG

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).

Also known as: Lamitrin, Lamogin

Lamotrigine

Carbamazepine-Containing Product in Oral Dose Form DRUG

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).

Also known as: Tegretol

Carbamazepine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dhaka Medical College: lead

Study Sites (1)

Dhaka medical college

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Lamotrigine; Carbamazepine; Dosage Forms

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Dr Mohammad Osman, MBBS

  MD Neurology Thesis

  PRINCIPAL INVESTIGATOR

• Kazi Gias Uddin Ahmed, MD

  Associate professor, Dhaka Medical College

  STUDY CHAIR

• Reaz mahmud

  Dhaka Medical College

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 28, 2023
• Study Start: November 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: october 2023 to september 2024
• Access Criteria: who work with focal epilepsy patients

Locations

BA (1)