Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies

Study Overview
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Brief Summary
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The purpose of this study is to compare the effect of anti-epileptic drugs' (AEDs) long-term treatment on cognitive function. This study is an open-label, randomized, multicenter comparative trial of lamotrigine versus carbamazepine. The planned enrollment is 100 patients.

Official Title
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An Open, Randomized, Multicenter Comparative Clinical Trial of Lamotrigine or Carbamazepine for Cognitive Function as Initial Monotherapy in Adult Untreated Epilepsies

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: lamotrigine (Lamictal)
* Drug: Carbamazepine (Tegretol)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age : 16 60 Seizure type was defined by MRI etc. Had more than 2 unprovoked seizures or 1 seizure with clear evidence for epilepsy (ex. positive in EEG or brain imaging) Need AED therapy and no AED medication for previous 1 year (exclude emergency medication for less than 2 weeks, baseline 4 weeks before) Is not pregnant by pregnancy test and is using contraceptive method Can report seizure diary by him/herself or his/her sick nurse Agreed to trial by written consent Exclusion Criteria: Follow-up loss Canceled agreement Added other medication due to aggravated disease in 24 weeks Diagnosed as IGE Has progressive CNS disease by MRI or EEG Has serious systemic or psychological disease Under IQ 70 Baseline lad data abnormality: Creatinine 2.0mg/dl or GOT/GPT 2 times higher than normal Abuse experience on alcohol or drugs Has experience on serious adverse event of any drug Previous experience on lamotrigine or carbamazepine Not suitable patients by investigator (uncooperative) Other reason which may interrupt the trial

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>lamotrigine | Drug: lamotrigine (Lamictal)<br>* lamotrigine: titration for 8 weeks (25 mg 200 mg per 2 weeks) and maintenance for 40 weeks (200 mg)<br>* Other names: lamictal;|
| Active Comparator: 2<br>carbamazepine | Drug: Carbamazepine (Tegretol)<br>* Carbamazepine: titration for 8 weeks (100 mg 600 mg) and maintenance for 40 weeks (600 mg)<br>* Other names: Tegretol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure outcome and tolerability |  | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, lamotrigine, cognitive function