Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies
Overview
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.
Full Title of Study: “An Open, Randomized, Multicenter Comparative Clinical Trial of Lamotrigine or Carbamazepine for Cognitive Function as Initial Monotherapy in Adult Untreated Epilepsies”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 2008
Interventions
- Drug: lamotrigine (Lamictal)
- lamotrigine: titration for 8 weeks (25 mg~200 mg per 2 weeks) and maintenance for 40 weeks (200 mg)
- Drug: Carbamazepine (Tegretol)
- Carbamazepine: titration for 8 weeks (100 mg~600 mg) and maintenance for 40 weeks (600 mg)
Arms, Groups and Cohorts
- Experimental: 1
- lamotrigine
- Active Comparator: 2
- carbamazepine
Clinical Trial Outcome Measures
Primary Measures
- To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients
- Time Frame: 48 weeks
Secondary Measures
- Seizure outcome and tolerability
- Time Frame: 48 weeks
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 16 Years
Maximum Age: 60 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Korean Epilepsy Society
- Collaborator
- GlaxoSmithKline
- Provider of Information About this Clinical Study
- Korean Epilepsy Society Chairman, Korean Epilepsy Society
- Overall Official(s)
- Sang-Ahm Lee, Professor, Principal Investigator, Asan Medical Center
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