Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies
Information source: Korean Epilepsy Society
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: lamotrigine (Lamictal) (Drug); Carbamazepine (Tegretol) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Korean Epilepsy Society Official(s) and/or principal investigator(s): Sang-Ahm Lee, Professor, Principal Investigator, Affiliation: Asan Medical Center
Summary
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.
Clinical Details
Official title: An Open, Randomized, Multicenter Comparative Clinical Trial of Lamotrigine or Carbamazepine for Cognitive Function as Initial Monotherapy in Adult Untreated Epilepsies
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients
Secondary outcome: Seizure outcome and tolerability
Eligibility
Minimum age: 16 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Asan Medical Center, Seoul, Korea, Republic of
Additional Information
Starting date: May 2006
Last updated: May 11, 2009
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