Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies
An Open, Randomized, Multicenter Comparative Clinical Trial of Lamotrigine or Carbamazepine for Cognitive Function as Initial Monotherapy in Adult Untreated Epilepsies
1 other identifier
interventional
121
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2006
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 11, 2009
CompletedFirst Posted
Study publicly available on registry
May 12, 2009
CompletedMay 12, 2009
May 1, 2009
2.6 years
May 11, 2009
May 11, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients
48 weeks
Secondary Outcomes (1)
Seizure outcome and tolerability
48 weeks
Study Arms (2)
1
EXPERIMENTALlamotrigine
2
ACTIVE COMPARATORcarbamazepine
Interventions
lamotrigine: titration for 8 weeks (25 mg\~200 mg per 2 weeks) and maintenance for 40 weeks (200 mg)
Carbamazepine: titration for 8 weeks (100 mg\~600 mg) and maintenance for 40 weeks (600 mg)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Korean Epilepsy Societylead
- GlaxoSmithKlinecollaborator
Study Sites (1)
Asan Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang-Ahm Lee, Professor
Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 11, 2009
First Posted
May 12, 2009
Study Start
May 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
May 12, 2009
Record last verified: 2009-05