Back to resultsLamotrigine Cognitive Function Study in Adult Untreated Epilepsies
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
lamotrigine (Lamictal)
Carbamazepine (Tegretol)
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, lamotrigine, cognitive function
Eligibility 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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
lamotrigine
carbamazepine
Outcomes
Primary Outcome Measures
To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients
Secondary Outcome Measures
Seizure outcome and tolerability
Full Information
NCT ID
NCT00896987
First Posted
May 11, 2009
Last Updated
May 11, 2009
Sponsor
Korean Epilepsy Society
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00896987
Brief Title
Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies
Official Title
An Open, Randomized, Multicenter Comparative Clinical Trial of Lamotrigine or Carbamazepine for Cognitive Function as Initial Monotherapy in Adult Untreated Epilepsies
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Korean Epilepsy Society
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, lamotrigine, cognitive function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
lamotrigine
Arm Title
2
Arm Type
Active Comparator
Arm Description
carbamazepine
Intervention Type
Drug
Intervention Name(s)
lamotrigine (Lamictal)
Other Intervention Name(s)
lamictal
Intervention Description
lamotrigine: titration for 8 weeks (25 mg~200 mg per 2 weeks) and maintenance for 40 weeks (200 mg)
Intervention Type
Drug
Intervention Name(s)
Carbamazepine (Tegretol)
Other Intervention Name(s)
Tegretol
Intervention Description
Carbamazepine: titration for 8 weeks (100 mg~600 mg) and maintenance for 40 weeks (600 mg)
Primary Outcome Measure Information:
Title
To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Seizure outcome and tolerability
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Ahm Lee, Professor
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies
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