EpilepsyPhase 4NCT00896987
Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies
A Phase 4 study testing lamotrigine (Lamictal) and Carbamazepine (Tegretol) in people with Epilepsy, run by Korean Epilepsy Society at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- lamotrigine (Lamictal) and Carbamazepine (Tegretol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2006to Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Randomized, Multicenter Comparative Clinical Trial of Lamotrigine or Carbamazepine for Cognitive Function as Initial Monotherapy in Adult Untreated Epilepsies
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.
- Conditions
- Epilepsy
- Being tested
- lamotrigine (Lamictal), Carbamazepine (Tegretol)
- Keywords
- Epilepsy, lamotrigine, cognitive function
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lamotrigine (Lamictal)Drug
Also called lamictal
lamotrigine: titration for 8 weeks (25 mg~200 mg per 2 weeks) and maintenance for 40 weeks (200 mg)
Carbamazepine (Tegretol)Drug
Also called Tegretol
Carbamazepine: titration for 8 weeks (100 mg~600 mg) and maintenance for 40 weeks (600 mg)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | lamotrigine Receives: Drug: lamotrigine (Lamictal) |
| 2 | Active comparator | carbamazepine Receives: Drug: Carbamazepine (Tegretol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients
Measured: 48 weeks
Secondary outcomes (1)
Seizure outcome and tolerability
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMay 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korean Epilepsy Society
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Sang-Ahm Lee, Professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896987
- Sponsor's protocol ID
- 106172
- Status last verified
- May 2009
- First submitted
- 11 May 2009
- Last updated
- 12 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized, Multicenter Comparative Clinical Trial of Lamotrigine or Carbamazepine for Cognitive Function as Initial Monotherapy in Adult Untreated Epilepsies
- ClinicalTrials.gov ID
- NCT00896987
- Acronym / sponsor ID
- 106172
- Conditions
- Epilepsy
- Keywords
- Epilepsy, lamotrigine, cognitive function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Korean Epilepsy SocietyUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- May 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: lamotrigine (Lamictal)lamotrigine |
| 2 | Active comparator | Drug: Carbamazepine (Tegretol)carbamazepine |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lamotrigine (Lamictal)Also: lamictallamotrigine: titration for 8 weeks (25 mg~200 mg per 2 weeks) and maintenance for 40 weeks (200 mg) | Drug | 1 |
| Carbamazepine (Tegretol)Also: TegretolCarbamazepine: titration for 8 weeks (100 mg~600 mg) and maintenance for 40 weeks (600 mg) | Drug | 2 |
Primary outcome
To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients
Time frame: 48 weeks
1 secondary outcome
Seizure outcome and tolerability
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-Ahm Lee, Professor principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lamotrigine (Lamictal) and Carbamazepine (Tegretol) in people with Epilepsy, run by Korean Epilepsy Society at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define the superiority of Lamictal in cognitive function comparing to carbamazepine in newly diagnosed adult partial epilepsy patients (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2009.