EpilepsyPhase 4NCT00807989
The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy
A Phase 4 study testing Carbamazepine and Lamotrigine/Valproate in people with Epilepsy, run by Yonsei University at 1 site in South Korea.
Trial summary
To evaluate the efficacy of usual monotherapy and low dose combination of Lamotrigine and Valproate. Low dose combination may be more effective and tolerable because they are low dose and VPA reduce Lamotrigine metabolism. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Carbamazepine and Lamotrigine/Valproate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2008to May 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥16yr old
- Who are diagnosed as epilepsy definitely
- Who have minimum 2 unprovoked seizures and minimum 1 seizure in previous 3 months
- Who need AED therapy and no AED medication for previous 1 year (exclude emergency medication for less than 2weeks)
- Who is not pregnant
- Who can report seizure diary by him/herself or caregiver
- Who agree to this trial and provide informed consent.
- Type of seizures : of generalized tonic-clonic, complex partial, and/or simple partial motor seizures;
Who cannot join
- Who has progressive CNS disease.
- Has serious systemic or psychiatric disease
- Who is not suitable by investigator(uncooperative)
- Who can not fill up diary check card
- Is pregnant, breastfeeding, or planning to become pregnant
- Exclusion - absence s. juvenile myoclonic epilepsy, atonic seizure, alcohol or other substance abusers, mental retardation etc.
Show all 10Show fewer
- Who cancels to agree to this trial and provide informed consent.
- ALT, AST, bilirubin and BUN/Cr levels are more than twice normal range of them
- WBC value is 2000 and less, Hb value is 9.0 and less, platelet count is 100,000 and less in CBC
- Who took investigation products before participating this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies (Phase Ⅳ)
To evaluate the efficacy of usual monotherapy and low dose combination of Lamotrigine and Valproate. Low dose combination may be more effective and tolerable because they are low dose and VPA reduce Lamotrigine metabolism.
Read the detailed description
An Open label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies
- Conditions
- Epilepsy
- Being tested
- Carbamazepine, Lamotrigine/Valproate
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbamazepineDrug
Lamotrigine/ValproateDrug
| Study group | Role | What they receive |
|---|---|---|
| Carbamazepine | Active comparator | Carbamazepine Receives: Drug: Carbamazepine |
| Lamotrigine/Valproate | Experimental | Lamotrigine and Valproate combination therapy Receives: Drug: Lamotrigine/Valproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate After 52 Weeks Maintenance Period
- Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned.
Measured: 52 weeks
Secondary outcomes (2)
Seizure Free Rate for 24 Weeks at Initial Target Dose
Measured: 24 weeks
Seizure Free Rate for 52 Weeks at Initial Target Dose
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Byung-In Lee, Principal investigator, Yonsei Univ.Kyoung Heo, Principal investigator, Yonsei Univ.Sang-Kun Lee, Principal investigator, Seoul National Univ.Sang-Ahm Lee, Principal investigator, Ulsan Univ.Dong-Jin Shin, Principal investigator, Gacheon Univ.Hong-Ki Song, Principal investigator, Hallym Univ.Young-In Kim, Principal investigator, Catholic Univ.Se-Jin Lee, Principal investigator, Youngnam Univ.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807989
- Sponsor's protocol ID
- 109887
- Status last verified
- Jun 2015
- First submitted
- 28 Nov 2008
- Last updated
- 27 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies (Phase Ⅳ)
- ClinicalTrials.gov ID
- NCT00807989
- Acronym / sponsor ID
- 109887
- Conditions
- Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 15 Dec 2008 (estimated)
- Results
- Posted 29 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of usual monotherapy and low dose combination of Lamotrigine and Valproate. Low dose combination may be more effective and tolerable because they are low dose and VPA reduce Lamotrigine metabolism.
Detailed description
An Open label, Randomized, Multicenter Clinical Trial to Compare the Efficacy and Safety of Lamotrigine / Valproate Coadministration and Carbamazepine as Initial Pharmacotherapy in Epilepsies
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbamazepine | Active comparator | Drug: CarbamazepineCarbamazepine |
| Lamotrigine/Valproate | Experimental | Drug: Lamotrigine/ValproateLamotrigine and Valproate combination therapy |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥16yr old
- Who are diagnosed as epilepsy definitely
- Who have minimum 2 unprovoked seizures and minimum 1 seizure in previous 3 months
- Who need AED therapy and no AED medication for previous 1 year (exclude emergency medication for less than 2weeks)
- Who is not pregnant
Key exclusion criteria (10 listed)
- Who has progressive CNS disease.
- Has serious systemic or psychiatric disease
- Who is not suitable by investigator(uncooperative)
- Who can not fill up diary check card
- Is pregnant, breastfeeding, or planning to become pregnant
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 |
|---|---|---|
| Carbamazepine | Drug | Carbamazepine |
| Lamotrigine/Valproate | Drug | Lamotrigine/Valproate |
Primary outcome
Retention Rate After 52 Weeks Maintenance Period
Time frame: 52 weeks
* Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned.
2 secondary outcomes
Seizure Free Rate for 24 Weeks at Initial Target Dose
Time frame: 24 weeks
Seizure Free Rate for 52 Weeks at Initial Target Dose
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Byung-In Lee principal investigator
Yonsei Univ.
Kyoung Heo principal investigator
Yonsei Univ.
Sang-Kun Lee principal investigator
Seoul National Univ.
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 Carbamazepine and Lamotrigine/Valproate in people with Epilepsy, run by Yonsei University 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 8 inclusion and 10 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 27 Jul 2015. 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?
Yes. Results are posted in the registry (first posted 29 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Retention Rate After 52 Weeks Maintenance Period (time frame: 52 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 27 Jul 2015.