Focal EpilepsyPhase 4NCT02208492
The Effects on Cognitive Function of Levetiracetam (Keppra®) Compared to Carbamazepine (Tegretol®, Carmazepine®) as Monotherapy for Children With Partial Seizure; A Multicentric Randomized Controlled Study
A Phase 4 study testing Levetiracetam and Carabamazepine in people with Focal Epilepsy, run by Yonsei University at 1 site in South Korea.
Trial summary
Unlike the first generation antiepileptic medications, newer drugs for epilepsy such as levetiracetam are reported to have less adverse effect in children but not many studies have systematically reviewed the subject. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Focal Epilepsy
- What is being tested?
- Levetiracetam and Carabamazepine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Feb 2014
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients from age 4 to 16, who have been diagnosed with focal epilepsy
- Patients who have experienced minimal two unprovoked seizures, or patients who have had one unprovoked seizure and have shown focal abnormality in the EEG
- Patients who have not received any antiepileptic medications prior to the study (Those who have been treated with rescue medication are eligible)
- Patients with eligible consent or with legal guardians have given official consent
Who cannot join
- Patients with progressive CNS disease, or systemic illness
- Patients with level of SGOT/SPGT above the doubled normal level or BUN/Creatinine above the 3 times of the normal range
- Patients who had used other anti-epileptic medication during any period of the trial, including baseline period. (Benzodiazepine used as rescue therapy is acceptable)
- Patients who show hypersensitive reaction to the study medication.
- Patients with any psychological problems.
- Patients deemed inappropriate for the study by the investigators
Trial locations and contacts
1 site in 1 country.
About this study
Unlike the first generation antiepileptic medications, newer drugs for epilepsy such as levetiracetam are reported to have less adverse effect in children but not many studies have systematically reviewed the subject. This study aims to prospectively evaluate the effect of levetiracetam on neurocognition, behavioral issues and quality of life, as well as its seizure control efficacy and other adverse events in pediatric epilepsy patients, in comparison to carbamazepine, one of the classic antiepileptic medication, widely prescribed for both partial and generalized seizures, despite its well known side effects.
This multicenter, open-label, parallel-group trial is expected to enroll 130 patients from age 4 to 16 woh will be randomized into two groups, which will be prescribed with levetiracetam or carbamazepine. Series of neuropsychological assessment and behavioral and life evaluations of the patients will be performed at baseline period and after the 52 weeks of study period.
- Conditions
- Focal Epilepsy
- Being tested
- Levetiracetam, Carabamazepine
- Keywords
- Levetiracetam, Carabamazepine
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Levetiracetam is a second-generation antiepileptic drug that has been approved for the treatment of epilepsy in both children and adults. This anticonvulsant works by binding to the synaptic vesicle protein 2A resulting in a possible effect on neurotransmitter release from presynaptic vesicles, while the exact mechanism of action is still unclear. In both adults and children, levetiracetam treatment in has a proven efficacy in both localization-related and generalized epilepsies. In contrast to first generation, levetiracetam reports less side effects of somnolence or lethargy, but behavioral adverse events, such as changed mood state, aggression, and irritability are noted, but only a few studies have reported such effects in a systemic fashion.
CarabamazepineDrug
Carbamazepine, a first-generation antiepileptic medication, stabilizes the inactivated state of voltage-gated sodium channels, making fewer of these channels available to subsequently open, which leaves the affected cells less excitable and less seizure prone. It is approved for both focal seizures and generalized tonic-clonic or combined seizures for adults and children.
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Experimental | Not described Receives: Drug: Levetiracetam |
| Carabamazepine | Active comparator | Not described Receives: Drug: Carabamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment and comparative analysis of initial and follow-up Neuropsychological evaluation in both treated groups. (Levetiracetam and Carbamazepine)
changes in a series of follow-up neurocognitive, behavioral, and emotional function tests (Korean Wechsler Intelligence Scale for Children-Third edition (K-WISC-III, for subjects 6-16 years old)19, 20 or the Korean Weschler Preschool and Primary Scale of Intelligence-Third edition (K-WIPSSI-III, for ages 4-6), Korean-Child Behavior Checklist (K-CBCL), Children's Depression Inventory (CDI) 24 and Revised Children's Manifest Anxiety Scale (RCMAS))
Measured: 52 weeks
Secondary outcomes (1)
Seizure control efficacy
Comparison of baseline frequency to final follow-up frequency during the last 24 weeks of the maintenance period(at last visit at 52 week time point)
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 posted5 Aug 2014 (estimated)
- Study startSep 2011
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focal 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208492
- Sponsor's protocol ID
- 4-2011-0365
- Status last verified
- Dec 2014
- First submitted
- 3 Aug 2014
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jung DE, Yu R, Yoon JR, Eun BL, Kwon SH, Lee YJ, Eun SH, Lee JS, Kim HD, Nam SO, Kim GH, Hwang SK, Eom S, Kang DR, Kang HC. Neuropsychological effects of levetiracetam and carbamazepine in children with focal epilepsy. Neurology. 2015 Jun 9;84(23):2312-9. doi: 10.1212/WNL.0000000000001661. Epub 2015 May 6.
PubMed 25948717
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects on Cognitive Function of Levetiracetam (Keppra®) Compared to Carbamazepine (Tegretol®, Carmazepine®) as Monotherapy for Children With Partial Seizure; A Multicentric Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02208492
- Acronym / sponsor ID
- 4-2011-0365
- Conditions
- Focal Epilepsy
- Keywords
- Levetiracetam, Carabamazepine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 5 Aug 2014 (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.
Unlike the first generation antiepileptic medications, newer drugs for epilepsy such as levetiracetam are reported to have less adverse effect in children but not many studies have systematically reviewed the subject. This study aims to prospectively evaluate the effect of levetiracetam on neurocognition, behavioral issues and quality of life, as well as its seizure control efficacy and other adverse events in pediatric epilepsy patients, in comparison to carbamazepine, one of the classic antiepileptic medication, widely prescribed for both partial and generalized seizures, despite its well known side effects.
This multicenter, open-label, parallel-group trial is expected to enroll 130 patients from age 4 to 16 woh will be randomized into two groups, which will be prescribed with levetiracetam or carbamazepine. Series of neuropsychological assessment and behavioral and life evaluations of the patients will be performed at baseline period and after the 52 weeks of study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Experimental | Drug: Levetiracetam |
| Carabamazepine | Active comparator | Drug: Carabamazepine |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients from age 4 to 16, who have been diagnosed with focal epilepsy
- Patients who have experienced minimal two unprovoked seizures, or patients who have had one unprovoked seizure and have shown focal abnormality in the EEG
- Patients who have not received any antiepileptic medications prior to the study (Those who have been treated with rescue medication are eligible)
- Patients with eligible consent or with legal guardians have given official consent
Key exclusion criteria (6 listed)
- Patients with progressive CNS disease, or systemic illness
- Patients with level of SGOT/SPGT above the doubled normal level or BUN/Creatinine above the 3 times of the normal range
- Patients who had used other anti-epileptic medication during any period of the trial, including baseline period. (Benzodiazepine used as rescue therapy is acceptable)
- Patients who show hypersensitive reaction to the study medication.
- Patients with any psychological problems.
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 |
|---|---|---|
| LevetiracetamLevetiracetam is a second-generation antiepileptic drug that has been approved for the treatment of epilepsy in both children and adults. This anticonvulsant works by binding to the synaptic vesicle protein 2A resulting in a possible effect on neurotransmitter release from presynaptic vesicles, while the exact mechanism of action is still unclear. In both adults and children, levetiracetam treatment in has a proven efficacy in both localization-related and generalized epilepsies. In contrast to first generation, levetiracetam reports less side effects of somnolence or lethargy, but behavioral adverse events, such as changed mood state, aggression, and irritability are noted, but only a few studies have reported such effects in a systemic fashion. | Drug | Levetiracetam |
| CarabamazepineCarbamazepine, a first-generation antiepileptic medication, stabilizes the inactivated state of voltage-gated sodium channels, making fewer of these channels available to subsequently open, which leaves the affected cells less excitable and less seizure prone. It is approved for both focal seizures and generalized tonic-clonic or combined seizures for adults and children. | Drug | Carabamazepine |
Primary outcome
Assessment and comparative analysis of initial and follow-up Neuropsychological evaluation in both treated groups. (Levetiracetam and Carbamazepine)
Time frame: 52 weeks
changes in a series of follow-up neurocognitive, behavioral, and emotional function tests (Korean Wechsler Intelligence Scale for Children-Third edition (K-WISC-III, for subjects 6-16 years old)19, 20 or the Korean Weschler Preschool and Primary Scale of Intelligence-Third edition (K-WIPSSI-III, for ages 4-6), Korean-Child Behavior Checklist (K-CBCL), Children's Depression Inventory (CDI) 24 and Revised Children's Manifest Anxiety Scale (RCMAS))
1 secondary outcome
Seizure control efficacy
Time frame: 52 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 9 Dec 2014.
- Derived from this study: PubMed 25948717Jung DE, Yu R, Yoon JR, Eun BL, Kwon SH, Lee YJ, Eun SH, Lee JS, Kim HD, Nam SO, Kim GH, Hwang SK, Eom S, Kang DR, Kang HC. Neuropsychological effects of levetiracetam and carbamazepine in children with focal epilepsy. Neurology. 2015 Jun 9;84(23):2312-9. doi: 10.1212/WNL.0000000000001661. Epub 2015 May 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Levetiracetam and Carabamazepine in people with Focal 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 4 inclusion and 6 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 9 Dec 2014. 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?
Assessment and comparative analysis of initial and follow-up Neuropsychological evaluation in both treated groups. (Levetiracetam and Carbamazepine) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02208492, which also lists 1 linked publication.
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 9 Dec 2014.