EpilepsyPhase 4NCT01127165
Low and High Dose Zonisamide in Children as Monotherapy
A Phase 4 study testing zonisamide low dose group and zonisamide high dose group in people with Epilepsy, run by Eisai Korea Inc. at 11 sites in South Korea.
Trial summary
The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in children with epilepsy. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- zonisamide low dose group and zonisamide high dose group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 11 sitesSouth Korea
- Study dates
- Mar 2006to Jul 2009
- 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 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients with epilepsy whose age is 2~15 years old.
- Patients had at least two seizures for the last 6 months before entry.
- Patients who had never taken antiepileptic drugs.
- Patients with no chance of progressive disease based on the result of magnetic resonance imaging (MRI) or electroencephalogram (EEG).
- Agreement of the guardian is needed.
Who cannot join
- Patients who have progressive central nervous system (CNS) disease.
- Patients with serious disorder.
- Patients who have abnormal liver function (serum glutamic oxaloacetic transaminase [SGOT]) or (serum glutamic pyruvic transaminase [SGPT]) values more than twice the normal values.
- Patients who have abnormal renal function (blood urea nitrogen (BUN) or Creatinine) values more than three times the normal values.
- Hemolytic anemia.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Dongsan Medical Center of Keimyung Univ.
Seoul
Gangnam Severance Hospital
Seoul
Inje Univ. Ilsan-Paik Hospital
Seoul
Inje Univ. Sanggye-Paik Hospital
Seoul
Korea Univ. Ansan Hospital
Seoul
Korea Univ. Guro Hospital
Seoul
National Health Insurance Corporation Ilsan Hospital
Seoul
Severance Hospital
Seoul
Soonchunhyang Univ. Cheonan Hospital
Seoul
Soonchunhyang Univ. Hospital
Seoul
Yeungnam University Medical Center
Seoul
About this study
Official title: A Multi-center Comparative Trial of Low and High Dose Zonisamide in Children as Monotherapy
The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in children with epilepsy.
- Conditions
- Epilepsy
- Being tested
- zonisamide low dose group, zonisamide high dose group
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zonisamide low dose groupDrug
Initial dose was 2mg/kg/day, increased after 1~2 weeks to 3~4mg/kg/day.
zonisamide high dose groupDrug
Initial dose was 2mg/kg/day, increased after 2~4 weeks to 6~8mg/kg/day.
| Study group | Role | What they receive |
|---|---|---|
| Zonisamide Low Dose Group | Experimental | Not described Receives: Drug: zonisamide low dose group |
| Zonisamide High Dose group | Experimental | Not described Receives: Drug: zonisamide high dose group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Were Assessed As Seizure Free
The percentage of participants who showed no seizure during the maintenance phase.
Measured: 24 weeks
Secondary outcomes (3)
Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ)
Cognitive assessment was performed using K-WISC-III. The total score of K-WISC-III is calculated as Full Scale IQ which ranges from 31 (worst) to 151(best). Higher scores indicate greater intelligence, lower scores indicate less intelligence. Thus a positive change indicated an improvement.
Measured: Baseline and 24 weeks
Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL)
The difference of K-CBCL between before and after the administration. K-CBCL is the Korean version of CBCL which is a standardized form that parents fill out to describe their children's behavioral and emotional problems. The total score ranges 0- 234, with higher scores indicating worse behavioral and emotional problems.
Measured: Baseline and 24 weeks
Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE)
The difference of K-QOLCE between before and after the administration. K-QOLCE is Korean version of the Quality of Life in Childhood Epilepsy Questionnaire. The calculated total score ranges 0-100, with higher scores indicating higher quality of life.
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startMar 2006
- Primary completionMar 2009
- Study completionJul 2009
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Korea Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jihee Mun, Study director, Medical Department, Eisai Korea Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127165
- Sponsor's protocol ID
- E2090-S082-404
- Status last verified
- May 2010
- First submitted
- 19 May 2010
- Last updated
- 31 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Comparative Trial of Low and High Dose Zonisamide in Children as Monotherapy
- ClinicalTrials.gov ID
- NCT01127165
- Acronym / sponsor ID
- E2090-S082-404
- Conditions
- Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 20 May 2010 (estimated)
- Results
- Posted 31 Jul 2012
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 confirm the adjustment dosage of zonisamide as monotherapy in children with epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zonisamide Low Dose Group | Experimental | Drug: zonisamide low dose group |
| Zonisamide High Dose group | Experimental | Drug: zonisamide high dose group |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Pediatric patients with epilepsy whose age is 2~15 years old.
- Patients had at least two seizures for the last 6 months before entry.
- Patients who had never taken antiepileptic drugs.
- Patients with no chance of progressive disease based on the result of magnetic resonance imaging (MRI) or electroencephalogram (EEG).
- Agreement of the guardian is needed.
Key exclusion criteria (5 listed)
- Patients who have progressive central nervous system (CNS) disease.
- Patients with serious disorder.
- Patients who have abnormal liver function (serum glutamic oxaloacetic transaminase [SGOT]) or (serum glutamic pyruvic transaminase [SGPT]) values more than twice the normal values.
- Patients who have abnormal renal function (blood urea nitrogen (BUN) or Creatinine) values more than three times the normal values.
- Hemolytic anemia.
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 |
|---|---|---|
| zonisamide low dose groupInitial dose was 2mg/kg/day, increased after 1~2 weeks to 3~4mg/kg/day. | Drug | Zonisamide Low Dose Group |
| zonisamide high dose groupInitial dose was 2mg/kg/day, increased after 2~4 weeks to 6~8mg/kg/day. | Drug | Zonisamide High Dose group |
Primary outcome
Percentage of Participants Who Were Assessed As Seizure Free
Time frame: 24 weeks
The percentage of participants who showed no seizure during the maintenance phase.
3 secondary outcomes
Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ)
Time frame: Baseline and 24 weeks
Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL)
Time frame: Baseline and 24 weeks
Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE)
Time frame: Baseline and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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.
Jihee Mun study director
Medical Department, Eisai Korea Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing zonisamide low dose group and zonisamide high dose group in people with Epilepsy, run by Eisai Korea Inc. at 11 sites 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 5 inclusion and 5 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 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 31 Jul 2012). 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?
Percentage of Participants Who Were Assessed As Seizure Free (time frame: 24 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 31 Jul 2012.