EpilepsyPhase 4NCT01127256
Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
A Phase 4 study testing zonisamide and carbamazepine in people with Epilepsy, run by Eisai Korea Inc. at 12 sites in South Korea.
Trial summary
The purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- zonisamide and carbamazepine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 12 sitesSouth Korea
- Study dates
- 31 May 2006to 31 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Epilepsy patients over 15 years old.
- Occurrence of seizure should be more than one time within recent 3 months and more than two times within recent 6 months.
- Patients who have not taken antiepileptic drugs (AEDs) in recent 3 months.
- Female who can be in the month of pregnancy should agree to prevent conception.
- Patients who agree with Informed Consent Form.
Who cannot join
- Patients who have Myoclonic seizures and/or Absence seizures.
- Patients who have progressive central nervous system (CNS) disorder.
- Patients who have serious systemic disorder.
- Upward of doubled normal serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) level and/or tripled blood urea nitrogen (BUN)/Creatinine levels.
- Patients who have renal stones.
- Medical history of medicinal poisoning and/or alcoholism.
- Patients who have long-term medication history (more than 6 months) of zonisamide and/or carbamazepine.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
Seoul National Univ. Bundang Hosp.
Bundang
Dongguk Univ. Ilsan Hosp.
Ilsan
Inha Univ. Hosp.
Incheon
Chungnam National Univ. Hosp.
Jungnam
Boramae Medical Center
Seoul
Eulji General Hosp.
Seoul
Ewha Womans Univ. Mokdong Hospital
Seoul
Hallym Univ. Medical Center
Seoul
Hanyang Univ. Medical Center
Seoul
Konkuk Univ. Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National Univ. Hosp.
Seoul
About this study
The purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.
Read the detailed description
To compare efficacy and safety between the zonisamide group and the carbamazepine group. The zonisamide group will be divided into 2 subgroups: Slow-titration group and Fast-titration group to find out optimum titration of zonisamide. This study will proceed through 25~27 weeks.
- Conditions
- Epilepsy
- Being tested
- zonisamide, carbamazepine
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zonisamideDrug
Initial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day.
carbamazepineDrug
Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: zonisamide |
| 2 | Active comparator | Not described Receives: Drug: carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Participants With Seizure Free Rate
The percentage of participants who had no seizure during the trial.
Measured: 24 weeks
Secondary outcomes (2)
The Percentage of Participants With Retention Rate
The percentage of participants who completed the trial.
Measured: 24 weeks
Quality of Life in Epilepsy (QoL-QOLIE31)
Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.
Measured: 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 start31 May 2006
- Primary completion31 May 2009
- Study completion31 Jul 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT01127256
- Sponsor's protocol ID
- E2090-S082-405
- Status last verified
- May 2010
- First submitted
- 19 May 2010
- Last updated
- 4 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
- ClinicalTrials.gov ID
- NCT01127256
- Acronym / sponsor ID
- E2090-S082-405
- Conditions
- Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- 31 May 2006 (actual)
- Primary completion
- 31 May 2009 (actual)
- Study completion
- 31 Jul 2009 (actual)
- First posted
- 20 May 2010 (estimated)
- Results
- Posted 26 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 compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.
Detailed description
To compare efficacy and safety between the zonisamide group and the carbamazepine group. The zonisamide group will be divided into 2 subgroups: Slow-titration group and Fast-titration group to find out optimum titration of zonisamide. This study will proceed through 25~27 weeks.
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: zonisamide |
| 2 | Active comparator | Drug: carbamazepine |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Epilepsy patients over 15 years old.
- Occurrence of seizure should be more than one time within recent 3 months and more than two times within recent 6 months.
- Patients who have not taken antiepileptic drugs (AEDs) in recent 3 months.
- Female who can be in the month of pregnancy should agree to prevent conception.
- Patients who agree with Informed Consent Form.
Key exclusion criteria (7 listed)
- Patients who have Myoclonic seizures and/or Absence seizures.
- Patients who have progressive central nervous system (CNS) disorder.
- Patients who have serious systemic disorder.
- Upward of doubled normal serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) level and/or tripled blood urea nitrogen (BUN)/Creatinine levels.
- Patients who have renal stones.
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 |
|---|---|---|
| zonisamideInitial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day. | Drug | 1 |
| carbamazepineInitial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day. | Drug | 2 |
Primary outcome
The Percentage of Participants With Seizure Free Rate
Time frame: 24 weeks
The percentage of participants who had no seizure during the trial.
2 secondary outcomes
The Percentage of Participants With Retention Rate
Time frame: 24 weeks
Quality of Life in Epilepsy (QoL-QOLIE31)
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- 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.
Jihee Mun study director
Medical Department, Eisai Korea Inc.
12 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 and carbamazepine in people with Epilepsy, run by Eisai Korea Inc. at 12 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 7 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 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 26 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?
The Percentage of Participants With Seizure Free Rate (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 4 Jan 2022.