EpilepsyPhase 4NCT00154076
A Multicenter Comparative Trial of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies
A Phase 4 study testing Zonisamide and Topiramate in people with Epilepsy, run by Eisai Korea Inc. at 1 site in South Korea.
Trial summary
To assess the efficacy and safety of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Zonisamide and Topiramate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2005to 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients over 13 years old (complete the elementary school course).
- Patients had at least two seizures in the past and at least one seizure for the last 3 months before screening.
- Patients had no antiepileptic drugs for the last 4 months.
- Women of childbearing age who agree to contraception during participating this clinical trial.
Who cannot join
- Pregnancy
- Patients who have progressive neurologic disease
- Allergy to sulfonamides
- Use of acetazolamide within a year
- Hemolytic anemia
- Patients who have abnormal liver function (GOT or GPT) values more than twice the normal values.
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- Patients who have abnormal renal function (BUN or Creatinine) values more than three times the normal values.
- Patients who have history of drug or alcohol abuse.
- Glucose-6-phosphate dehydrogenase deficiency.
- Patients who were detected with renal stones on KUB (Kidney-Ureter-Bladder) test.
- Patients who have progressive internal or surgical disease.
- Patients who have progressive psychiatric disease.
- Patients who have mental retardation (IQ 70 and less).
- Patients taking Vit C.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the efficacy and safety of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies
- Conditions
- Epilepsy
- Being tested
- Zonisamide, Topiramate
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZonisamideDrug
Also called Zonegran
Initial dose is 100mg/day, increase after 2 weeks to 200mg/day. The maximum dose is 600mg/day.
TopiramateDrug
Initial dose is 25mg/day, increase every 1 week to 100mg/day. The maximum dose is 400mg/day.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Zonisamide |
| 2 | Active comparator | Not described Receives: Drug: Topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency
Measured: 2, 4, 8, 12, 16, 20, 24 weeks
Secondary outcomes (1)
Cognitive function
Measured: 0, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionAug 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eisai Korea Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jihee Mun, Study director, Eisai Korea Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154076
- Sponsor's protocol ID
- E2090-S082-403
- Status last verified
- Aug 2009
- First submitted
- 8 Sep 2005
- Last updated
- 2 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Comparative Trial of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies
- ClinicalTrials.gov ID
- NCT00154076
- Acronym / sponsor ID
- E2090-S082-403
- Conditions
- Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 Sep 2005 (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.
To assess the efficacy and safety of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies
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: Topiramate |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 13 years old (complete the elementary school course).
- Patients had at least two seizures in the past and at least one seizure for the last 3 months before screening.
- Patients had no antiepileptic drugs for the last 4 months.
- Women of childbearing age who agree to contraception during participating this clinical trial.
Key exclusion criteria (14 listed)
- Pregnancy
- Patients who have progressive neurologic disease
- Allergy to sulfonamides
- Use of acetazolamide within a year
- 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 |
|---|---|---|
| ZonisamideAlso: ZonegranInitial dose is 100mg/day, increase after 2 weeks to 200mg/day. The maximum dose is 600mg/day. | Drug | 1 |
| TopiramateInitial dose is 25mg/day, increase every 1 week to 100mg/day. The maximum dose is 400mg/day. | Drug | 2 |
Primary outcome
Seizure frequency
Time frame: 2, 4, 8, 12, 16, 20, 24 weeks
1 secondary outcome
Cognitive function
Time frame: 0, 24 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 2 Sep 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.
Jihee Mun study director
Eisai Korea Inc.
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 Zonisamide and Topiramate in people with Epilepsy, run by Eisai Korea Inc. 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 14 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 2 Sep 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?
Seizure frequency (time frame: 2, 4, 8, 12, 16, 20, 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 2 Sep 2009.