EpilepsyPhase 4NCT01140867
Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy
A Phase 4 study testing zonisamide in people with Epilepsy, run by Eisai Korea Inc. at 10 sites in South Korea.
Trial summary
The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 29 Feb 2008to 31 Mar 2011
- 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 patient over 15 years old who agrees with Informed Consent Form
- Patient who has classifiable uncontrolled partial epilepsy according to International Classification of Epileptic Seizures.
- Patient who has 3 ~ dozens of partial seizure (average more than once seizure per 4 weeks) last 12 weeks despite taking 1 ~ 3 antiepileptic drug(s).
- Patient who takes 1 ~ 3 marketed antiepileptic drug(s) excluding zonisamide at point of enrollment time.
- Before study visit, patient who takes stable dose of antiepileptic drug more than 4 weeks.
Who cannot join
- Patient who has progressive central nervous system (CNS) disorder and/or degenerative disease of the brain.
- Patient who experiences pseudoseizures and/or who has uncountable clusters.
- Patient who has serious systemic or drug metabolism affecting disorder .
- Upward of doubled normal glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), bilirubin, blood urea nitrogen (BUN), creatinine levels.
- Patient who has absolute neutrophil counts <1800/mm3 or platelets <100,000/mm3.
- Patient who has medical history of renal stones.
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- Patient who is allergic to sulfonamide.
- Medical history of medicinal poisoning and/or alcoholism and/or serious psychological disorder.
- Pregnant women, lactating women, women of childbearing age who do not use a preventive method of conception.
- A terminal patient and/or a scheduled surgical patient.
- Patient who has medication history of zonisamide.
- Patient who participated other clinical trial within the last 12 weeks at point of enrollment time of this study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Dong-A University Hospital, Dept. of Neurology
Busan
Inje Univ. Pusan Paik Hospital, Dept. of Neurology
Busan
Keimyung Univ.Dongsan Medical Centre, Dept. of Neurology
Daegu
Kyungpook Natl. Univ. Hosp., Dept. of Neurology
Daegu
Yeungnam Univ. Medical Center, Dept. of Neurology
Daegu
Gachon Medical School Gil Medical Centre, Dept.of Neurology
Incheon
Natl. Health Insurance Corporation Ilsan Hosp., Dept. of Neurology
Koyang
Bundang CHA Hospital, Dept. of Neurology
Seongnam
Kangdong Sacred Heart Hosp., Dept. of Neurology
Seoul
Severance Hospital, Dept. of Neurology
Seoul
About this study
Official title: A Korean Open-label, Multi-center, Community-based Trial Assessing the Efficacy and Safety of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy
The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy.
Read the detailed description
The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy. Subject takes zonisamide for 16 weeks (4 weeks-titration period, 8 weeks maintenance period). Dose range of zonisamide is 100 ~ 400 mg/day and target dose is 300 mg/day. After 16 weeks, zonisamide efficacy is measured by seizure reduction rate (Each type of seizure: simple partial seizures [SPS], complex partial seizures [CPS], simple partial seizures evolving into generalized tonic-clonic convulsions [SGTC] and total seizure frequency), seizure free rate, responder rate, quality of life in epilepsy (QOLIE-31) and investigator's global evaluation scale. Safety of zonisamide in this study will be estimated by adverse event profile, retention rate and dose of exposure. The duration of this clinical study is 2 years including period of subject enrollment.
- Conditions
- Epilepsy
- Being tested
- zonisamide
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zonisamideDrug
zonisamide 100 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: zonisamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure Reduction Rate
The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.
Measured: Baseline and 16 weeks
Secondary outcomes (3)
Seizure Free Rate
The percentage of the participants who experienced no seizure during the trial.
Measured: 16 weeks
Responder Rate
The percentage of participants whose median percentage change in seizure frequency after Zonisamide treatment is reduced over 50%.
Measured: Baseline and 16 weeks
QoL-QOLIE31 (Quality of Life in Epilepsy)
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: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study start29 Feb 2008
- Primary completion31 Aug 2010
- Study completion31 Mar 2011
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
- Single group
- Masking
- None (open label)
- Enrolment
- 121 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
- NCT01140867
- Sponsor's protocol ID
- E2090-S082-409
- Status last verified
- May 2011
- 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
- A Korean Open-label, Multi-center, Community-based Trial Assessing the Efficacy and Safety of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy
- ClinicalTrials.gov ID
- NCT01140867
- Acronym / sponsor ID
- E2090-S082-409
- Conditions
- Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Feb 2008 (actual)
- Primary completion
- 31 Aug 2010 (actual)
- Study completion
- 31 Mar 2011 (actual)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Posted 8 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy.
Detailed description
The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy. Subject takes zonisamide for 16 weeks (4 weeks-titration period, 8 weeks maintenance period). Dose range of zonisamide is 100 ~ 400 mg/day and target dose is 300 mg/day. After 16 weeks, zonisamide efficacy is measured by seizure reduction rate (Each type of seizure: simple partial seizures [SPS], complex partial seizures [CPS], simple partial seizures evolving into generalized tonic-clonic convulsions [SGTC] and total seizure frequency), seizure free rate, responder rate, quality of life in epilepsy (QOLIE-31) and investigator's global evaluation scale. Safety of zonisamide in this study will be estimated by adverse event profile, retention rate and dose of exposure. The duration of this clinical study is 2 years including period of subject enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: zonisamide |
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 patient over 15 years old who agrees with Informed Consent Form
- Patient who has classifiable uncontrolled partial epilepsy according to International Classification of Epileptic Seizures.
- Patient who has 3 ~ dozens of partial seizure (average more than once seizure per 4 weeks) last 12 weeks despite taking 1 ~ 3 antiepileptic drug(s).
- Patient who takes 1 ~ 3 marketed antiepileptic drug(s) excluding zonisamide at point of enrollment time.
- Before study visit, patient who takes stable dose of antiepileptic drug more than 4 weeks.
Key exclusion criteria (12 listed)
- Patient who has progressive central nervous system (CNS) disorder and/or degenerative disease of the brain.
- Patient who experiences pseudoseizures and/or who has uncountable clusters.
- Patient who has serious systemic or drug metabolism affecting disorder .
- Upward of doubled normal glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), bilirubin, blood urea nitrogen (BUN), creatinine levels.
- Patient who has absolute neutrophil counts <1800/mm3 or platelets <100,000/mm3.
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 |
|---|---|---|
| zonisamidezonisamide 100 mg tablet | Drug | 1 |
Primary outcome
Seizure Reduction Rate
Time frame: Baseline and 16 weeks
The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.
3 secondary outcomes
Seizure Free Rate
Time frame: 16 weeks
Responder Rate
Time frame: Baseline and 16 weeks
QoL-QOLIE31 (Quality of Life in Epilepsy)
Time frame: Baseline and 16 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.
10 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 in people with Epilepsy, run by Eisai Korea Inc. at 10 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 12 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 10 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 8 Sep 2011). 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?
Seizure Reduction Rate (time frame: Baseline and 16 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.