EpilepsyPhase 3NCT00292461
A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures
A Phase 3 study testing Zonisamide and Lamotrigine in people with Epilepsy, run by Eisai Inc. at 8 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of zonisamide for anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial or partial with secondary generalized seizures. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Zonisamide and Lamotrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 8 sitesChina
- Study dates
- Mar 2006to Sep 2009
- Phase
- Phase 3
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must sign and date the informed consent form
- Clinical diagnosis as refractory epilepsy
Who cannot join
- Progressive neurologic disease
- Serious psychiatric disease
- Hemolytic anemia
- G6PD (glucose-6-phosphate dehydrogenase) deficiency
- Acute intermittent porphyrias
- Subjects who have received study drugs (Zonisamide, Lamotrigine) in the past
Show all 17Show fewer
- Drug or alcohol addiction
- Renal impairment (serum creatinine ≧ 1.5 mg/dl), or hepatic abnormality (ALT or AST > 2x ULN)
- Stevens-Johnson syndrome
- Progressive exfoliative dermatitis
- Pregnant, lactating or of childbearing potential female
- Regularly taking oral contraceptives
- Hypersensitivity to study drugs
- Severe cardiac disease (New York Heart Association Functional Class III and IV)
- History of malignancy within 5 years
- Taking valproic acid within 7 days prior to screening
- Subjects with simple partial seizures without motor component
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Changhua Christian Hospital
Changhua, Taiwan
Chang-Gung Memorial Hospital (CGMH)
Kaohsiung, Taiwan
Chang-Gung Memorial Hospital (CGMH)
Linkou, Taiwan
China Medical University Hospital (CMUH)
Taichun, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Chang-Gung Memorial Hospital (CGMH)
Taipei, Taiwan
Taipei Tzu Chi General Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
About this study
The purpose of this study is to evaluate the efficacy and safety of zonisamide for anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial or partial with secondary generalized seizures.
- Conditions
- Epilepsy
- Being tested
- Zonisamide, Lamotrigine
- Keywords
- Epilepsy, seizures
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZonisamideDrug
Tablet once or twice daily orally for 16 weeks
LamotrigineDrug
Tablet once daily orally for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| zonisamide | Active comparator | tablet Receives: Drug: Zonisamide |
| lamotrigine | Active comparator | tablet Receives: Drug: Lamotrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline
Percentage Change of Frequency = (T-B)/B*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)* 4 B= The monthly seizure frequence with one month prior to enrollment
Measured: Baseline and 16 weeks
Secondary outcomes (3)
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period
Measured: Baseline and 16 weeks
Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period
Measured: Baseline and 16 weeks
Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.
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 posted16 Feb 2006 (estimated)
- Study startMar 2006
- Primary completionAug 2009
- Study completionSep 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.
- More trials run by Eisai Inc.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ya-Hui Cheng, Study director, Eisai Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292461
- Sponsor's protocol ID
- E2090-AS886-202
- Status last verified
- Aug 2009
- First submitted
- 14 Feb 2006
- Last updated
- 20 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures
- ClinicalTrials.gov ID
- NCT00292461
- Acronym / sponsor ID
- E2090-AS886-202
- Conditions
- Epilepsy
- Keywords
- Epilepsy, seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 16 Feb 2006 (estimated)
- Results
- Posted 15 Aug 2011
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 evaluate the efficacy and safety of zonisamide for anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial or partial with secondary generalized seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zonisamide | Active comparator | Drug: Zonisamidetablet |
| lamotrigine | Active comparator | Drug: Lamotriginetablet |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must sign and date the informed consent form
- Clinical diagnosis as refractory epilepsy
Key exclusion criteria (17 listed)
- Progressive neurologic disease
- Serious psychiatric disease
- Hemolytic anemia
- G6PD (glucose-6-phosphate dehydrogenase) deficiency
- Acute intermittent porphyrias
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 |
|---|---|---|
| ZonisamideTablet once or twice daily orally for 16 weeks | Drug | zonisamide |
| LamotrigineTablet once daily orally for 16 weeks | Drug | lamotrigine |
Primary outcome
The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline
Time frame: Baseline and 16 weeks
Percentage Change of Frequency = (T-B)/B*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)* 4 B= The monthly seizure frequence with one month prior to enrollment
3 secondary outcomes
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period
Time frame: Baseline and 16 weeks
Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period
Time frame: Baseline and 16 weeks
Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.
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 20 May 2013.
- 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.
Ya-Hui Cheng study director
Eisai Taiwan
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zonisamide and Lamotrigine in people with Epilepsy, run by Eisai Inc. at 8 sites in China.
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 2 inclusion and 17 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 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 15 Aug 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?
The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline (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 20 May 2013.