Partial SeizuresPhase 3NCT00327717
Evaluating the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures
A Phase 3 study testing Zonisamide in people with Partial Seizures, run by Eisai Inc. at 8 sites in China.
Trial summary
The objectives of this trial are to evaluate the safety and efficacy of Zonisamide as adjunctive therapy in medically refractory patients receiving other antiepileptic drugs (AEDs). Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Partial Seizures
- What is being tested?
- Zonisamide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 8 sitesChina
- Study dates
- Sep 2006to May 2008
- 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
- Adult male or female, 16 to 70 years old;
- Classified according to the ILAE classification of seizure type (1981) and international classification of epilepsy and epileptic syndromes (ILAE, 1989) into partial seizures (with or without secondary generalized seizures);
- Based on the retrospective subject diary, at least 4 partial seizures per month ( 4 weeks ) within 12 weeks prior to entry;
- No more than 8 secondary generalized tonic, clonic, or tonic-clonic seizures per month within 12 weeks prior to entry;
- Antiepileptic therapy including at least 1-2 concomitant AEDs and were on a stable dose(s) of the same AEDs for the 3 months prior to enrollment;
- Had performed electro encephalogram (EEG) within 6 months prior to entry, and computer tomography (CT) or magnetic resonance imaging (MRI) examination to mainly exclude space-occupying disease;
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- Was able to count seizure frequencies;
- Women with child bearing potential, were not to be pregnant or nursing, and must have agreed to practice during the study a reliable form of contraception (oral contraceptive, condom, intrauterine device or diaphragm).
- Signed written informed consent and agreed to comply with the protocol.
Who cannot join
- History or evidence of a progressive central nervous system (CNS) disease;
- Nonepileptic seizures and pseudoepileptic seizures;
- Severe mental retardation or unstable psychical status;
- Clinically significant cardiac, hepatic, renal, or hematological disease, uncontrolled hypertension (systolic blood pressure (SBP) ≥150 and/or diastolic blood pressure (DBP) ≥100mmHg), Symptomatic ischemic heart disease, cerebral infarction or atherosclerosis obliterans;
- History of malignant neoplastic disease;
- Any condition that might interfere the pharmacokinetics (absorption, distribution, and/or excretion) of drugs, such as liver or kidney dysfunction, hypoproteinemia;
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- Glucose-6-phosphate dehydrogenase (G-6-PD) deficiency or history of hemolytic anemia or acute intermittent porphyria.
- History of kidney stone;
- History of alcohol or drug abuse within 2 years;
- Sensitivity to sulfonamide medications or history of severe drug allergy;
- Administration of monoamine oxidase inhibitor (MAOI), antidepressants or antipsychotic a psycho-tropic within 14 days prior to entry;
- History of status epileptics in the past years or seizure clusters where individual seizures cannot be counted ;
- History of zonisamide administration;
- History of acetazolamide administration to treat epilepsy within 2 months prior to entry;
- Joined the clinical trial of other AEDs within 30 days prior to entry;
- Pregnant women or women in lactation;
- Abnormal clinical laboratory values with clinical significance judged by investigators (for example, if abnormal hepatic function is caused by concurrent other AEDs, the abnormal value within 2 times of normal could be acceptable);
- Inability of subject to return for scheduled visits or to comply with any other aspect of the protocol.
- Subjects who, in the opinion of the investigator, were poor medical candidates or pose any other risk for therapy with an investigational drug.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Peking Union Hospital
Beijing, Beijing Municipality, 100053
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Chengdu Huaxi Hospital
Chengdu, Sichuan, 610041
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Shanghai Hua-shan Hospital
Shanghai, Shanghai Municipality, 200040
XiÆan Xijing Hospital
XiÆan, Shanxi, 710032
About this study
Official title: A Multicenter, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures
The objectives of this trial are to evaluate the safety and efficacy of Zonisamide as adjunctive therapy in medically refractory patients receiving other antiepileptic drugs (AEDs).
- Conditions
- Partial Seizures
- Being tested
- Zonisamide, Placebo
- Keywords
- Epilepsy, Partial seizures
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZonisamideDrug
Also called Zonegran
Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
PlaceboDrug
Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
| Study group | Role | What they receive |
|---|---|---|
| Zonisamide 100 mg tablet | Experimental | Not described Receives: Drug: Zonisamide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Percent Change From Baseline in All Partial Seizure Frequency (Complex Partial Seizures (CP)+ Simple Partial Seizures (SP) + Secondary Generalization Seizures (SGS)) During the Fixed-dose Phase
The median percent change in seizure frequency of all partial seizures (CP+SP+SGS) from baseline during the fixed-dose phase.
Measured: Baseline and 16 weeks
Secondary outcomes (9)
The Mean Percent Change From Baseline in Complex Partial (CP) Seizure Frequency
The Mean Percent Change in seizure frequency of CP from baseline during the fixed-dose phase.
Measured: Baseline and 16 weeks
The Mean Percent Change From Baseline in Simple Partial (SP) Seizure Frequency
The Mean percent change in seizure frequency of SP from baseline during the fixed-dose phase.
Measured: Baseline and 16 weeks
The Mean Percent Change From Baseline in Partial Seizures With Secondary Generalization (SGS)
The mean percent change in seizure frequency of SGS from baseline during the fixed-dose phase.
Measured: Baseline and 16 weeks
Responder Rate
Responder rate is defined as percentage of participants with >=50% reduction in seizure frequency from baseline.
Measured: Baseline and 16 weeks
Mean Number of Seizure Free Days
Mean number of seizure free days per 28 day period during fixed dose phase
Measured: 12 weeks
Mean Percentage of Change in Seizure Free Days
Measured: 16 weeks
Mean Time to First Seizure (Days)
Mean time to first seizure during fixed dose phase
Measured: 16 weeks
Percentage of Seizure-free Participants During Fixed-dose Phase
Percentage of seizure-free participants during fixed-dose phase
Measured: 16 weeks
Drop - Out Rate
Number of Participants who dropped out of the study. In the Study drop-out rate is defined as number of participants.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startSep 2006
- Primary completionMay 2008
- Study completionMay 2008
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 Partial SeizuresStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Di Hong, Study director, Eisai China Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327717
- Sponsor's protocol ID
- E2090-AS086-311
- Status last verified
- Aug 2014
- First submitted
- 17 May 2006
- Last updated
- 15 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures
- ClinicalTrials.gov ID
- NCT00327717
- Acronym / sponsor ID
- E2090-AS086-311
- Conditions
- Partial Seizures
- Keywords
- Epilepsy, Partial seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 18 May 2006 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this trial are to evaluate the safety and efficacy of Zonisamide as adjunctive therapy in medically refractory patients receiving other antiepileptic drugs (AEDs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zonisamide 100 mg tablet | Experimental | Drug: Zonisamide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Adult male or female, 16 to 70 years old;
- Classified according to the ILAE classification of seizure type (1981) and international classification of epilepsy and epileptic syndromes (ILAE, 1989) into partial seizures (with or without secondary generalized seizures);
- Based on the retrospective subject diary, at least 4 partial seizures per month ( 4 weeks ) within 12 weeks prior to entry;
- No more than 8 secondary generalized tonic, clonic, or tonic-clonic seizures per month within 12 weeks prior to entry;
- Antiepileptic therapy including at least 1-2 concomitant AEDs and were on a stable dose(s) of the same AEDs for the 3 months prior to enrollment;
Key exclusion criteria (19 listed)
- History or evidence of a progressive central nervous system (CNS) disease;
- Nonepileptic seizures and pseudoepileptic seizures;
- Severe mental retardation or unstable psychical status;
- Clinically significant cardiac, hepatic, renal, or hematological disease, uncontrolled hypertension (systolic blood pressure (SBP) ≥150 and/or diastolic blood pressure (DBP) ≥100mmHg), Symptomatic ischemic heart disease, cerebral infarction or atherosclerosis obliterans;
- History of malignant neoplastic disease;
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: ZonegranPatients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient. | Drug | Zonisamide 100 mg tablet |
| PlaceboPatients in placebo group were titrated with placebo in the same way as in zonisamide group. | Drug | Placebo |
Primary outcome
Median Percent Change From Baseline in All Partial Seizure Frequency (Complex Partial Seizures (CP)+ Simple Partial Seizures (SP) + Secondary Generalization Seizures (SGS)) During the Fixed-dose Phase
Time frame: Baseline and 16 weeks
The median percent change in seizure frequency of all partial seizures (CP+SP+SGS) from baseline during the fixed-dose phase.
9 secondary outcomes
The Mean Percent Change From Baseline in Complex Partial (CP) Seizure Frequency
Time frame: Baseline and 16 weeks
The Mean Percent Change From Baseline in Simple Partial (SP) Seizure Frequency
Time frame: Baseline and 16 weeks
The Mean Percent Change From Baseline in Partial Seizures With Secondary Generalization (SGS)
Time frame: Baseline and 16 weeks
Responder Rate
Time frame: Baseline and 16 weeks
Mean Number of Seizure Free Days
Time frame: 12 weeks
Mean Percentage of Change in Seizure Free Days
Time frame: 16 weeks
Mean Time to First Seizure (Days)
Time frame: 16 weeks
Percentage of Seizure-free Participants During Fixed-dose Phase
Time frame: 16 weeks
Drop - Out Rate
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- 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.
Di Hong study director
Eisai China Inc.
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 in people with Partial Seizures, 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 9 inclusion and 19 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 15 Aug 2014. 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. Some participants in this study may receive a placebo. 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 2014). 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?
Median Percent Change From Baseline in All Partial Seizure Frequency (Complex Partial Seizures (CP)+ Simple Partial Seizures (SP) + Secondary Generalization Seizures (SGS)) During the Fixed-dose Phase (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 15 Aug 2014.