- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00327717
Evaluating the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures
August 14, 2014 updated by: Eisai Inc.
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
240
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100034
- Peking University First Hospital
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Beijing, Beijing, China, 100730
- Peking Union Medical College Hospital
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Beijing, Beijing, China, 100053
- Peking Union Hospital
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Chongqing
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Chongqing, Chongqing, China, 400016
- The First Affiliated Hospital of Chongqing Medical University
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Shanghai
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Shanghai, Shanghai, China, 200003
- Shanghai Changzheng Hospital
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Shanghai, Shanghai, China, 200040
- Shanghai Hua-shan Hospital
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Shanxi
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XiÆan, Shanxi, China, 710032
- XiÆan Xijing Hospital
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Sichuan
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Chengdu, Sichuan, China, 610041
- Chengdu Huaxi Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
According to the International League Against Epilepsy (ILAE) classification of seizure type (1981) and international classification of epilepsies and epileptic syndromes (ILAE, 1989), definite diagnosis of partial seizures (with or without secondary generalized seizures) refractory to current anti epilepsy drug (AED) therapy.
Inclusion criteria:
- 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;
- 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.
Exclusion criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
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Experimental: Zonisamide 100 mg tablet
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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The median percent change in seizure frequency of all partial seizures (CP+SP+SGS) from baseline during the fixed-dose phase.
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Baseline and 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Mean Percent Change From Baseline in Complex Partial (CP) Seizure Frequency
Time Frame: Baseline and 16 weeks
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The Mean Percent Change in seizure frequency of CP from baseline during the fixed-dose phase.
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Baseline and 16 weeks
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The Mean Percent Change From Baseline in Simple Partial (SP) Seizure Frequency
Time Frame: Baseline and 16 weeks
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The Mean percent change in seizure frequency of SP from baseline during the fixed-dose phase.
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Baseline and 16 weeks
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The Mean Percent Change From Baseline in Partial Seizures With Secondary Generalization (SGS)
Time Frame: Baseline and 16 weeks
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The mean percent change in seizure frequency of SGS from baseline during the fixed-dose phase.
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Baseline and 16 weeks
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Responder Rate
Time Frame: Baseline and 16 weeks
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Responder rate is defined as percentage of participants with >=50% reduction in seizure frequency from baseline.
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Baseline and 16 weeks
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Mean Number of Seizure Free Days
Time Frame: 12 weeks
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Mean number of seizure free days per 28 day period during fixed dose phase
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12 weeks
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Mean Percentage of Change in Seizure Free Days
Time Frame: 16 weeks
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16 weeks
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Mean Time to First Seizure (Days)
Time Frame: 16 weeks
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Mean time to first seizure during fixed dose phase
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16 weeks
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Percentage of Seizure-free Participants During Fixed-dose Phase
Time Frame: 16 weeks
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Percentage of seizure-free participants during fixed-dose phase
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16 weeks
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Drop - Out Rate
Time Frame: 16 weeks
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Number of Participants who dropped out of the study.
In the Study drop-out rate is defined as number of participants.
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16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Di Hong, Eisai China Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
May 17, 2006
First Submitted That Met QC Criteria
May 17, 2006
First Posted (Estimate)
May 18, 2006
Study Record Updates
Last Update Posted (Estimate)
August 15, 2014
Last Update Submitted That Met QC Criteria
August 14, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2090-AS086-311
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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