E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Epilepsy participant over 15 years old who agrees with Informed Consent Form
2. Participant who has classifiable uncontrolled partial epilepsy according to International Classification of Epileptic Seizures.
3. Participant 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).
4. Participant who takes 1 ~ 3 marketed antiepileptic drug(s) excluding zonisamide at point of enrollment time.
5. Before study visit, participant who takes stable dose of antiepileptic drug more than 4 weeks.
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E.4 | Principal exclusion criteria |
1. Participant who has progressive central nervous system (CNS) disorder and/or degenerative disease of the brain.
2. Participant who experiences pseudoseizures and/or who has uncountable clusters.
3. Participant who has serious systemic or drug metabolism affecting disorder .
4. Upward of doubled normal alanine transaminase (ALT), aspartate transaminase (AST), bilirubin, blood urea nitrogen (BUN), creatinine levels.
5. Participant who has absolute neutrophil counts <1800/mm3 or platelets <100,000/mm3.
6. Participant who has medical history of renal stones.
7. Participant who is allergic to sulfonamide.
8. Medical history of medicinal poisoning and/or alcoholism and/or serious psychological disorder.
9. Pregnant women, lactating women, women of childbearing age who do not use a preventive method of conception.
10. A terminal participant and/or a scheduled surgical participant.
11. Participant who has medication history of zonisamide.
12. Participant who participated other clinical trial within the last 12 weeks at point of enrollment time of this study.
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Seizure Free Rate
2. Responder Rate
3. Quality of Life in Epilepsy (QoL-QOLIE31) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 16 weeks
2. Baseline and 16 weeks
3. Baseline and 16 weeks |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |