E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065336 |
E.1.2 | Term | Partial epilepsy |
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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 primary objective of this study is to assess the long-term safety of zonisamide used as an adjunctive treatment in paediatric subjects treated with one or two other anti-epileptic drugs (AEDs). In addition, efficacy endpoints to assess long term maintenance of efficacy will be investigated. |
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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 |
312. 2. Parent/caregiver is willing to sign an informed consent where the subject is under the age of consent. 3. Subject is male or female aged 618 years inclusive, who is willing to give informed (written or verbal) assent, if applicable. If mandated by local regulations, subjects of relevant age will be required to sign an appropriate informed consent. 4. Subject is in general good health as determined by medical history, physical exam and screening laboratory results. |
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E.4 | Principal exclusion criteria |
1. Subject has a body weight < 20 kg. 2. Subject has developed a history of renal calculi or renal insufficiency (creatinine level > 135 μmol/l (1.5 mg/dl). 3. Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C. 4. Subject has a history of sensitivity to sulfonamide drugs or to zonisamide and its excipients. 5. Female subject of 10 years of age or greater, or of child bearing potential (i.e. started menses) and is not taking or prepared to take a medically acceptable form of contraception (i.e. oral contraceptive pill, surgical sterilisation, an implant or injected form of contraception, or intrauterine device), or who is not prepared to abstain from sexual activity for the duration of the study and for one month after the last administration of study medication. NOTE: Should a female subject become of child bearing potential during the study, they must be re-consented in order to undergo pregnancy testing and either confirm abstinence or receive a medically appropriate form of contraception. 6. Subject has a recent history of excessive alcohol use or drug abuse. 7. Subject has a history of suicide attempt. 8. Subject has a clinically significant organic disease. 9. Subject has a history of demonstrated non-compliance with treatment or subject or parent/legal guardian can be reasonably expected not to be compliant with study procedures or to complete the study. 10. Frequent need of rescue benzodiazepines (one or more times a month). 11. Concomitant use of acetazolamide, carbonic anhydrase inhibitors such as topiramate, furosemide and drugs with anticholinergic activity. 12. Concomitant use of felbamate or use of felbamate within 2 months prior to Visit 1 of the E2090-E044-312 study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The following parameters will be explored during the study: The primary efficacy parameter is the proportion of responders. A responder is defined as a subject with a decrease from baseline in seizure frequency of ≥ 50% during the study. |
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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 | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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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Verra' effettuata una visita di follow-up quattro settimane dopo la visita finale/di terminazione anticipata. Nel corso di questa visita i soggetti saranno sottoposti ad analisi delle assunzioni concomitanti,diario delle crisi,compliance e Aes |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |