| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Neurology, epilepsy, primary generalized seizures |
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| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10018079 |
|
| 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 |
| Purpose of this open follow-up study is to give subjects who benefitted from LEV the opportunity to continue LEV treatment after completion of the double-blind study N166 in myoclonic seizures (protocol RPCE99E2601). Its objective is to evaluate the safety and efficacy of LEV at individualized doses with a maximum of 4000 mg/day in reducing seizures in adults suffering from primary generalized (type II) seizures. The primary efficacy variable is the number and percentage of subjects having at least six months of seizure freedom, while the secondary variables are the number and percentage remaining seizure-free, for all seizures and by seizure type, from the beginning of the trial until the last on treatment visit and the reduction and percentage reduction in seizure days per week or seizure frequency per week from baseline (of the first study in which the subject was enrolled) for all seizures and by seizure type at each six-month evaluation visit. |
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| E.2.2 | Secondary objectives of the trial |
Number and percentage of subjects remaining seizure-free, for all seizures and by seizure type, from the beginning of the trial until the last on-treatment visit.
Reduction and percentage reduction in seizure days per week or seizure frequency per week from baseline (of the first study in which the subject was enrolled) for all seizures and by seizure type at each six-month evaluation visit.
Criteria for evaluation: Seizure count (either days with seizures for uncountable seizures or actual seizure frequency for countable seizures).
Exploratory:Quality of life assessment (QOLIE-31-P) at each one-year evaluation visit (for subjects who completed this QoL questionnaire in studies N166 and N01057).
The study site in Innsbruck is the only one in Austria. The study documents will submit only to the Ethics Committee in Innsbruck. At the study site in Innsbruck only adults will be included who had participate in the study N166. |
|
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
Written informed consent, dated and signed by the subject or, when needed, by (preferably both) parents or legal guardian (not applicable at the study site in Innsbruck).
Male or female children, adolescents and adults having completed the final visit of the double-blind study N166, the final visit of the double-blind study N01057, the second-year evaluation visit of the open follow-up study N164 or the final visit of the open follow-up study N129 (at the study site in Innsbruck only adults will be included).
The final visit of the previous study and entry into the present study will ideally occur on the same day.
Subjects who were/are suffering from primary generalized (type II) epileptic seizures, according to the Guidelines of the International League Against Epilepsy (ILAE). (6.)
Subjects for whom the Investigator believes a reasonable benefit (efficacy or tolerability) from the long-term administration of LEV may be expected.
Female subjects must be premenarcheal, two years postmenopausal or surgically sterile (bilateral oophorectomy or tubal ligation, complete hysterectomy) or using a medically accepted contraceptive method (intrauterine device, barrier method plus spermicide, oral contraceptive at a stable dose for one menstrual cycle prior to the start of the study, contraceptive implant inserted at least one month prior to the start of the study, or contraception injection administered one month prior to the start of the study). Abstinence will be considered as an acceptable method of contraception on a case-by-case basis upon discussion with UCB Pharma or its representative. The subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and undertake to inform the Investigator of any potential change in status.
Subjects must be considered as reliable and capable of adhering to the protocol, according to the judgement of the investigator. |
|
| E.4 | Principal exclusion criteria |
Pregnant, lactating or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
Known allergy to, or intolerance of, pyrrolidine derivatives or the other excipients of levetiracetam tablets (principally, but not exclusively, lactose, corn starch and cellulose).
Known clinically significant acute or chronic illness, for example: cardiac, renal or hepatic dysfunction, etc., which may impair reliable participation in the trial or necessitate the use of medication not allowed by protocol.
Clinically significant deviations from reference range values for laboratory parameters, as determined by the Investigator.
Receipt of any drug with possible central nervous system effects unless at a stable dose.
Receipt of any drug (other than hormonal treatment and the subject.s normal AED(s)) that may influence the metabolism of the concomitant AED(s), except if the dose has been stable before entry in the study for sufficient length of time.
History in prior levetiracetam study of poor compliance with visit schedule or medication intake.
Known alcohol or drug addiction or abuse within the past two years.
Participation in any clinical trial of another investigational drug or device during the study. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Efficacy variables:
Number and percentage of subjects having at least six months of seizure freedom
Safety Variables: These will be based on the following parameters:
. Laboratory tests
. Adverse events
. Electrocardiograms
. Physical and neurological examinations
. Vital signs
. Height and weight |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Information not present in EudraCT |
| E.6.2 | Prophylaxis | Information not present in EudraCT |
| E.6.3 | Therapy | Information not present in EudraCT |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Information not present in EudraCT |
| E.6.7 | Pharmacodynamic | Information not present in EudraCT |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| E.6.9 | Dose response | Information not present in EudraCT |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| E.6.13 | Others | Information not present in EudraCT |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Information not present in EudraCT |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | Information not present in EudraCT |
| E.8.1.4 | Double blind | Information not present in EudraCT |
| E.8.1.5 | Parallel group | Information not present in EudraCT |
| E.8.1.6 | Cross over | Information not present in EudraCT |
| E.8.1.7 | Other | Information not present in EudraCT |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
| E.8.2.2 | Placebo | Information not present in EudraCT |
| E.8.2.3 | Other | Information not present in EudraCT |
| E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| 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
|
Patient Visits are foreseen every six months until marketing approval for generalized seizures has been granted or until the project is stopped.
Initial estimate of the duration of the trial worldwide:
Q1 2001 until marketing approval by either FDA or EMEA
Approx 80 sites in Belgium, France, Germany, Ireland, Italy, Spain, Switzerland, NL, UK,Austria (one site), Canada, USA, Australia, New Zealand, and Mexico will participate at the study |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | |
| E.8.9.1 | In the Member State concerned days | |
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