E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Epilepsy - refractory Partial Onset Seizure |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061334 |
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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 purpose of this open-label long-term follow-up trial is to give subjects with partial onset seizures, who may have benefited from ucb 34714 as adjunctive treatment in a previous trial, the opportunity to continue ucb 34714 treatment after completion of an initial study which allowed access to the present trial.
The Primary Objective of this trial is to evaluate the long-term safety and tolerability of ucb 34714 at individualized doses with a maximum of 150 mg/day in subjects suffering from partial onset seizures.
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E.2.2 | Secondary objectives of the trial |
To evaluate the maintenance of efficacy over time of ucb 34714. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
An Independent Ethic Committee (IEC) approved written informed consent signed and dated by the subject or legally acceptable representative(s). The consent form or a specific assent form will be signed and dated by minors, according to country-specific regulations. Male/female subjects from 16 years or older. Subjects under 18 years may only be included where legally permitted and ethically accepted. Inpatients or outpatients with partial onset seizures who were treated with ucb 34714 in previous trials / programs which allow access to the present trial. Subjects for whom the Investigator believes a reasonable benefit from the long-term administration of ucb 34714 may be expected. Female subjects without childbearing potential (premenarcheal; 2 years post-menopausal; bilateral oophorectomy or ovariectomy; bilateral salpingectomy, complete hysterectomy; congenital sterility) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method for the duration of the trial participation (Intra Uterine Device; diaphragm with spermicide; male or female condom with spermicide; oral hormonal contraceptive; non- oral hormonal contraceptive medication; bilateral tubal ligation; monogamous relationship with vasectomized partner). In particular, oral or depot contraceptive treatment with at least 30 µg [or 50 µg if associated with carbamazepine (CBZ)] ethinylestradiol per intake or double-barrier contraception are acceptable methods. 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. Subject/legally acceptable representative considered as reliable and capable of adhering to the protocol (e.g.; able to understand and complete diaries and questionnaires), visit schedule or medication intake according to the judgment of the Investigator |
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E.4 | Principal exclusion criteria |
Severe medical, neurological and psychiatric disorders, or laboratory values which may have an impact on the safety of the subject. Subject having clinically significant deviations from reference range values for laboratory parameters: creatinine clearance < 50 mL/min, platelets < 100,000/l, or neutrophil cells < 1,800/l). ucb 34714 / N01125 CONFIDENTIAL Protocol RPCE03D0801 Final amended version / 01-Apr-2005 / Page 38 of 91 A Poor compliance with visit schedule or medication intake in previous ucb 34714 trial. Impaired hepatic function: ALAT/SGPT, ASAT/SGOT, alkaline phosphatase, GT value of more than three times the upper limit of the reference range. Participation in any clinical trial of another investigational drug or device during the study. If the Investigator has any medically valid reason to doubt the eligibility of a subject, the subject should not be included into the trial. If however, the Investigator has any other kind of doubts concerning the eligibility, he/she should consult the Sponsor’s CRP or representative for clarification. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Criteria for efficacy evaluation : The primary efficacy variable: is based on the seizure frequency per week for partial onset seizures (type I) by 3-month periods over the Evaluation Period (V1 until the last evaluation visit). Seizure frequency per week will be derived from the seizure count information recorded on the DRC and is defined as the number of seizures standardized to a seven day period. It is computed as the number of seizures recorded over the period, divided by the total number of days in that period, multiplied by 7. The periods considered in the definition of efficacy variables are the following: 3-month periods over the Evaluation Period (V1 until the last evaluation visit)
Safety variables: Adverse events reporting. Laboratory tests (including blood and urine). Electrocardiogram (ECG) measurements. Physical and neurological examinations. Vital signs. Body weight. Plasma concentration of concomitant AEDs and ucb 34714. The periods considered in the definition of safety variables are the following: Evaluation Period (V1 until the last evaluation visit). Down-titration Period. Post-treatment Period.
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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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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) | No |
E.8.2.2 | Placebo | No |
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.8.5 | 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 | 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 | 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
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The end of trial is defined as the date of database lock as, at that time, interactions between the Sponsor and the Investigator(s) with possible impact on subjects data have ended. |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |