E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
epilepsis with seizures of focal origin |
|
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 |
To compare efficacy and tolerability of flexible dose adjusted pregabalin as first-line add-on treatment |
|
E.2.2 | Secondary objectives of the trial |
To campare efficacy and tolerability to fixed dose administration of pregabelin |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- informed consent in written form - men and women, 18-85 years of age - diagnosis of epilepsy according to criteria of the International Leage Against Epilepsy - at least 2 epileptic seizures prior to study inclusion - patients treated with one or two anticonvulsants, benzodiazepine emergency medication may be applied additionally prior to the study - patients must be able to understand and comply with the study protocol and fill out a seizure diary - women without childbearing potential. As such are considered: 2 years postmenopausal or women following: bilateral ovariectomy, bilateral ligation of tubes or hysterectomy - women with childbearing potential practicing highly effective method of birth control. as such are considered: oral contraceptives with at least 50 microgram estrogen per tablet, hormonal intrauterin device (UID), male condom plus spermicide, female condom, monogamic sexual relationship with a vasectomised partner or sexual abstinence after consulting the sponsor - patients with impaired renal function (creatinine-clearance minor 60 and more than or right 30 ml/min) with adjustment of dosage according to the official producer information
|
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E.4 | Principal exclusion criteria |
- patients unable to understand the patient´s information and give informed consent - patients having participated in another clinical trial within the last 4 weeks prior to the study or currently participating - treatment with more than 2 well tolerated anticonvulsants of the first class (according to the DGN-guidelines 2005) prior to the study - patients actually or during last 3 months prior to the study treated with pregabalin - patients with known intolerance or severe effects during previous treatment with pregabalin - patients with a history of pseudo-seizures - patients with a history of status epilepticus - pregnant or breast-feeding women - women who do not practice a reliable method of birth control - patients suffering any severe, progressive or potentially life-threatening disease - patients with clinically important impairment pancreatic or hepatic function - patients with impairment of renal function with a creatinine clearance minor 30 ml/min - patients with a history of alcoholism or drug abuse - patients with a severe psychiatric disease, especially when suicidal (exception: mild or medium degree depression without suicidal tendency) - patients with abnormal laboratory evaluations if considered clinically significant by the investigator - patients who are dependent on the sponsor or investigator |
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E.5 End points |
E.5.1 | Primary end point(s) |
fraction of patients with complete seizure control |
|
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 | Yes |
E.6.3 | Therapy | Yes |
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) | 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 | Yes |
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 | Yes |
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.8.3 |
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 | No |
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 | 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
| |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |