epilepsis with seizures of focal origin
Conditions
Interventions
Trade Name: Pregabalin / Lyrica
Product Name: Pregabalin / Lyrica
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pregabalin/ Lyrica
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Neuro-Consil GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare efficacy and tolerability of flexible dose adjusted pregabalin as first-line add-on treatment;Secondary Objective: To campare efficacy and tolerability to fixed dose administration of pregabelin;Primary end point(s): fraction of patients with complete seizure control | — |
Countries
Germany
Outcome results
None listed