Efficacy and tolerability of flexible dose adjusted pregabalin as first-line add-on treatment of patients with focal seizures - Pregabalin as first-line add-o
- Conditions
- epilepsis with seizures of focal origin
- Registration Number
- EUCTR2006-004201-26-DE
- Lead Sponsor
- euro-Consil GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method