A multicenter, open-label, long-term, safety, tolerability and efficacy study of retigabine in adult epilepsy patients with partial-onset seizures (Extension of Study VRX-RET-E22-302)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 376

Inclusion Criteria

1.Patient has successfully completed the Maintenance and Transition phases of Study VRX-RET-E22-302 for the treatment of partial-onset seizures
2.Patient is expected to benefit from participation in the study in the opinion of the Investigator.
3.Women of childbearing potential and fertile males have to agree to use a medically acceptable method of birth control and females had to have a negative serum ß-HCG pregnancy test at the last visit of the Transition phase of Study VRX-RET-E22-302. A woman of childbearing potential is defined as a female who is biologically capable of becoming pregnant. A medically acceptable method of birth control includes an intrauterine device in place for at least 3 months, surgical sterilization (e.g. tubal ligation), or adequate barrier methods (e.g., diaphragm and foam). An oral contraceptive alone is not considered adequate for the purpose of this study.
4.In the opinion of the Investigator, patient is able to understand verbal and written instructions and will adhere to all study schedules and requirements.
5.Patient or legal guardian (if applicable) is informed, given ample time and opportunity to read and/or understand about his/her participation in the study, and has signed and dated the written informed consent form.

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

1.Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-302 study or is experiencing an ongoing serious adverse event.
2.Patient is receiving any investigational drug or using any experimental device in addition to Retigabine for treatment of epilepsy or any other medical condition.
3.Patient has any other condition that would prevent compliance with the study procedures or proper reporting of AEs.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the double-blind Study VRX-RET-E22-302.;Secondary Objective: To evaluate efficacy of long-term treatment with retigabine and patient quality of life, evaluated through the QOLIE-31-P questionnaire.;Primary end point(s): Porcentage change in the monthly total seizure and monthly total partial seizure rate from the baseline phase to open-label treatment.<br>Treatment emergent adverse events

Secondary Outcome Measures

Name	Time	Method

Related Trials