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 shall
have a negative urine pregnancy test at visit 0, which will be confirmed
by the serum ß-HCG pregnancy test at the last visit (Visit 11) 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 361
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. Patient meets any of the withdrawal criteria in the previous VRX-RETE22-
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.
4. Female patient who has a positive pregnancy test at any time during
the study

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<br>seizure rate from the baseline phase to open-label treatment.<br>Treatment emergent adverse events;Timepoint(s) of evaluation of this end point: Percentage change in monthly seizure rate from baseline to end of open-label treatment phase

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Adverse events, vital signs, weight, clinical laboratory evaluations, 12-<br>lead ECG, post-void residual bladder ultrasound;Timepoint(s) of evaluation of this end point: Every four months

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