Open Label-Extension Study of the Phase # VRX-RET-E22-302 Double-Blind Trial

Phase 1

• Conditions: Adult epilepsy patients with partial-onset seizures; MedDRA version: 18.1Level: LLTClassification code 10065336Term: Partial epilepsySystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2006-000956-42-BE
• Lead Sponsor: GlaxoSmithKline LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-21
• Last Update Posted: 4 January 2022

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-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.
4.Female patient who has a positive pregnancy test

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified