A Multicentre, Open-Label, Long-Term, Safety and Tolerability Study of Retigabine Immediate Release (IR) in Adults with Partial-Onset Seizures (Extension of Study RGB113905: RTG113413).

Phase 3

Completed

• Conditions: epilepsy; 10029305

• Registration Number: NL-OMON34147
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

* Age 18 years and above (men or women).
* Subject has successfully completed the 20-weeks parent study RGB113905.
* Subject and investigator consider it beneficial for the subject to receive continued retigabine therapy.
* Adequate contraception for females of childbearing potential.

Exclusion Criteria

* Has met any of the withdrawal criteria in the previous RGB113905 study or has clinically significant abnormal clinical laboratory or ECG findings not resolved prior to entry to the follow-up study.
* Is planning to follow the ketogenic diet.
* Active suicidal plan/intent or has had active suicidal thoughts in the past 6 months. Has history of suicide attempt in the last 2 years or more than 1 lifetime suicide attempt.
* Pregnancy or lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Adverse events.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Efficacy.</p><br>