A Long-term, Safety, Tolerability, and Efficacy Study of Retigabine Immediate-release (IR) in Asian Adults With Partial Onset Seizures

• Status: Completed
• Trial end date: 2017-09-13
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicentre, long-term, open-label extension (OLE) study to assess the long-term safety, tolerability and efficacy of retigabine immediate-release (IR) as adjunctive therapy in adult Asian subjects with drug-resistant partial-onset seizures (POS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Ezogabine

Criteria

Inclusion Criteria:

• The subject has successfully completed the Maintenance Phase and Transition Phase of Study RTG114855.

• The subject is expected, in the opinion of the investigator, to benefit from participation in this OLE study.

• The subject or the caregiver is able and willing to maintain an accurate and complete written daily seizure calendar for the entire duration of the study.

• The subject has given written informed consent, or has a legally authorized representative who has given written informed consent, prior to the performance of any study assessments.

• A female subject is eligible to enrol and participate in the study if she is of:

nonchildbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is premenarchal or postmenopausal), premenopausal females with a documented (medical report verification) hysterectomy with or without oophorectomy, or bilateral oophorectomy when reproductive status has been confirmed by hormone level assessment, and postmenopausal females defined as being amenorrhoeic for >1 year with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms). However, if indicated, this should be confirmed by oestradiol and follicle stimulating hormone levels consistent with menopause (according to local laboratory ranges). Women who have not been confirmed as postmenopausal should be advised to use contraception.

• Childbearing potential, has a negative urine or serum pregnancy test at Screening.

• Is not pregnant or lactating or planning to become pregnant during the study.

Exclusion Criteria:

• Has met any of the withdrawal criteria in the parent study (RTG114855) or has, in the opinion of the investigator, clinically significant abnormal laboratory or ECG findings that preclude entry into RTG114873.

• Is planning to begin treatment with an investigational drug (other than retigabine) and/or an experimental device for the treatment of epilepsy or any other medical condition.

• Has any medical condition that, in the investigator's judgement, is considered to be clinically significant and could potentially affect subject safety or study outcome, including but not limited to clinically significant cardiac, renal, or hepatic condition; or a condition that affects the absorption, distribution, metabolism, or excretion of drugs.

• Is unwilling or unable to follow the study procedures or reporting of AEs.

• Has active suicidal plan/intent or has had active suicidal thoughts in the past 6 months or has history of suicide attempt in the last 2 years or >1 lifetime suicide attempt.