A Long-term, Safety, Tolerability, and Efficacy Study of Retigabine Immediate-release (IR) in Asian Adults With Partial Onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Retigabine IR
Intervention description: Retigabine IR tablets will be available in 5 strengths: 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg.
Intervention MeSH terms: Ezogabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Retigabine; Drug-Resistant; Epilepsy; Partial-Onset Seizures; Safety and Tolerability; Immediate Release; Long-Term; Adjunctive Therapy; Asian Subjects; Efficacy; GW582892

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).
    

Eligibility 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.