Epilepsy - partial-onset seizures with or without secondary generalisation MedDRA version: 12.1 Level: LLT Classification code 10065336 Term: Partial epilepsy
Conditions
Interventions
Product Name: Retigabine
Product Code: GW582892
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RETIGABINE
CAS Number: 150812127
Current Sponsor code: GW582892
Other descriptive name: EZO
Sponsors
GlaxoSmithKline Research and Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product or other study treatment that may impact subject eligibility is provided in the GW582892 Investigators Brochure (IB). Exemptions from the inclusion criteria are not allowed because they can potentially jeopardise the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential. Subjects eligible for enrolment in the study must meet all of the following criteria: 1. The subject has successfully completed the 20-weeks (4-weeks Titration and 16-weeks of Flexible Dose Evaluation Phases) of treatment with retigabine IR as adjunctive therapy to one of the pre-specified AEDs in the parent study RGB113905. 2. The investigator and the subject, or caregiver, if applicable, should consider it beneficial for the subject to receive continued retigabine IR therapy. 3. The subject is able and willing to maintain an accurate and complete daily written Seizure Calendar or has a caregiver who is able and willing to maintain an accurate and complete daily written Seizure Calendar for the entire duration of the study. 4. 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. 5. A female subject is eligible to enter and participate in the study if she is of: a. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post menopausal). • Pre-menopausal females with a documented (medical report verification) hysterectomy with or without oophorectomy or bi-lateral oophorectomy when reproductive status has been confirmed by hormone level assessment. • Post-menopausal females defined as being amenorrhoeic for greater than one year with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms). However, if indicated, this should be confirmed by estradiol and FSH levels consistent with menopause (according to local laboratory ranges). Women who have not been confirmed as post-menopausal should be advised to use contraception as outline in Appendix 3 b. Child-bearing potential, has a negative pregnancy test at Screening, and agrees to use one of the contraceptive methods listed in Appendix 3. c. Not pregnant or lactating or planning to become pregnant during the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exemptions from exclusion criteria are not allowed because they can potentially jeopardise the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential. Subjects meeting any of the following criteria must not be enrolled in the study: 1. 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 OLE study. 2. Is suffering from acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormalities that are likely to interfere with the study objectives. 3. Has any medical condition that, in the investigator’s judgment, is considered to be clinically significant and could potentially affect subject safety or study outcome, including but not limited to: clinically significant cardiac, renal, hepatic condition, or a condition that affects the absorption, distribution, metabolism or excretion of drugs. 4. Has any abnormality on 12-lead ECG at Screening which is clinically significant in the opinion of the investigator, or has QTc (either QTcB Bazett’s correction or QTcF Fridericia’s correction) >500 msec or >530 msec for subjects with Bundle Branch Block or an increase in QTc of >60 msec from Baseline in the parent study. 5. Unwilling or inability to follow the study procedures or reporting of AEs. 6. Is planning on following a ketogenic diet or planning surgery or implantation of a Vagus Nerve Stimulator (VNS) to control seizures during the study. Note: Subjects who already have a VNS implanted which is functional may be permitted to enter the study. 7. Has 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess long-term safety and tolerability of flexibly dosed retigabine immediate release (IR) as adjunctive therapy in adults with partial-onset seizures (POS) who completed open-label flexible dose Study RGB113905.;Secondary Objective: To assess long-term efficacy of flexibly dosed retigabine IR as adjunctive therapy in adults with partial-onset seizures (POS) who completed open-label flexible dose Study RGB113905.;Primary end point(s): Safety and tolerability end points include the following: • Incidence of adverse events (AEs) and serious adverse events (SAEs). • Proportion of subjects withdrawing due to adverse events. • Change from baseline in vital signs (blood pressure and heart rate) and weight. • Change from baseline in ECG parameters. • Incidence of haematology, chemistry and urinalysis parameters of clinical concern. • Change from baseline in haematology, chemistry and urinalysis parameters. • Changes from baseline in American Urological Association Symptom Scale (AUA SS). and Post-Void Residual (PVR) bladder ultrasound. • Summary of the Columbia Suicide Severity Rating Scale (C-SSRS). • Occurrence of new seizure type (s) i.e., not experienced before (e.g. complex partial or secondarily generalised). • Worsening of seizures. • Time to withdrawal. Baseline refers to pre-treatment values from the parent study which will be used when assessing change from baseline. | — |
Countries
Belgium, Bulgaria, Germany, Italy, Netherlands, Poland, Spain
Outcome results
None listed