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Keep this study
Lead
GlaxoSmithKline
With
Bausch Health Americas, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
A male or female of 18 years of age or above capable of giving written informed consent
Have a confident diagnosis of epilepsy for \>=6 months with partial-onset seizures (POS), i.e., simple or complex POS with or without secondary generalization (classified according to the International League Against Epilepsy (ILAE) Guidelines, prior to the Screening Visit
Currently receiving monotherapy treatment with an antiepileptic drug (AED) at a stable dose for at least 28 days prior to the screening visit (Visit 1). If the subject is taking a barbiturate (e.g., phenobarbital), the dose must be stable for ≥3 months prior to the Screening Visit. Note: Subjects who have received previous adjunctive treatment but are currently taking one AED are eligible for enrolment.
Investigator-confirmed partial seizure frequency rate of ≥3 partial seizures per 28 days over the 8 weeks preceding the screening visit and must not have been seizure-free for ≥ 21 consecutive days.
Female of non-child bearing potential, or female of child-bearing potential willing to use protocol-specified methods of contraception to prevent pregnancy during the study.
Capable to comply with dosing of study drug, background AED, all study procedures and to maintain an accurate and complete daily written Seizure Calendar and Functional Status Diary
You may not be if
Have generalized epilepsy (e.g. Lennox-Gastaut, Juvenile Myoclonic epilepsy, Absence, etc.) or non-epileptic seizures.
Have had innumerable seizures within the 12-month period prior to the Screening Visit where the individual seizures cannot be counted.
Have had status epilepticus within 12 months prior to screening
Have a history of pseudo seizures, non-epileptic events or any other type of psychogenic seizures that could be confused with seizures.
Have been treated with felbamate or vigabatrin within the 6 months prior to Screening. If a subject has been previously treated with vigabatrin \>6 months prior to Screening, a visual perimetry test performed within 6 months prior to Screening must show normal visual fields or no worsening of recognized visual field abnormalities as compared with prior to vigabatrin treatment
Benzodiazepines used in any manner other than acute usage as defined in this protocol will be considered concurrent AED usage and will not be permitted
* Are using Central Nervous System (CNS)-active medication (other than concomitant AED therapy), unless the subject has been stabilized on such medication for at least 1 month prior to the Screening Visit.
Are using herbal treatments with CNS activity within at least 1 month prior to the Screening Visit
Have received ezogabine/retigabine in a previous study or have taken POTIGA or TROBALT.
Are currently following or planning to follow the ketogenic diet
Have an active Vagus Nerve Stimulator (VNS) to control seizures
Are planning surgery to control seizures during the study
Have impaired renal function as judged by a creatinine clearance of \<50 mL/min
Have a history of urinary retention or risk factors for urinary retention that in the investigator's judgment could potentially affect subject safety.
Have an average corrected QT interval (QTc), using Bazett's QT correction (QTcB), ≥450msec or ≥480msec for subjects with bundle branch block at the time of the Screening Visit
Liver function tests: alanine aminotransferase (ALT) is ≥2 times the upper limit of normal (ULN); alkaline phosphatase and bilirubin are \>1.5 × ULN (isolated bilirubin \>1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin is \<35%).
Are suffering from acute or progressive neurological disease, severe psychiatric disease, or severe mental abnormalities that are likely to interfere with the objectives of the study
Have a history of malignancy within the past 2 years; with the exception of basal cell carcinoma
Have unstable liver disease \[chronic stable hepatitis B and C are acceptable if subject otherwise meets entry criteria; chronic stable Hepatitis B to be excluded if significant immunosuppressive agents administered due to risk of hepatitis B reactivation\]
Have 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
Have an active suicidal plan/intent or have had active suicidal thoughts in the past 6 months. Have history of suicide attempt in the last 2 years or more than 1 lifetime suicide attempt.
Have a history of substance abuse (alcohol or drugs) or substance dependence within 12 months prior to screening
Have a known hypersensitivity to any components of the study medication
Have taken an investigational drug, or used an investigational device, within the previous 30 days prior to screening or plans to take an investigational drug anytime during the study.
Clareo Health | Dose-Optimization, Adjunctive Treatment Study of Ezogabine/Retigabine Immediate Release in Partial-onset Seizures
