None listed
Conditions
Interventions
Intervention1: BGG492: 50 microgram immediate release capsule
Intervention2: BGG492: 5 microgram immediate release capsule
Control Intervention1: Placebo: Capsule
Sponsors
Novartis Health care Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female outpatients age 18 to 65 years (inclusive) 2. Are of greater than or equal to 50 kg (110 lb) of weight 3. Have a diagnosis of epilepsy (greater than or equal to 2 years prior to screening) with partial seizures with or without secondarily generalized seizures according to the International League Against Epilepsys Classification of Epileptic Seizures (ILAE, 1981) Appendix 5 The Diagnosis should have been established by clinical history and electroencephalogram (EEG) that is consistent with localization related epilepsy. Must have had either a computed tomography (CT) or magnetic resonance imaging (MRI) within the 5 years prior to screening that ruled out progressive neurological changes (e.g. Alzheimerâ??s disease, Parkinsonâ??s disease, Multiple Sclerosis); in addition, no physical examination changes suggestive of such lesions or diseases should have occurred since the imaging procedure; If a patient has not had a CT or MRI within the past 5 years, then a MRI must be performed during the screening period and the results must be reviewed for compliance with above criterion prior to randomization; 5. Must have uncontrolled partial seizures despite having been treated with at least two different anti-epileptic drugs within the last 2 years prior to screening (given concurrently or sequentially); 6. Must have at least 4 partial seizures (defined as simple partial seizures with motor signs, 7. complex partial seizures, complex partial seizures with secondary generalization or a combination of these types) during the 4-week prospective baseline period and the 4 weeks immediately preceding the baseline period (retrospective and/or prospective data) 7. Have no 28 day seizure free period during the 8 weeks preceding randomization 8. Must be receiving stable treatment (see inclusion criteria 8.1 8.4 and 9) with 1 or a maximum of 2 AEDs from the list presented below: 8.1 No change in medication type, dose or frequency for 8 weeks prior to randomization: Carbamazepine, Eslicarbazepine, Oxcarbazepine, Phenytoin, Valproate, Lacosamide, Lamotrigine, Levetiracetam, Clobazam, Topiramate, Zonisamide, Gabapentin and Pregabalin 8.2 No change in medication type, dose or frequency for 12 weeks prior to randomization: Phenobarbital and Primidone 8.3 Vagal nerve stimulation (VNS) will be counted as 1 AED 8.4 Stable benzodiazepine treatment (no change in medication type, dose, or frequency for 12 weeks prior to randomization) administered for e.g. epilepsy, anxiety, or sleep disorders will be counted as one AED Note: The use of intermittent benzodiazepines is defined in exclusion criteria 2.5 refer to Section 4.2. 9. If using a vagal nerve stimulator, the device must have been implanted for at least 22 weeks prior to randomization. Stimulator parameters may not have been changed within 8 weeks prior to randomization 10. Patients having had pre-surgical evaluations may be included. Also, patients having had brain surgery for partial seizures may be included, if surgery was performed greater than or equal to 1 year before randomization 11. Are on stable doses (constant for 4 weeks prior to randomization) of non-AED concomitant medica
Exclusion criteria
Exclusion criteria: Any of the following seizure conditions: 1.1 Presence of only non-motor simple partial seizures 1.2 History of psychogenic seizures 1.3 Absences, myoclonic seizures e.g. in the context of primary generalized epilepsy 1.4 Previous history of Lennox-Gastaut syndrome 1.5 History of status epilepticus or seizure clusters (where individual seizures cannot be counted according to the judgment of the investigator) occurring within 52 weeks prior to randomization 1.6 Only seizures caused by an underlying medical illness during the 52 weeks prior to randomization 2. Have been treated with 2.1 Felbamate, unless treatment has been continuous for greater than or equal to 2 years 2.2 Vigabatrin during the 26 weeks prior to randomization 2.3 Monoamine oxidase (MAO) inhibitors, tricyclic-antidepressants and narcotic analgesics such as e.g. morphine, oxycodone, fentanyl, codeine within 8 weeks prior to randomization 2.4 Barbiturates (except for seizure control) within 8 weeks prior to randomization 2.5 Intermittent benzodiazepines two or more times in a 4-week period prior to randomization (1-2 doses over a 24-hr period will be considered one-time use) 2.6 L-dopa formulations 2.7 Use of concomitant medication that are potential inhibitors of OATP transporters e.g. cyclosporine, rifampin, fluvastatine, fexofenadine 8 weeks prior to randomization Known history of hypersensitivity to the study drug or to drugs of similar chemical classes (e.g. sulfonamides) 4. Have had multiple drug allergies or one or more severe drug reactions to an AED, including dermatological reactions, (e.g. Stevens-Johnson syndrome, hematological, or organ toxicity reactions) a rash would not be exclusionary 5. Use of other investigational drugs within 12 weeks prior to randomization 6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a negative hCG laboratory test (greater than or equal to 5mIU per mL) at screening and a negative urine test immediately prior to administering the first dose of study medication 7. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant including women whose partners have been sterilized by vasectomy or other means, UNLESS they are • Women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner • Using two birth control methods. The two methods can be a double barrier method or a barrier method in combination with a hormonal method Adequate barrier methods of contraception include diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and or a progestational agent. Reliable contraception should be started at screening, maintained throughout the study and for 2 week after study drug discontinuation. Women are considered post menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period.Timepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactDr. Kamala Rai
Outcome results
None listed