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Clinical Trials/CTRI/2010/091/001213
CTRI/2010/091/001213CompletedPhase 2

A 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study Examining Seizure Frequency of BGG492 Capsules administrated orallythree times daily (TID) as Adjunctive Treatment in Patients With Partial Onset Seizures

ovartis Health care Private Limited0 sites126 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
126
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility 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)
  • •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

  • •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
  • •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

Investigators

Sponsor
ovartis Health care Private Limited

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