A Multicenter, Double-blind, Randomized, Placebo-controlled, Two-arm Parallel-group Study of BGG492 as Monotherapy in Individuals With Refractory Partial Seizures Undergoing Inpatient Evaluation for Epilepsy Surgery

Novartis1 site in 1 country37 target enrollmentMarch 2009

ConditionsSeizures Epilepsy

InterventionsPlacebo

DrugsInvestigational new drug, company code: BGG492 Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Seizures
Sponsor: Novartis
Enrollment: 37
Locations: 1
Primary Endpoint: Measure: An efficacy of investigation drug versus Placebo in reducing the seizure rate when administered orally for up to 7days as monotherapy in patients with refractory partial seizures who are undergoing an inpatient evaluation for epilepsy
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will asses the safety and efficacy of BGG492 in reducing the seizure rate in therapy-refractory partial seizures.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

August 2010

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A diagnosis of partial seizures (with or without secondary generalization) and undergoing an evaluation for epilepsy surgery, based on the classification of the International League Against Epilepsy (ILAE), as modified in
•Absence of evolving space-occupying lesions or progressive neurological diseases.
•Have normal vital signs (systolic and diastolic blood pressure and pulse rate)
•All female subjects must have negative pregnancy test results
•Subjects must weigh at least 50 kg to participate in this study and must have a body mass index (BMI) within the range of 18 to 35.

Exclusion Criteria

•A history of frequent and/or severe status epilepticus (i.e. requiring intensive care unit treatment).
•Current treatment with phenobarbital, primidone or zonisamide (these drugs would have to be completely washed out before study start)
•Having discontinued chronic benzodiazepine and barbiturate therapy within 30 days prior to the study start
•Having electrodes implanted in the brain.
•Having evidence on physical examination, or a history of any medically significant thyroid, cardiac, respiratory, hepatic, gastrointestinal, renal, hematologic, oncologic, psychiatric or progressive neurological disorder, requiring current medical intervention/therapy likely to have a significant impact on the outcome of this study.
•With any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs, e.g. GI surgery and/or pancreatic or liver disease
•Having a significant illness other than epilepsy within two (2) weeks prior to initial dosing.
•Having recent (within the last three (3) years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc).
•Other protocol-defined inclusion/exclusion criteria may apply

Arms & Interventions

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Measure: An efficacy of investigation drug versus Placebo in reducing the seizure rate when administered orally for up to 7days as monotherapy in patients with refractory partial seizures who are undergoing an inpatient evaluation for epilepsy

Time Frame: 7 days

Secondary Outcomes

Measure: To determine the plasma levels of investigational drug in patients with refractory partial seizures.(9 days)
Measure: To evaluate the safety and tolerability of investigational drug repeated dose over 9 days in patients with refractory partial seizures(9 days)
Measure:An efficacy of investing. drug vs. Pcb in reducing the seizure rate when administered orally for up to 9days (during titration monotherapy)in pts. with refractory partial seizures who are undergoing an inpatient evaluation for epilepsy surgery.(9 days)