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Efficacy of BGG492 in Individuals With Refractory Partial Seizures Undergoing Inpatient Evaluation for Epilepsy Surgery | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy of BGG492 in Individuals With Refractory Partial Seizures Undergoing Inpatient Evaluation for Epilepsy Surgery

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

NCT00887861•Novartis

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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 1981.
•2. Absence of evolving space-occupying lesions or progressive neurological diseases.
•3. Have normal vital signs (systolic and diastolic blood pressure and pulse rate)
•4. All female subjects must have negative pregnancy test results
•5. 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

•1. A history of frequent and/or severe status epilepticus (i.e. requiring intensive care unit treatment).
•2. Current treatment with phenobarbital, primidone or zonisamide (these drugs would have to be completely washed out before study start)
•3. Having discontinued chronic benzodiazepine and barbiturate therapy within 30 days prior to the study start
•4. Having electrodes implanted in the brain.
•5. 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.
•6. 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
•7. Having a significant illness other than epilepsy within two (2) weeks prior to initial dosing.
•8. Having recent (within the last three (3) years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc).

Locations (6)

Novartis Investigator Site

Berlin, Germany

Novartis Investigator Site

Bielefeld, Germany

Novartis Investigator Site

Bonn, Germany

Novartis Investigator Site

Erlangen, Germany

Novartis Investigator Site

Freiburg im Breisgau, Germany

Novartis Investigator Site

Munich, Germany

Key Dates

Start Date

March 1, 2009

Primary Completion Date

August 1, 2010

Completion Date

August 1, 2010

Last Updated

March 21, 2017

Enrollment

ACTUAL participants

Conditions

SeizuresEpilepsy

Interventions

Investigational new drug, company code: BGG492

DRUG

Placebo

DRUG

Thalamus Seizure Detection With a Deep Brain Stimulator System

NCT06700356

Epilepsy; Seizure

View study

RECRUITINGPHASE3

A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

NCT05077904

Stereotypical Prolonged Seizures

View study

RECRUITINGPHASE3

A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 21, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy of BGG492 in Individuals With Refractory Partial Seizures Undergoing Inpatient Evaluation for Epilepsy Surgery

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

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