Status:
COMPLETED
Efficacy of BGG492 in Individuals With Refractory Partial Seizures Undergoing Inpatient Evaluation for Epilepsy Surgery
Lead Sponsor:
Novartis
Conditions:
Seizures
Epilepsy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will asses the safety and efficacy of BGG492 in reducing the seizure rate in therapy-refractory partial seizures.
Eligibility Criteria
Inclusion
- 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.
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00887861
Start Date
March 1 2009
End Date
August 1 2010
Last Update
March 21 2017
Active Locations (6)
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1
Novartis Investigator Site
Berlin, Germany
2
Novartis Investigator Site
Bielefeld, Germany
3
Novartis Investigator Site
Bonn, Germany
4
Novartis Investigator Site
Erlangen, Germany