Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures
NCT ID: NCT01167335
Last Updated: 2012-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BGG492
BGG492
Placebo
Placebo
Interventions
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BGG492
Placebo
Eligibility Criteria
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Inclusion Criteria
* A diagnosis of epilepsy (≥ 2 years prior to screening) with partial seizures with or without secondarily generalized seizures
* Uncontrolled partial seizures despite having been treated with at least two different AEDs within the last 2 years prior to screening.
* Treated with a stable dose of 1-2 AEDs
* At least 4 partial seizures during the 4-week baseline period and at least 4 partial seizures during the 4 weeks prior to the baseline period.
* No 28-day seizure-free period during the 8 weeks preceding randomization
* Positive biomarker screening
Exclusion Criteria
* History of psychogenic seizures
* Absences, myoclonic seizures e.g. in the context of primary generalized epilepsy;
* Previous history of Lennox-Gastaut syndrome
* Pregnant or nursing (lactating) women
* Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization
18 Years
65 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of South Alabama
Mobile, Alabama, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Epilepsy Care Specialists, S.C.
Milwaukee, Wisconsin, United States
Novartis Investigative Site
Salzburg, , Austria
Novartis Investigative Site
Vienna, , Austria
Novartis Investigational Site
Vienna, , Austria
Novartis Investigative Site
Duffel, , Belgium
Novartis Investigative Site
Ottignies, , Belgium
Novartis Investigative Site
Sofia, , Bulgaria
Novartis Investigative Site
Greenfield Park, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Tallinn, , Estonia
Novartis Investigative Site
Tartu, , Estonia
Novartis Investigative Site
Bangalore, Karnataka, India
Novartis Investigative Site
Mumbai, Maharashtra, India
Novartis Investigative Site
Dehli, New Delhi, India
Novartis Investigative Site
Jaipur, , India
Novartis Investigative Site
Riga, , Latvia
Novartis Investigative Site
Riga, , Latvia
Novartis Investigative Site
Kaunas, , Lithuania
Novartis Investigative Site
Bucharest, , Romania
Novartis Investigative Site
Bucharest, , Romania
Novartis Investigative Site
Barcelona, , Spain
Countries
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Other Identifiers
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2010-018766-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBGG492A2211
Identifier Type: -
Identifier Source: org_study_id
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