Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures
NCT ID: NCT01147003
Last Updated: 2020-12-17
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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COMPLETED
PHASE2
93 participants
INTERVENTIONAL
2010-06-30
2011-09-30
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 low dose
Investigational new drug, company code: BGG492
Placebo
Placebo
BGG492 high dose
Investigational new drug, company code: BGG492
Interventions
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Investigational new drug, company code: BGG492
Placebo
Investigational new drug, company code: BGG492
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 antiepileptic drugs (AEDs) within the last 2 years prior to screening.
* 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.
* Cohort 1 patients must be receiving stable treatment with 1 or a maximum of 2 AEDs.Cohort 2 patients must be receiving stable treatment with 1, 2, or 3 AEDs.
Exclusion Criteria
* History of psychogenic seizures.
* Absences, myoclonic seizures e.g. in the context of primary generalized epilepsy.
* Previous history of Lennox-Gastaut syndrome.
* Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization.
* Pregnant or nursing (lactating) women.
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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Barrow Neurological Clinics at St. Joseph's Hospital and MC
Phoenix, Arizona, United States
Center for Neurosciences
Tucson, Arizona, United States
Clinical Trials, Inc.
Little Rock, Arkansas, United States
Medical Center of the Rockies
Loveland, Colorado, United States
AMO Corporation
Tallahassee, Florida, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Investigative Site - Private Practice
Ocean Springs, Mississippi, United States
St.John's Research Institute, Inc
Springfield, Missouri, United States
Renown Institute for Neurosciences
Reno, Nevada, United States
NJ to Capital Health in Hamilton
Somerset, New Jersey, United States
Princeton and Rutgers Neurology
Somerset, New Jersey, United States
NYU Comprehensive Epilepsy Center
New York, New York, United States
Thomas Jefferson University, Dept. of Psychiatry & Neurology
Philadelphia, Pennsylvania, United States
Neurological Clinic of Texas
Dallas, Texas, United States
Novartis Investigative Site
Sofia, , Bulgaria
Novartis Investigative Site
Bernau, , Germany
Novartis Investigative Site
Bielefeld, , Germany
Novartis Investigative Site
Bonn, , Germany
Novartis Investigative Site
Kehl-Kork, , Germany
Novartis Investigative Site
Marburg, , Germany
Novartis Investigative SIte
Regensburg, , Germany
Novartis Investigative Site
Tübingen, , Germany
Novartis Investigative Site
Ulm, , Germany
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Kecskemét, , Hungary
Novartis Investigative Site
Szombathely, , Hungary
Novartis Investigative Site
Bologna, , Italy
Novartis Investigative Site
Catanzaro, , Italy
Novartis Investigative Site
Florence, , Italy
Novartis Investigative Site
Milan, , Italy
Novartis Investigative Site
Milan, , Italy
Novartis Investigative Site
Napoli, , Italy
Novartis Investigative Site
Venezia, , Italy
Novartis Investigative Site
Gdansk, , Poland
Novartis Investigative Site
Krakow, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Banská Bystrica, , Slovakia
Novartis Investigative Site
Bratislava, , Slovakia
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Košice, , Slovakia
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Aarau, , Switzerland
Novartis Investigative Site
Bern, , Switzerland
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Zurich, , Switzerland
Novartis Investigative Site
Changhua, , Taiwan
Novartis Investigative Site
Kaohsiung City, , Taiwan
Novartis Investigative Site
Lin-ko, , Taiwan
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Taipei, , Taiwan
Countries
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Related Links
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Results for CBGG492A2207 on the Novartis clinical trials website
Other Identifiers
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2009-017961-52
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBGG492A2207
Identifier Type: -
Identifier Source: org_study_id
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