Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures

Completed · Phase 2 · Has a placebo group

Conditions studied: Partial Onset Seizures

In brief

This study will assess the efficacy and safety of BGG492 as adjunctive treatment in patients with partial onset seizures.

Key facts

Study ID

NCT01147003

Run by

Novartis

People needed

93

Starts

2010-06-01

Expected to finish

2011-09-01

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Outpatients ≥ 50 kg (110 lb) of weight.
• 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.

You may not qualify if…

• Presence of only non-motor simple partial seizures.
• 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.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• 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
• Barrow Neurological Clinics at St. Joseph's Hospital and MC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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