Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Partial Onset Seizures

In brief

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

Key facts

Study ID

NCT01167335

Run by

Novartis

People needed

0

Starts

2010-08-01

Last updated by the study team

2012-05-01

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 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

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
• Pregnant or nursing (lactating) women
• Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• 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

Full record on ClinicalTrials.gov

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