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

Phase 2

Withdrawn

• Conditions: Partial Onset Seizures
• Interventions: Drug: BGG492; Drug: Placebo

• Registration Number: NCT01167335
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-25
• Study First Submitted QC: 2010-07-20
• Study First Posted: 2010-07-22
• Study Start: 2010-08
• Primary Completion: 2010-11
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-30
• Last Update Posted: 2012-05-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BGG492	BGG492	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period.	28 days

Secondary Outcome Measures

Name	Time	Method
Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.	28 days
Safety and tolerability of BGG492 compared to placebo evaluated by continuous adverse event monitoring and assessment of vital signs and ECGs at each visit and laboratory assessments every 2 to 4 weeks	12 weeks
Pharmacokinetic profile of BGG492 including plasma concentrations of BGG492 at each dose level and derived variables including AUC (area under the curve), Cmax (maximum plasma concentration), Tmax (time to maximum concentration), T1/2 (half life.)	10 weeks

Trial Locations

Locations (5)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Epilepsy Care Specialists, S.C.; 🇺🇸 Milwaukee, Wisconsin, United States

Novartis Investigative Site; 🇪🇸 Barcelona, Spain

Novartis Investigational Site; 🇦🇹 Wien, Austria

University of South Alabama; 🇺🇸 Mobile, Alabama, United States