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

Phase 2

Completed

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

• Registration Number: NCT01147003
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-15
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-22
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Disposition First Submitted: 2013-02-18
• Disposition First Submitted QC: 2013-02-18
• Disposition First Posted: 2013-02-22
• Status Verified: 2013-03
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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 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.

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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.
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period.	28 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profile of BGG492	10 weeks
To evaluate the efficacy of BGG492 compared to placebo as a change in seizure frequency from baseline period to maintenance period.	28 days
Safety and tolerability of BGG492 compared to placebo.	12 weeks
Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.	28 days

Trial Locations

Locations (16)

AMO Corporation; 🇺🇸 Tallahassee, Florida, United States

Thomas Jefferson University, Dept. of Psychiatry & Neurology; 🇺🇸 Philadelphia, Pennsylvania, United States

Medical Center of the Rockies; 🇺🇸 Loveland, Colorado, United States

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

St.John's Research Institute, Inc; 🇺🇸 Springfield, Missouri, United States

NYU Comprehensive Epilepsy Center; 🇺🇸 New York, New York, United States

Neurological Clinic of Texas; 🇺🇸 Dallas, Texas, United States

Novartis Investigative SIte; 🇩🇪 Regensburg, Germany

Center for Neurosciences; 🇺🇸 Tucson, Arizona, United States

Princeton and Rutgers Neurology; 🇺🇸 Somerset, New Jersey, United States

Clinical Trials, Inc.; 🇺🇸 Little Rock, Arkansas, United States

Novartis Investigative Site; 🇨🇳 Taipei, Taiwan

Renown Institute for Neurosciences; 🇺🇸 Reno, Nevada, United States

Investigative Site - Private Practice; 🇺🇸 Ocean Springs, Mississippi, United States

Barrow Neurological Clinics at St. Joseph's Hospital and MC; 🇺🇸 Phoenix, Arizona, United States

NJ to Capital Health in Hamilton; 🇺🇸 Somerset, New Jersey, United States