Clinical trial NCT01147003: Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures
Official title: A 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study Examining Seizure Frequency of BGG492 Capsules as Adjunctive Treatment in Patients With Partial Onset Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Partial Onset Seizures
Keywords: Seizure frequency
nervous system diseases
brain diseases
neurologic manifestations
adjunctive treatment
AEDs
antiepileptic drug
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

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

Primary outcomes:
measure: To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period.
timeFrame: 28 days
Secondary outcomes:
measure: To evaluate the efficacy of BGG492 compared to placebo as a change in seizure frequency from baseline period to maintenance period.
timeFrame: 28 days
measure: Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.
timeFrame: 28 days
measure: Safety and tolerability of BGG492 compared to placebo.
timeFrame: 12 weeks
measure: Pharmacokinetic profile of BGG492
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Clinics at St. Joseph's Hospital and MC
state: Arizona
city: Tucson
country: United States
facility: Center for Neurosciences
state: Arizona
city: Little Rock
country: United States
facility: Clinical Trials, Inc.
state: Arkansas
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: Tallahassee
country: United States
facility: AMO Corporation
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Ocean Springs
country: United States
facility: Investigative Site - Private Practice
state: Mississippi
city: Springfield
country: United States
facility: St.John's Research Institute, Inc
state: Missouri
city: Reno
country: United States
facility: Renown Institute for Neurosciences
state: Nevada
city: Somerset
country: United States
facility: NJ to Capital Health in Hamilton
state: New Jersey
city: Somerset
country: United States
facility: Princeton and Rutgers Neurology
state: New Jersey
city: New York
country: United States
facility: NYU Comprehensive Epilepsy Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University, Dept. of Psychiatry & Neurology
state: Pennsylvania
city: Dallas
country: United States
facility: Neurological Clinic of Texas
state: Texas
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Bernau
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Kehl-Kork
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative SIte
city: Tuebingen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Kecskemet
country: Hungary
facility: Novartis Investigative Site
city: Szombathely
country: Hungary
facility: Novartis Investigative Site
city: Bologna
country: Italy
facility: Novartis Investigative Site
city: Catanzaro
country: Italy
facility: Novartis Investigative Site
city: Firenze
country: Italy
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Venezia
country: Italy
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Warsaw
country: Poland
facility: Novartis Investigative Site
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Aarau
country: Switzerland
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
city: Changhua
country: Taiwan
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Lin-ko
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: