Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures - Full Text View

Purpose

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

Condition	Intervention	Phase
Partial Onset Seizures	Drug: Investigational new drug, company code: BGG492 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Brain Diseases Neurologic Diseases Seizures

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the efficacy of BGG492 compared to placebo as a change in seizure frequency from baseline period to maintenance period. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Safety and tolerability of BGG492 compared to placebo. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Pharmacokinetic profile of BGG492 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment:	93
Study Start Date:	June 2010
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BGG492 low dose	Drug: Investigational new drug, company code: BGG492
Placebo Comparator: Placebo	Drug: Placebo
Experimental: BGG492 high dose	Drug: Investigational new drug, company code: BGG492

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147003

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT01147003 History of Changes
Other Study ID Numbers:	CBGG492A2207, 2009-017961-52
Study First Received:	June 15, 2010
Last Updated:	March 6, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Italy: The Italian Medicines Agency Korea: Food and Drug Administration Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Slovakia: State Institute for Drug Control Switzerland: Ethikkommission Taiwan: Department of Health United States: Food and Drug Administration

Keywords provided by Novartis:

Seizure frequency
nervous system diseases
brain diseases
neurologic manifestations

adjunctive treatment
AEDs
antiepileptic drug

Additional relevant MeSH terms:

Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013