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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01147003
First received: June 15, 2010
Last updated: March 6, 2013
Last verified: March 2013
  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:


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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Arizona
Barrow Neurological Clinics at St. Joseph's Hospital and MC
Phoenix, Arizona, United States, 85013
Center for Neurosciences
Tucson, Arizona, United States, 85718
United States, Arkansas
Clinical Trials, Inc.
Little Rock, Arkansas, United States, 72205
United States, Colorado
Medical Center of the Rockies
Loveland, Colorado, United States, 80538
United States, Florida
AMO Corporation
Tallahassee, Florida, United States, 32308
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Mississippi
Investigative Site - Private Practice
Ocean Springs, Mississippi, United States, 39564
United States, Missouri
St.John's Research Institute, Inc
Springfield, Missouri, United States, 65804
United States, Nevada
Renown Institute for Neurosciences
Reno, Nevada, United States, 89521
United States, New Jersey
NJ to Capital Health in Hamilton
Somerset, New Jersey, United States, 08873
Princeton and Rutgers Neurology
Somerset, New Jersey, United States, 08873
United States, New York
NYU Comprehensive Epilepsy Center
New York, New York, United States, 10016
United States, Pennsylvania
Thomas Jefferson University, Dept. of Psychiatry & Neurology
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Neurological Clinic of Texas
Dallas, Texas, United States, 75230
Bulgaria
Novartis Investigative Site
Sofia, Bulgaria, 1113
Germany
Novartis Investigative Site
Bernau, Germany, 16321
Novartis Investigative Site
Bielefeld, Germany, 33617
Novartis Investigative Site
Bonn, Germany, 53127
Novartis Investigative Site
Kehl-Kork, Germany, 77694
Novartis Investigative Site
Marburg, Germany
Novartis Investigative SIte
Regensburg, Germany
Novartis Investigative Site
Tuebingen, Germany, 72076
Novartis Investigative Site
Ulm, Germany
Hungary
Novartis Investigative Site
Budapest, Hungary, 1096
Novartis Investigative Site
Kecskemet, Hungary, 6000
Novartis Investigative Site
Szombathely, Hungary, 9700
Italy
Novartis Investigative Site
Bologna, Italy, 40123
Novartis Investigative Site
Catanzaro, Italy, 88100
Novartis Investigative Site
Firenze, Italy, 50143
Novartis Investigative Site
Milano, Italy, 20142
Novartis Investigative Site
Milano, Italy, 40123
Novartis Investigative Site
Napoli, Italy, 80131
Novartis Investigative Site
Venezia, Italy, 30122
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Republic of, 738-736
Novartis Investigative Site
Seoul, Korea, Republic of, 135-710
Novartis Investigative Site
Seoul, Korea, Republic of, 120-752
Novartis Investigative Site
Seoul, Korea, Republic of, 110-744
Poland
Novartis Investigative Site
Gdansk, Poland, 80-303
Novartis Investigative Site
Krakow, Poland, 31-209
Novartis Investigative Site
Warsaw, Poland, 02-957
Slovakia
Novartis Investigative Site
Banska Bystrica, Slovakia, 975 17
Novartis Investigative Site
Bratislava, Slovakia
Novartis Investigative Site
Kosice, Slovakia, 041 90
Switzerland
Novartis Investigative Site
Aarau, Switzerland, 5001
Novartis Investigative Site
Bern, Switzerland, 3010
Novartis Investigative Site
Zuerich, Switzerland, 8008
Taiwan
Novartis Investigative Site
Changhua, Taiwan
Novartis Investigative Site
Kaohsiung, Taiwan
Novartis Investigative Site
Lin-ko, Taiwan, 33305
Novartis Investigative Site
Taipei, Taiwan, 112
Novartis Investigative Site
Taipei, Taiwan
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals 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 September 18, 2014