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

December 11, 2020 updated by: Novartis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1113
        • Novartis Investigative Site
  • Germany
      • 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
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1096
        • Novartis Investigative Site
      • Kecskemet, Hungary, 6000
        • Novartis Investigative Site
      • Szombathely, Hungary, 9700
        • Novartis Investigative Site
  • Italy
      • 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
        • Novartis Investigative Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 135-710
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 738-736
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 110-744
        • Novartis Investigative Site
  • Poland
      • Gdansk, Poland, 80-303
        • Novartis Investigative Site
      • Krakow, Poland, 31-209
        • Novartis Investigative Site
      • Warsaw, Poland, 02-957
        • Novartis Investigative Site
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Novartis Investigative Site
      • Bratislava, Slovakia
        • Novartis Investigative Site
      • Kosice, Slovakia, 041 90
        • Novartis Investigative Site
  • Switzerland
      • Aarau, Switzerland, 5001
        • Novartis Investigative Site
      • Bern, Switzerland, 3010
        • Novartis Investigative Site
      • Zuerich, Switzerland, 8008
        • Novartis Investigative Site
  • Taiwan
      • Changhua, Taiwan
        • Novartis Investigative Site
      • Kaohsiung, Taiwan
        • Novartis Investigative Site
      • Lin-ko, Taiwan, 33305
        • Novartis Investigative Site
      • Taipei, Taiwan
        • Novartis Investigative Site
      • Taipei, Taiwan, 112
        • Novartis Investigative Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Clinics at St. Joseph's Hospital and MC
      • Tucson, Arizona, United States, 85718
        • Center for Neurosciences
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Clinical Trials, Inc.
    • Colorado
      • Loveland, Colorado, United States, 80538
        • Medical Center of the Rockies
    • Florida
      • Tallahassee, Florida, United States, 32308
        • AMO Corporation
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Mississippi
      • Ocean Springs, Mississippi, United States, 39564
        • Investigative Site - Private Practice
    • Missouri
      • Springfield, Missouri, United States, 65804
        • St.John's Research Institute, Inc
    • Nevada
      • Reno, Nevada, United States, 89521
        • Renown Institute for Neurosciences
    • New Jersey
      • Somerset, New Jersey, United States, 08873
        • NJ to Capital Health in Hamilton
      • Somerset, New Jersey, United States, 08873
        • Princeton and Rutgers Neurology
    • New York
      • New York, New York, United States, 10016
        • NYU Comprehensive Epilepsy Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University, Dept. of Psychiatry & Neurology
    • Texas
      • Dallas, Texas, United States, 75230
        • Neurological Clinic of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: BGG492 low dose
Drug: Investigational new drug, company code: BGG492
Experimental: BGG492 high dose
Drug: Investigational new drug, company code: BGG492

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
28 days
Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.
Time Frame: 28 days
28 days
Safety and tolerability of BGG492 compared to placebo.
Time Frame: 12 weeks
12 weeks
Pharmacokinetic profile of BGG492
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

June 15, 2010

First Submitted That Met QC Criteria

June 16, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBGG492A2207
  • 2009-017961-52 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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