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

NCT01147003 | Completed Phase 2

• 2 other identifiers: CBGG492A22072009-017961-52
• Study Type: interventional
• Target: 93
• Locations: 10 countries
• Sites: 51

Brief Summary

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

Conditions

Partial Onset Seizures

Keywords

Seizure frequency; nervous system diseases; brain diseases; neurologic manifestations; adjunctive treatment; AEDs; antiepileptic drug

Outcome Measures

Primary Outcomes (1)

• To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period.

  28 days

Secondary Outcomes (4)

• To evaluate the efficacy of BGG492 compared to placebo as a change in seizure frequency from baseline period to maintenance period.

  28 days

• Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.

  28 days

• Safety and tolerability of BGG492 compared to placebo.

  12 weeks

• Pharmacokinetic profile of BGG492

  10 weeks

Study Arms (3)

BGG492 low dose

EXPERIMENTAL

Drug: Investigational new drug, company code: BGG492

Placebo

PLACEBO COMPARATOR

Drug: Placebo

BGG492 high dose

EXPERIMENTAL

Drug: Investigational new drug, company code: BGG492

Interventions

Investigational new drug, company code: BGG492 DRUG

BGG492 low dose

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (51)

Barrow Neurological Clinics at St. Joseph's Hospital and MC

Phoenix, Arizona, 85013, United States

Location

Center for Neurosciences

Tucson, Arizona, 85718, United States

Location

Clinical Trials, Inc.

Little Rock, Arkansas, 72205, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

AMO Corporation

Tallahassee, Florida, 32308, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Investigative Site - Private Practice

Ocean Springs, Mississippi, 39564, United States

Location

St.John's Research Institute, Inc

Springfield, Missouri, 65804, United States

Location

Renown Institute for Neurosciences

Reno, Nevada, 89521, United States

Location

NJ to Capital Health in Hamilton

Somerset, New Jersey, 08873, United States

Location

Princeton and Rutgers Neurology

Somerset, New Jersey, 08873, United States

Location

NYU Comprehensive Epilepsy Center

New York, New York, 10016, United States

Location

Thomas Jefferson University, Dept. of Psychiatry & Neurology

Philadelphia, Pennsylvania, 19107, United States

Location

Neurological Clinic of Texas

Dallas, Texas, 75230, United States

Location

Novartis Investigative Site

Sofia, 1113, Bulgaria

Location

Novartis Investigative Site

Bernau, 16321, Germany

Location

Novartis Investigative Site

Bielefeld, 33617, Germany

Location

Novartis Investigative Site

Bonn, 53127, Germany

Location

Novartis Investigative Site

Kehl-Kork, 77694, Germany

Location

Novartis Investigative Site

Marburg, Germany

Location

Novartis Investigative SIte

Regensburg, Germany

Location

Novartis Investigative Site

Tübingen, 72076, Germany

Location

Novartis Investigative Site

Ulm, Germany

Location

Novartis Investigative Site

Budapest, 1096, Hungary

Location

Novartis Investigative Site

Kecskemét, 6000, Hungary

Location

Novartis Investigative Site

Szombathely, 9700, Hungary

Location

Novartis Investigative Site

Bologna, 40123, Italy

Location

Novartis Investigative Site

Catanzaro, 88100, Italy

Location

Novartis Investigative Site

Florence, 50143, Italy

Location

Novartis Investigative Site

Milan, 20142, Italy

Location

Novartis Investigative Site

Milan, 40123, Italy

Location

Novartis Investigative Site

Napoli, 80131, Italy

Location

Novartis Investigative Site

Venezia, 30122, Italy

Location

Novartis Investigative Site

Gdansk, 80-303, Poland

Location

Novartis Investigative Site

Krakow, 31-209, Poland

Location

Novartis Investigative Site

Warsaw, 02-957, Poland

Location

Novartis Investigative Site

Banská Bystrica, 975 17, Slovakia

Location

Novartis Investigative Site

Bratislava, Slovakia

Location

Novartis Investigative Site

Košice, 041 90, Slovakia

Location

Novartis Investigative Site

Seoul, 110-744, South Korea

Location

Novartis Investigative Site

Seoul, 120-752, South Korea

Location

Novartis Investigative Site

Seoul, 135-710, South Korea

Location

Novartis Investigative Site

Seoul, 738-736, South Korea

Location

Novartis Investigative Site

Aarau, 5001, Switzerland

Location

Novartis Investigative Site

Bern, 3010, Switzerland

Location

Novartis Investigative Site

Zurich, 8008, Switzerland

Location

Novartis Investigative Site

Changhua, Taiwan

Location

Novartis Investigative Site

Kaohsiung City, Taiwan

Location

Novartis Investigative Site

Lin-ko, 33305, Taiwan

Location

Novartis Investigative Site

Taipei, 112, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan

Location

Related Links

• Results for CBGG492A2207 on the Novartis clinical trials website

MeSH Terms

Conditions

Nervous System Diseases; Brain Diseases; Neurologic Manifestations

Interventions

Drugs, Investigational

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2010
• First Posted: June 22, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 17, 2020

Record last verified: 2013-03

Locations

KR (4); CH (3); DE (8); HU (3); US (14); PL (3); TW (5); BU (1); IT (7); SL (3)