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NCT01147003 Clinical Trial

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

Partial Onset Seizures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01147003
Other study ID # CBGG492A2207
Secondary ID 2009-017961-52
Status Completed
Phase Phase 2
First received
Last updated
Start date June 2010
Est. completion date September 2011

Study information
Verified date March 2013
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 93
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Investigational new drug, company code: BGG492

• Placebo

• Investigational new drug, company code: BGG492

Locations
Country Name City State
Bulgaria Novartis Investigative Site Sofia
Germany Novartis Investigative Site Bernau
Germany Novartis Investigative Site Bielefeld
Germany Novartis Investigative Site Bonn
Germany Novartis Investigative Site Kehl-Kork
Germany Novartis Investigative Site Marburg
Germany Novartis Investigative SIte Regensburg
Germany Novartis Investigative Site Tuebingen
Germany Novartis Investigative Site Ulm
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Kecskemet
Hungary Novartis Investigative Site Szombathely
Italy Novartis Investigative Site Bologna
Italy Novartis Investigative Site Catanzaro
Italy Novartis Investigative Site Firenze
Italy Novartis Investigative Site Milano
Italy Novartis Investigative Site Milano
Italy Novartis Investigative Site Napoli
Italy Novartis Investigative Site Venezia
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul
Poland Novartis Investigative Site Gdansk
Poland Novartis Investigative Site Krakow
Poland Novartis Investigative Site Warsaw
Slovakia Novartis Investigative Site Banska Bystrica
Slovakia Novartis Investigative Site Bratislava
Slovakia Novartis Investigative Site Kosice
Switzerland Novartis Investigative Site Aarau
Switzerland Novartis Investigative Site Bern
Switzerland Novartis Investigative Site Zuerich
Taiwan Novartis Investigative Site Changhua
Taiwan Novartis Investigative Site Kaohsiung
Taiwan Novartis Investigative Site Lin-ko
Taiwan Novartis Investigative Site Taipei
Taiwan Novartis Investigative Site Taipei
United States Johns Hopkins Hospital Baltimore Maryland
United States Neurological Clinic of Texas Dallas Texas
United States Clinical Trials, Inc. Little Rock Arkansas
United States Medical Center of the Rockies Loveland Colorado
United States NYU Comprehensive Epilepsy Center New York New York
United States Investigative Site - Private Practice Ocean Springs Mississippi
United States Thomas Jefferson University, Dept. of Psychiatry & Neurology Philadelphia Pennsylvania
United States Barrow Neurological Clinics at St. Joseph's Hospital and MC Phoenix Arizona
United States Renown Institute for Neurosciences Reno Nevada
United States NJ to Capital Health in Hamilton Somerset New Jersey
United States Princeton and Rutgers Neurology Somerset New Jersey
United States St.John's Research Institute, Inc Springfield Missouri
United States AMO Corporation Tallahassee Florida
United States Center for Neurosciences Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Bulgaria,  Germany,  Hungary,  Italy,  Korea, Republic of,  Poland,  Slovakia,  Switzerland,  Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period. 28 days
Secondary To evaluate the efficacy of BGG492 compared to placebo as a change in seizure frequency from baseline period to maintenance period. 28 days
Secondary Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period. 28 days
Secondary Safety and tolerability of BGG492 compared to placebo. 12 weeks
Secondary Pharmacokinetic profile of BGG492 10 weeks
See also
  Status Clinical Trial Phase
Completed NCT01710657 - A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures Phase 3
Completed NCT00975715 - Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures Phase 2/Phase 3
Completed NCT02072824 - A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures. Phase 3
Completed NCT01830868 - A Post-marketing Observational Study Of The Use Of Zonisamide (ZNS) in the Adjunctive Treatment Of Adult Patients With Partial Onset Seizures (Study E2090-E044-410) (ZOOM)
Completed NCT03201900 - Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Participants With Partial Onset Seizures (Including Secondarily Generalized Seizures (FREEDOM Study) Phase 3
Completed NCT01338805 - Phase II BGG492 Capsule Extension for Partial Epilepsy Phase 2
Completed NCT01407523 - An Open Label Study of L059 Intravenous (IV) in Japanese Epilepsy Subjects With Partial Onset Seizures Phase 2
Completed NCT04252846 - A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy
Completed NCT01051193 - Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures Phase 2/Phase 3
Completed NCT03836924 - A Study to Assess Safety and Efficacy of Perampanel in Indian Participants as an Adjunctive Treatment in Partial Onset Seizures With or Without Secondary Generalized Seizures in Participants With Epilepsy Aged 12 Years or Older
Completed NCT01506882 - An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy Phase 3
Completed NCT03288129 - Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures Phase 4
Withdrawn NCT01167335 - Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures Phase 2
Completed NCT01830400 - A Post-marketing Study Evaluating Eslicarbazepine Acetate (ESL) as Adjunctive Treatment in Partial-Onset Seizures (Study E2093-E044-404) (EPOS) N/A
Completed NCT00655486 - Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures Phase 3
Completed NCT00655551 - Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures Phase 3
No longer available NCT01871233 - An Extended Access Program for Perampanel

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