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Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01167335
Recruitment Status : Withdrawn
First Posted : July 22, 2010
Last Update Posted : May 1, 2012
Information provided by (Responsible Party):

Brief Summary:
This study will assess the efficacy of BGG492 as adjunctive treatment in patients with refractory partial onset seizures

Condition or disease Intervention/treatment Phase
Partial Onset Seizures Drug: BGG492 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-week, Randomized, Double-blind, Placebo-controlled Exploratory Study to Assess the Antiepileptic Activity of BGG492 Given Orally as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures
Study Start Date : August 2010
Primary Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BGG492 Drug: BGG492
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period. [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period. [ Time Frame: 28 days ]
  2. Safety and tolerability of BGG492 compared to placebo evaluated by continuous adverse event monitoring and assessment of vital signs and ECGs at each visit and laboratory assessments every 2 to 4 weeks [ Time Frame: 12 weeks ]
  3. Pharmacokinetic profile of BGG492 including plasma concentrations of BGG492 at each dose level and derived variables including AUC (area under the curve), Cmax (maximum plasma concentration), Tmax (time to maximum concentration), T1/2 (half life.) [ Time Frame: 10 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 AEDs within the last 2 years prior to screening.
  • Treated with a stable dose of 1-2 AEDs
  • 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.
  • No 28-day seizure-free period during the 8 weeks preceding randomization
  • Positive biomarker screening

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
  • Pregnant or nursing (lactating) women
  • Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization

Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167335

United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36693
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Wisconsin
Epilepsy Care Specialists, S.C.
Milwaukee, Wisconsin, United States, 53215
Novartis Investigative Site
Salzburg, Austria, A-5020
Novartis Investigative Site
Vienna, Austria, 1090
Novartis Investigational Site
Wien, Austria, 1130
Novartis Investigative Site
Duffel, Belgium, 2570
Novartis Investigative Site
Ottignies, Belgium, 1340
Novartis Investigative Site
Sofia, Bulgaria, 1113
Canada, Quebec
Novartis Investigative Site
Greenfield Park, Quebec, Canada, J4V 2J2
Novartis Investigative Site
Montreal, Quebec, Canada, H2L 4M1
Novartis Investigative Site
Tallinn, Estonia, 10617
Novartis Investigative Site
Tartu, Estonia, 51014
Novartis Investigative Site
Bangalore, Karnataka, India, 560054
Novartis Investigative Site
Mumbai, Maharashtra, India, 400012
Novartis Investigative Site
Dehli, New Delhi, India, 110002
Novartis Investigative Site
Jaipur, India, 302004
Novartis Investigative Site
Riga, Latvia, 1002
Novartis Investigative Site
Riga, Latvia, LV-1038
Novartis Investigative Site
Kaunas, Lithuania, 50009
Novartis Investigative Site
Bucharest, Romania, 011635
Novartis Investigative Site
Bucharest, Romania, 024092
Novartis Investigative Site
Barcelona, Spain, 08036
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01167335     History of Changes
Other Study ID Numbers: CBGG492A2211
2010-018766-23 ( EudraCT Number )
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: April 2012

Keywords provided by Novartis:
partial onset seizure
seizure frequency
nervous system diseases
central nervous system diseases
brain diseases
neurologic manifestations
adjunctive treatment
antiepileptic drug

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms