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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01167335
First received: June 25, 2010
Last updated: April 30, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Partial Onset Seizures
Drug: BGG492
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGG492 Drug: BGG492
Placebo Comparator: Placebo Drug: Placebo

  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 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

  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: NCT01167335

Locations
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
Austria
Novartis Investigative Site
Salzburg, Austria, A-5020
Novartis Investigative Site
Vienna, Austria, 1090
Novartis Investigational Site
Wien, Austria, 1130
Belgium
Novartis Investigative Site
Duffel, Belgium, 2570
Novartis Investigative Site
Ottignies, Belgium, 1340
Bulgaria
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
Estonia
Novartis Investigative Site
Tallinn, Estonia, 10617
Novartis Investigative Site
Tartu, Estonia, 51014
India
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
Latvia
Novartis Investigative Site
Riga, Latvia, LV-1038
Novartis Investigative Site
Riga, Latvia, 1002
Lithuania
Novartis Investigative Site
Kaunas, Lithuania, 50009
Romania
Novartis Investigative Site
Bucharest, Romania, 024092
Novartis Investigative Site
Bucharest, Romania, 011635
Spain
Novartis Investigative Site
Barcelona, Spain, 08036
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01167335     History of Changes
Other Study ID Numbers: CBGG492A2211, 2010-018766-23
Study First Received: June 25, 2010
Last Updated: April 30, 2012
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Estonia: The State Agency of Medicine
India: Drugs Controller General of India
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Romania: National Medicines Agency
Spain: Spanish Agency of Medicines

Keywords provided by Novartis:
partial onset seizure
seizure frequency
nervous system diseases
central nervous system diseases
CNS
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
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014