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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01147003
First received: June 15, 2010
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Partial Onset Seizures
Drug: Investigational new drug, company code: BGG492
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic profile of BGG492 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 93
Study Start Date: June 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGG492 low dose Drug: Investigational new drug, company code: BGG492
Placebo Comparator: Placebo Drug: Placebo
Experimental: BGG492 high dose Drug: Investigational new drug, company code: BGG492

  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 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01147003

  Show 51 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01147003     History of Changes
Other Study ID Numbers: CBGG492A2207, 2009-017961-52
Study First Received: June 15, 2010
Last Updated: March 6, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Korea: Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Switzerland: Ethikkommission
Taiwan: Department of Health
United States: Food and Drug Administration

Keywords provided by Novartis:
Seizure frequency
nervous system diseases
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

ClinicalTrials.gov processed this record on April 17, 2014