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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

June 15, 2010
March 6, 2013
June 2010
September 2011   (final data collection date for primary outcome measure)
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 ]
Seizure counts, documenting the percent change in seizure frequency of BGG492 in the maintenance period. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01147003 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Partial Onset Seizures
  • Drug: Investigational new drug, company code: BGG492
  • Drug: Placebo
  • Experimental: BGG492 low dose
    Intervention: Drug: Investigational new drug, company code: BGG492
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: BGG492 high dose
    Intervention: Drug: Investigational new drug, company code: BGG492
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
September 2011
September 2011   (final data collection date for primary outcome measure)

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

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Germany,   Hungary,   Italy,   Korea, Republic of,   Poland,   Slovakia,   Switzerland,   Taiwan
 
NCT01147003
CBGG492A2207, 2009-017961-52
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP