A 12-week, multi-center, randomized, double-blind, placebo-controlled efficacy and safety study examining seizure frequency of BGG492 capsules administrated orally three times daily (TID) as adjunctive treatment in patients with partial onset seizures - ND

• Register: EUCTR
• Last refreshed on: 12 June 2012
• Main ID: EUCTR2009-017961-52-IT
• Date of registration: 08/04/2010
• Prospective Registration: No
• Primary sponsor: NOVARTIS FARMA
• Public title: A 12-week, multi-center, randomized, double-blind, placebo-controlled efficacy and safety study examining seizure frequency of BGG492 capsules administrated orally three times daily (TID) as adjunctive treatment in patients with partial onset seizures - ND
• Scientific title: A 12-week, multi-center, randomized, double-blind, placebo-controlled efficacy and safety study examining seizure frequency of BGG492 capsules administrated orally three times daily (TID) as adjunctive treatment in patients with partial onset seizures - ND
• Date of first enrolment: 19/03/2010
• Target sample size: 168
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017961-52
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany, Hungary, Italy, Slovakia

Key inclusion & exclusion criteria

Inclusion criteria:
Key inclusion criteria: ? Male and female outpatients age 18 to 65 years (inclusive) ? Weight of ≥ 50 kg (110 lb) ? Have a diagnosis of epilepsy (≥ 2 years prior to screening) with partial seizures with or without secondarily generalized seizures according to the International League Against Epilepsy?s Classification of Epileptic Seizures ? Have uncontrolled partial seizures despite having been treated with at least two different antiepileptic drugs within the last 2 years prior to screening (given concurrently or sequentially) ? Have at least 4 partial seizures (defined as simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with secondary generalization or a combination of these types for this inclusion criterion) during the 4-week baseline period and the 4 weeks immediately preceding the baseline period (retrospective and/or prospective data) ? Have no 28-day seizure-free period during the 8 weeks preceding randomization. ? Must be receiving stable treatment with 1 or a maximum of 2 AEDs
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Key exclusion criteria: ? Any of the following seizure conditions: Presence of only non-motor simple partial seizures Psychogenic seizures Absences and/or myoclonic seizures e.g. in the context of primary generalized epilepsy; Previous history of Lennox-Gastaut syndrome Status epilepticus or seizure clusters where individual seizures cannot be counted according to the judgment of the investigator occurring within 52 weeks prior to randomization


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

refractory partial-onset seizures
MedDRA version: 9.1 Level: LLT Classification code 10065336

Intervention(s)

Product Code: BGG492
Pharmaceutical Form: Capsule, hard
CAS Number: 912574-69-7
Current Sponsor code: BGG492
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: The key secondary objective is to evaluate the responder rate (responder defined as patients with a 50% or greater reduction in seizure frequency from baseline) of BGG492 (administered orally TID) compared to the placebo during the 4-week (Week 7 ? Week 10) 100 mg double-blind maintenance period.

Primary end point(s): primary efficacy assessment: seizure counts (partial seizures only) during the 28-day baseline period and the week 7-10 maintenance period in comparison to placebo.

Main Objective: The primary objective of this study is to evaluate the efficacy of BGG492 100 mg (administered orally TID) compared to placebo assessed as a change in seizure frequency from the 4-week baseline period (Weeks -4 to -1) to the 100 mg maintenance double-blind period (Week 7 ? Week 10). The evaluation of an additional arm is planned depending on the availability of additional data.

Secondary ID(s)

2009-017961-52-DE

CBGG492A2207