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

• Register: EUCTR
• Last refreshed on: 22 October 2012
• Main ID: EUCTR2009-017961-52-DE
• Date of registration: 19/03/2010
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: A 12-week, multi-center,randomized, double-blind, placebo-controlled efficacy and safety study examining seizure frequency of BGG492 capsules administration orally three times daily (TID) as adjunctive treatment in patients with partial onset seizures.
• Scientific title: A 12-week, multi-center,randomized, double-blind, placebo-controlled efficacy and safety study examining seizure frequency of BGG492 capsules administration orally three times daily (TID) as adjunctive treatment in patients with partial onset seizures.
• Date of first enrolment: 06/05/2010
• Target sample size: 81
• 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 or female
- weight sup or equal to 50kg
- 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 (ILAE, 1981); Appendix 5;
The diagnosis should have been established by clinical history and abnormal
electroencephalogram (EEG) that is consistent with localization-related epilepsy (For
Cohort 1 an abnormal EEG must be dated > 2 years prior screening for inclusion. For
Cohort 2, an abnormal EEG is acceptable at any time prior to screening provided that
clinical history documents localization-related epilepsy along with AED treatment for > 2
years prior to screening).
- have uncontrolled partial seizures
- have at least 4 partial seizures
- have no 28-day seizure-free period during the 8 weeks preceding randomization
- Cohort 1 patients must be receiving stable treatment (see inclusion criteria 8.1-8.4 and 9) with 1 or a maximum of 2 AEDs ; whereas, Cohort 2 patients must be receiving stable treatment with 1, 2, or 3 AEDs

please refer to protocol for the full list
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
- History of psychogenic seizures within 52 weeks prior to screening;
- Absences and/or myoclonic seizures e.g. in the context of primarily generalized epilepsy
- Previous history of Lennox-Gastaut syndrome
- Status epilepticus or seizure clusters where individual seizures cannot be counted according to the judgement of the investigator occuring within 52 weeks prior to randomization.

please refert to protocol for the full list


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

Health Condition(s) or Problem(s) studied

refractory partial-onset seizures
MedDRA version: 12.1 Level: LLT Classification code 10065336 Term: Partial epilepsy

Intervention(s)

Product Code: BGG492
Pharmaceutical Form: Capsule, hard
Current Sponsor code: BGG492
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Code: BGG492
Pharmaceutical Form: Capsule, hard
Current Sponsor code: BGG492
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

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 detect a dose-response of BGG492 (administered
orally TID) as measured by change in seizure frequency from the 4-week baseline period
(Weeks -4 to -1) to the 4-week double-blind maintenance period (Weeks 7 to 10).

Secondary Objective: The key secondary objective is to evaluate the efficacy of BGG492 (100mg, 150 mg)
administered orally TID compared to placebo assessed as change in seizure frequency from
the 4-week baseline period (Weeks -4 to -1) to the 4-week double-blind maintenance period
(Weeks 7 to 10).

Secondary ID(s)

CBGG492A2207