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

Novartis

Status and phase: Completed; Phase 2

Conditions: Partial Onset Seizures

Treatments: Drug: Placebo; Drug: Investigational new drug, company code: BGG492

Study type: Interventional

Funder types: Industry

Identifiers

NCT01147003

CBGG492A2207

2009-017961-52 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 93 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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93 participants in 3 patient groups, including a placebo group

BGG492 low dose

Experimental group

Treatment:

Drug: Investigational new drug, company code: BGG492

Drug: Investigational new drug, company code: BGG492

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

BGG492 high dose

Experimental group

Treatment:

Drug: Investigational new drug, company code: BGG492

Drug: Investigational new drug, company code: BGG492