Evaluate the Efficacy of BGG492 as Adjunctive Treatment in Patients With Refractory Partial Onset Seizures

Novartis

Status and phase: Withdrawn; Phase 2

Conditions: Partial Onset Seizures

Treatments: Drug: BGG492; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01167335

CBGG492A2211

2010-018766-23 (EudraCT Number)

Details and patient eligibility

About

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

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 AEDs within the last 2 years prior to screening.
• Treated with a stable dose of 1-2 AEDs
• 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.
• No 28-day seizure-free period during the 8 weeks preceding randomization
• Positive biomarker screening

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
• Pregnant or nursing (lactating) women
• Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization

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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0 participants in 2 patient groups, including a placebo group

BGG492

Experimental group

Treatment:

Drug: BGG492

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo