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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01147003

Enrollment

Registered

2010-06-22

Start date

2010-06-30

Completion date

2011-09-30

Last updated

2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial Onset Seizures

Keywords

Seizure frequency, nervous system diseases, brain diseases, neurologic manifestations, adjunctive treatment, AEDs, antiepileptic drug

Brief summary

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

Interventions

DRUGInvestigational new drug, company code: BGG492

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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/

Design outcomes

Primary

Measure	Time frame
To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period.	28 days

Secondary

Measure	Time frame
To evaluate the efficacy of BGG492 compared to placebo as a change in seizure frequency from baseline period to maintenance period.	28 days
Responder rate: analysis of patients with a 50% or greater reduction in seizure frequency of BGG492 during the maintenance period.	28 days
Safety and tolerability of BGG492 compared to placebo.	12 weeks
Pharmacokinetic profile of BGG492	10 weeks

Countries

Bulgaria, Germany, Hungary, Italy, Poland, Slovakia, South Korea, Switzerland, Taiwan, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026