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Investigational new drug, company code: BGG492

Phase 2

Partial Onset Seizures | Small molecule | Neurology |Novartis AG|Last Updated: Dec 17, 2020

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment93

FDA Designations

No designations recorded

Clinical trial landscape

Investigational new drug, company code: BGG492 · 2 trials · 3 indications

Phase 2 2
NCT01147003Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset SeizuresPartial Onset Seizures
COMPLETED93 Analytics
NCT00887861Efficacy of BGG492 in Individuals With Refractory Partial Seizures Undergoing Inpatient Evaluation for Epilepsy SurgerySeizures
COMPLETED37 Analytics
PHASE2COMPLETED
Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures
Partial Onset Seizures
NCT0114700393
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PHASE2COMPLETED
Efficacy of BGG492 in Individuals With Refractory Partial Seizures Undergoing Inpatient Evaluation for Epilepsy Surgery
Seizures
NCT0088786137
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Study Endpoints

Primary Endpoints

To detect a dose-response by measuring the percent change in seizure frequency of BGG492 from baseline to maintenance period.
28 days
Measure: An efficacy of investigation drug versus Placebo in reducing the seizure rate when administered orally for up to 7days as monotherapy in patients with refractory partial seizures who are undergoing an inpatient evaluation for epilepsy
7 days

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BGG492 low doseEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
BGG492 high doseEXPERIMENTAL -
BGG492EXPERIMENTAL -

Interventions

NameTypeDescription
Investigational new drug, company code: BGG492DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites51

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 ...

Countries:United StatesBulgariaGermanyHungaryItalyPolandSlovakiaSouth KoreaSwitzerlandTaiwan
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Frequently asked questions about Investigational new drug, company code: BGG492

What is BGG492 used for?

BGG492 is an investigational small molecule being developed for the treatment of seizures, including partial onset seizures. It has been studied in patients with refractory partial seizures and as an adjunctive treatment in patients with partial onset seizures. The drug is still in clinical development and is not approved.

Who makes BGG492?

BGG492 is being developed by Novartis AG, which trades under the ticker NVS. Novartis has sponsored clinical trials to evaluate the drug's efficacy and safety in patients with seizures and partial onset seizures.

What phase is BGG492 in?

BGG492 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one studying the drug in individuals with refractory partial seizures and another evaluating it as an adjunctive treatment in patients with partial onset seizures. It remains investigational.

What clinical trials is BGG492 in?

BGG492 has been studied in two completed Phase 2 trials. NCT00887861 evaluated its efficacy in individuals with refractory partial seizures undergoing inpatient evaluation for epilepsy surgery. NCT01147003 assessed its efficacy and safety as adjunctive treatment in patients with partial onset seizures.

Is BGG492 the same as any other drug?

BGG492 is an investigational drug with the company code BGG492. No alternative names have been established for this compound in the available information. It is being developed by Novartis for seizure disorders.