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BGG492

Phase 2

Adrenocortical Adenoma | Small molecule | Oncology |Novartis AG|Trials Updated: Mar 5, 2021

BGG492 development status

Highest phase Phase 2
Registered trials 7 across 2 sponsors since Nov 2008

BGG492 target and mechanism

ModalitySmall molecule

Also known as Selurampanel

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials4
Total Enrollment203

FDA Designations

No designations recorded

BGG492 clinical trials

BGG492 · 4 trials · 5 indications

Phase 2 4
NCT02150213Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492Adrenocortical Adenoma
COMPLETED59 Analytics
NCT01338805Phase II BGG492 Capsule Extension for Partial EpilepsyPartial Onset Seizures
COMPLETED56 Analytics
NCT00892203Efficacy and Safety of BGG492 in the Treatment of MigraineMigraine
COMPLETED75 Analytics
NCT00784212Effect of BGG492 on EEG in Patients With Photosensitive EpilepsyPhotosensitive Epilepsy
COMPLETED13 Analytics
PHASE2COMPLETED
Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492
Adrenocortical AdenomaUnlock trial analytics
PHASE2COMPLETED
Phase II BGG492 Capsule Extension for Partial Epilepsy
Partial Onset SeizuresUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety of BGG492 in the Treatment of Migraine
MigraineUnlock trial analytics
PHASE2COMPLETED
Effect of BGG492 on EEG in Patients With Photosensitive Epilepsy
Photosensitive EpilepsyUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Adrenal Cortical Adenomas
Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212

Incidence of adrenal cortical adenomas as assessed by non-contrast MRI of the abdomen (CT or ultrasound of the abdomen was permitted if MRI was contraindication)

Incidence of Uterine Endometrial Stromal Sarcomas
Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212

Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)

To evaluate the long-term safety and tolerability of BGG492 capsules during the maintenance period in patients suffering from partial onset seizures
38 weeks

By measuring the number and percent of patients having any AE (advent event) by primary system organ class and/or preferred term. By laboratory, vital sign, and ECG data, summary statistics of values and change from baseline

Reduction in migraine pain
2 hours
Outcome Measure: Photoparoxysmal response (PPR) and standardized photoparoxysmal response (SPR) determined by EEG on all treatment days.
Days 1, 2 and 3

Secondary Endpoints

To evaluate the efficacy over time by the change in partial seizure frequency original Baseline Period in the double-blind study CBGG492A2207 to the Open-label Extension Maintenance Phase.
38 weeks
Responder rate: To evaluate the maintenance of efficacy by the change in responder rate and numbers of patients becoming seizure free from the original Baseline Period to the Open-label Extension Maintenance Phase.
38 weeks
Seizure counts: To evaluate the maintenance of efficacy and safety as assessed in percent change of seizure frequency of BGG492 capsules from the original Baseline Period to the Open-label Extension Maintenance Phase.
38 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
BGG492EXPERIMENTALThis was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to \> 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
ActiveEXPERIMENTAL -
ComparatorACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Cohort 1EXPERIMENTAL -
Cohort IIEXPERIMENTAL -
Cohort IIIEXPERIMENTAL -

Interventions

NameTypeDescription
MRI, CT or ultrasound was permitted if MRI was contraindicatedPROCEDUREMRI/CT/ultrasound of abdomen
Dexamethasone Supression TestPROCEDURELow dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol
SonogramPROCEDURESonogram of the uterus (females only)
BiopsyPROCEDUREUterine endometrial biopsy (females only)
BGG492DRUGNo study-drug was administered in this study
SumatriptanDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: 1. Written informed consent had to be obtained before any assessment was performed; 2. Patients had to be cooperative, willing to participate in the study assessments, and be able to report AEs (adverse events) themselves or have a caregiver who can record and report the events;...

Countries:United StatesGermanyHungaryItalySlovakiaSouth KoreaPolandSpain
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Frequently asked questions about BGG492

What is BGG492 used for?

BGG492 is an investigational small molecule being studied for several conditions, including photosensitive epilepsy, migraine, partial onset seizures, and adrenocortical adenoma. It is developed by Novartis AG and has been evaluated in Phase 2 clinical trials for these indications.

What does BGG492 target?

BGG492 is an investigational small molecule developed by Novartis AG. Its molecular target has not been disclosed in available clinical trial information. The drug has been studied in Phase 2 trials for conditions such as epilepsy and migraine.

Who makes BGG492?

BGG492 is developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker NVS. The drug is an investigational small molecule that has undergone Phase 2 clinical trials for several neurological and oncological conditions.

What phase is BGG492 in?

BGG492 is in Phase 2 clinical development. It has completed multiple Phase 2 trials, including studies in photosensitive epilepsy, migraine, and partial onset seizures. The drug is not approved and remains investigational.

What clinical trials is BGG492 in?

BGG492 has been studied in several completed Phase 2 trials. These include NCT00784212 in photosensitive epilepsy, NCT00892203 in migraine, NCT01338805 in partial onset seizures, and NCT02150213, a safety follow-up study for patients with adrenocortical adenoma and other conditions.

Is BGG492 the same as other drugs?

BGG492 is an investigational small molecule developed by Novartis AG. No alternative names for BGG492 have been disclosed in clinical trial records. It is being studied for conditions such as epilepsy, migraine, and adrenocortical adenoma.