A medical follow-up study in patients who received BGG492 for more than 28 days.

A multicenter medical safety follow-up study for patients with partial onset seizures who received more than 28 days of total exposure to BGG492 in studies CBGG492A2207 and/or CBGG492A2212.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003431-29-IT

Enrollment

Registered

2014-04-28

Start date

2014-05-27

Completion date

Unknown

Last updated

2016-04-11

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

Conditions

Testing for adrenal cortical adenomas in male and female patients Testing for uterine endometrial stromal sarcromas in all female patients

Interventions

Pharmaceutical Form: CAS Number: 912574-69-7 Other descriptive name: BGG492

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Written informed consent must be obtained before any assessment is performed; 2.Patients must be cooperative, willing to participate in the study assessments, and able to report adverse events themselves or have a caregiver who can record and report the events; 3.Total exposure to BGG492 treatment in study CBGG492A2207 and/or CBGG492A2212 must have been greater than 28 days; 4.At least one year must have elapsed since the patient received his or her last dose of BGG492. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17

Exclusion criteria

Exclusion criteria: There are no exclusion criteria for this study so that all patients meeting the inclusion criteria will be eligible to participate in the medical follow-up assessments.

Design outcomes

Primary

Measure	Time frame
Main Objective: To observe if patients exposed to BGG492 for more than 28 days have developed uterine endometrial stromal sarcomas (females) and/or adrenal cortical adenomas (males and females) at least one year after treatment with BGG492 has been completed;Secondary Objective: Not applicable;Primary end point(s): a) Clinically significant findings of adrenal cortical adenomas from MRI of abdomen (For males and females ) and of uterine endometrial stromal sarcomas from Sonogram/biopsy (for females only) b) Incidence and severity of AEs;Timepoint(s) of evaluation of this end point: a) Visit 2 for MRI and Visit 4 for Sonogram b) Visits 2,3,4,5 and 6.	—

Measure

Time frame

Main Objective: To observe if patients exposed to BGG492 for more than 28 days have developed uterine endometrial stromal sarcomas (females) and/or adrenal cortical adenomas (males and females) at least one year after treatment with BGG492 has been completed;Secondary Objective: Not applicable;Primary end point(s): a) Clinically significant findings of adrenal cortical adenomas from MRI of abdomen (For males and females ) and of uterine endometrial stromal sarcomas from Sonogram/biopsy (for females only) b) Incidence and severity of AEs;Timepoint(s) of evaluation of this end point: a) Visit 2 for MRI and Visit 4 for Sonogram b) Visits 2,3,4,5 and 6.

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: a) Visit 2 for MRI and Visit 4 for Sonogram b) Visits 2,3,4,5 and 6.;Secondary end point(s): a) Clinically significant findings of adrenal cortical adenomas from MRI of abdomen (For males and females ) and of uterine endometrial stromal sarcomas from Sonogram/biopsy (for females only) b) Incidence and severity of AEs	—

Countries

Germany, Hungary, Italy, Korea, Democratic People's Republic of, Poland, Slovakia, United States

Contacts

Public ContactDrug Regulatory Affairs

Novartis Farma S.p.A.

info.studiclinici@novartis.com+390296542287

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026