Clinical trial NCT02150213: Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adrenocortical Adenoma
Endometrial Stromal Sarcomas
Keywords: Adrenocortical Adenoma,
Endometrial Stromal sarcomas
BGG492
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-05-29
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805).

Detailed description: The purpose of the study was to provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805). Data from study CBGG492A2216 was used to support the clinical safety assessment of BGG492 regarding the observance of uterine endometrial stromal tumors and adrenal cortical adenomas at least one year after the completion of BGG492 treatment.

Eligibility criteria: 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;
3. Total exposure to BGG492 treatment in Study BGG492A2207 and/or BGG492A2212 had to have been greater than 28 days
4. At least 1 year had to have elapsed since the patient received his or her last dose of BGG492.

Exclusion Criteria:

- There were no exclusion criteria for this study. All patients meeting the inclusion criteria were eligible to participate in the follow-up safety assessments

Primary outcomes:
measure: Incidence of Adrenal Cortical Adenomas
timeFrame: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212
measure: Incidence of Uterine Endometrial Stromal Sarcomas
timeFrame: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Novartis Investigative Site
state: Florida
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Monroe Township
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Bernau
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Kehl-Kork
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Kecskemet
country: Hungary
facility: Novartis Investigative Site
city: Szombathely
country: Hungary
facility: Novartis Investigative Site
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Hlohovec
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: