Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492

Adrenocortical Adenoma, Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150213
• Other study ID #: CBGG492A2216
• Secondary ID: 2013-003431-29
• Status: Completed
• Phase: Phase 2
• First received: May 15, 2014
• Last updated: April 11, 2016
• Start date: August 2014
• Est. completion date: September 2015

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices (BfArM)South Korea: Korea Food and Drug Administration (KFDA)Slovakia: State Institute for Drug ControlItaly: Ministry of HealthHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Adrenocortical Adenoma
• Adrenocortical Adenoma,
• Endometrial Stromal Sarcomas

Intervention

Procedure:
• MRI, CT or ultrasound was permitted if MRI was contraindicated
MRI/CT/ultrasound of abdomen
• Dexamethasone Supression Test
Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol
• Sonogram
Sonogram of the uterus (females only)
• Biopsy
Uterine endometrial biopsy (females only)

Drug:
• BGG492
No study-drug was administered in this study

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Bernau
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Kehl-Kork
Germany	Novartis Investigative Site	Ulm
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Kecskemet
Hungary	Novartis Investigative Site	Szombathely
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Milano	MI
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Slovakia	Novartis Investigative Site	Banska Bystrica
Slovakia	Novartis Investigative Site	Hlohovec	Slovak Republic
Slovakia	Novartis Investigative Site	Kosice	Slovak Republic
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Monroe Township	New Jersey
United States	Novartis Investigative Site	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  Hungary,  Italy,  Korea, Republic of,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adrenal cortical adenomas	Incidence of adrenal cortical adenomas as assessed by non-contrast MRI of the abdomen (males and females)	At least one year after the patient's last dose of BGG492 in study A2207 or A2212	Yes
Primary	Incidence of uterine endometrial stromal sarcomas	Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)	t least one year after the patient's last dose of BGG492 in study A2207 or A2212.	Yes