NCT02150213

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

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adrenocortical Adenoma
• Endometrial Stromal Sarcomas

Interventions

Type	Name	Description
PROCEDURE	MRI, CT or ultrasound was permitted if MRI was contraindicated	MRI/CT/ultrasound of abdomen
PROCEDURE	Dexamethasone Supression Test	Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol
PROCEDURE	Sonogram	Sonogram of the uterus (females only)
PROCEDURE	Biopsy	Uterine endometrial biopsy (females only)
DRUG	BGG492	No study-drug was administered in this study

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-05-29
• Last updated: 2016-12-05
• Results posted: 2016-07-25

Locations

20 sites across 6 countries: United States, Germany, Hungary, Italy, Slovakia, South Korea