At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating MRI, CT or ultrasound was permitted if MRI was contraindicated, Dexamethasone Supression Test, and 3 other interventions for Adrenocortical Adenoma and Endometrial Stromal Sarcomas. Completed, enrolled 59 participants across 20 sites in 6 countries.
Detailed 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).
Study Details
Timeline
Interventions
MRI/CT/ultrasound of abdomen
Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol
Sonogram of the uterus (females only)
Uterine endometrial biopsy (females only)
No study-drug was administered in this study