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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Incidence of Uterine Endometrial Stromal Sarcomas
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Written informed consent had to be obtained before any assessment was performed;
- •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;
- •Total exposure to BGG492 treatment in Study BGG492A2207 and/or BGG492A2212 had to have been greater than 28 days
- •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
Arms & Interventions
BGG492
This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
Intervention: MRI, CT or ultrasound was permitted if MRI was contraindicated (Procedure)
BGG492
This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
Intervention: Dexamethasone Supression Test (Procedure)
BGG492
This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
Intervention: Sonogram (Procedure)
BGG492
This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
Intervention: Biopsy (Procedure)
BGG492
This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
Intervention: BGG492 (Drug)
Outcomes
Primary Outcomes
Incidence of Uterine Endometrial Stromal Sarcomas
Time Frame: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212
Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)
Incidence of Adrenal Cortical Adenomas
Time Frame: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212
Incidence of adrenal cortical adenomas as assessed by non-contrast MRI of the abdomen (CT or ultrasound of the abdomen was permitted if MRI was contraindication)
Secondary Outcomes
No secondary outcomes reported