TriangleNCT02150213 · REGISTRY CONDITION SEARCH
Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2016-12-05
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).
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- 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 Names
- Procedure: MRI, CT or ultrasound was permitted if MRI was contraindicated
- Procedure: Dexamethasone Supression Test
- Procedure: Sonogram
- Procedure: Biopsy
- Drug: BGG492
- label
- BGG492
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- BGG492
- description
- MRI/CT/ultrasound of abdomen
- name
- MRI, CT or ultrasound was permitted if MRI was contraindicated
- other Names
- Magnetic Resonance Imaging Computed tomography
- type
- PROCEDURE
- arm Group Labels
- BGG492
- description
- Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol
- name
- Dexamethasone Supression Test
- type
- PROCEDURE
- arm Group Labels
- BGG492
- description
- Sonogram of the uterus (females only)
- name
- Sonogram
- other Names
- Sonogram ultrasound
- type
- PROCEDURE
- arm Group Labels
- BGG492
- description
- Uterine endometrial biopsy (females only)
- name
- Biopsy
- other Names
- Uterine Biopsy
- type
- PROCEDURE
- arm Group Labels
- BGG492
- description
- No study-drug was administered in this study
- name
- BGG492
- other Names
- Selurampanel
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
Enrollment
- count
- 59
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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)
- measure
- Incidence of Adrenal Cortical Adenomas
- time Frame
- Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212
- description
- Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)
- measure
- Incidence of Uterine Endometrial Stromal Sarcomas
- time Frame
- Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212
Full study description
- 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.
Source references
Source notices and limitations
Discovery and provenance
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- query cond
- Uterine Sarcoma
- query disease state id
- ds-uterine-sarcoma
- source file
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Preserved source evidence · Not medical advice