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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Adrenocortical Adenoma, Endometrial Stromal Sarcomas

Intervention / Treatment
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* Procedure: MRI, CT or ultrasound was permitted if MRI was contraindicated
* Procedure: Dexamethasone Supression Test
* Procedure: Sonogram
* Procedure: Biopsy
* Drug: BGG492


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BGG492<br>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 | Procedure: MRI, CT or ultrasound was permitted if MRI was contraindicated<br>* MRI/CT/ultrasound of abdomen<br>* Other names: Magnetic Resonance Imaging Computed tomography;Procedure: Dexamethasone Supression Test<br>* Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol<br>Procedure: Sonogram<br>* Sonogram of the uterus (females only)<br>* Other names: Sonogram ultrasound;Procedure: Biopsy<br>* Uterine endometrial biopsy (females only)<br>* Other names: Uterine Biopsy;Drug: BGG492<br>* No study-drug was administered in this study<br>* Other names: Selurampanel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adrenal Cortical Adenomas | 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) | Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212 | 
| Incidence of Uterine Endometrial Stromal Sarcomas | Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females) | Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adrenocortical Adenoma,, Endometrial Stromal sarcomas, BGG492