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

• ClinicalTrials.gov Identifier: NCT02150213
• Recruitment Status: Completed
• First Posted: May 29, 2014
• Results First Posted: July 25, 2016
• Last Update Posted: December 5, 2016
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

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).

Condition or disease	Intervention/treatment	Phase
Adrenocortical Adenoma; Endometrial Stromal Sarcomas	Procedure: MRI, CT or ultrasound was permitted if MRI was contraindicated; Procedure: Dexamethasone Supression Test; Procedure: Sonogram; Procedure: Biopsy; Drug: BGG492	Phase 2

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 (Clinical Trial)
• Actual Enrollment: 59 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: 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
• Study Start Date: August 2014
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: September 2015

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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

Procedure: MRI, CT or ultrasound was permitted if MRI was contraindicated; MRI/CT/ultrasound of abdomen; Other Name: Magnetic Resonance Imaging Computed tomography; 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); Other Name: Sonogram ultrasound; Procedure: Biopsy; Uterine endometrial biopsy (females only); Other Name: Uterine Biopsy; Drug: BGG492; No study-drug was administered in this study; Other Name: Selurampanel

Outcome Measures

Primary Outcome Measures :

1. 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)
2. 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Florida

Novartis Investigative Site

Tallahassee, Florida, United States, 32308

United States, Maryland

Novartis Investigative Site

Baltimore, Maryland, United States, 21287

United States, New Jersey

Novartis Investigative Site

Monroe Township, New Jersey, United States, 08831

United States, Texas

Novartis Investigative Site

Dallas, Texas, United States, 75230

Germany

Novartis Investigative Site

Bernau, Germany, 16321

Novartis Investigative Site

Bielefeld, Germany, 33617

Novartis Investigative Site

Bonn, Germany, 53105

Novartis Investigative Site

Kehl-Kork, Germany, 77694

Novartis Investigative Site

Ulm, Germany, 89081

Hungary

Novartis Investigative Site

Budapest, Hungary, H-1097

Novartis Investigative Site

Kecskemet, Hungary, 6000

Novartis Investigative Site

Szombathely, Hungary, 9700

Italy

Novartis Investigative Site

Firenze, FI, Italy, 50143

Novartis Investigative Site

Milano, MI, Italy, 20142

Korea, Republic of

Novartis Investigative Site

Seoul, Korea, Korea, Republic of, 03080

Novartis Investigative Site

Seoul, Korea, Korea, Republic of, 05505

Novartis Investigative Site

Seoul, Korea, Korea, Republic of, 06351

Slovakia

Novartis Investigative Site

Hlohovec, Slovak Republic, Slovakia, 92001

Novartis Investigative Site

Kosice, Slovak Republic, Slovakia, 041 90

Novartis Investigative Site

Banska Bystrica, Slovakia, 97517

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02150213 History of Changes
• Other Study ID Numbers: CBGG492A2216; 2013-003431-29 ( EudraCT Number )
• First Posted: May 29, 2014
• Results First Posted: July 25, 2016
• Last Update Posted: December 5, 2016
• Last Verified: October 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Adrenocortical Adenoma,; Endometrial Stromal sarcomas; BGG492

Additional relevant MeSH terms:

Sarcoma; Adenoma; Sarcoma, Endometrial Stromal; Adrenocortical Adenoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Complex and Mixed; Endometrial Stromal Tumors; Endometrial Neoplasms; Uterine Neoplasms; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Urogenital Neoplasms; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Dexamethasone; Dexamethasone acetate; BB 1101; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents