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

NCT02150213 | Completed Phase 2 Results

• 2 other identifiers: CBGG492A22162013-003431-29
• Study Type: interventional
• Target: 59
• Locations: 6 countries
• Sites: 20

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).

Conditions

Adrenocortical Adenoma; Endometrial Stromal Sarcomas

Keywords

Adrenocortical Adenoma,; Endometrial Stromal sarcomas; BGG492

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

BGG492

EXPERIMENTAL

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; Procedure: Dexamethasone Supression Test; Procedure: Sonogram; Procedure: Biopsy; Drug: BGG492

Interventions

MRI, CT or ultrasound was permitted if MRI was contraindicated PROCEDURE

MRI/CT/ultrasound of abdomen

Also known as: Magnetic Resonance Imaging Computed tomography

BGG492

Dexamethasone Supression Test PROCEDURE

Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol

BGG492

Sonogram PROCEDURE

Sonogram of the uterus (females only)

Also known as: Sonogram ultrasound

BGG492

Biopsy PROCEDURE

Uterine endometrial biopsy (females only)

Also known as: Uterine Biopsy

BGG492

BGG492 DRUG

No study-drug was administered in this study

Also known as: Selurampanel

BGG492

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (20)

Novartis Investigative Site

Tallahassee, Florida, 32308, United States

Location

Novartis Investigative Site

Baltimore, Maryland, 21287, United States

Location

Novartis Investigative Site

Hoffman, New Jersey, 08831, United States

Location

Novartis Investigative Site

Dallas, Texas, 75230, United States

Location

Novartis Investigative Site

Bernau, 16321, Germany

Location

Novartis Investigative Site

Bielefeld, 33617, Germany

Location

Novartis Investigative Site

Bonn, 53105, Germany

Location

Novartis Investigative Site

Kehl-Kork, 77694, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

Novartis Investigative Site

Budapest, H-1097, Hungary

Location

Novartis Investigative Site

Kecskemét, 6000, Hungary

Location

Novartis Investigative Site

Szombathely, 9700, Hungary

Location

Novartis Investigative Site

Florence, FI, 50143, Italy

Location

Novartis Investigative Site

Milan, MI, 20142, Italy

Location

Novartis Investigative Site

Hlohovec, Slovak Republic, 92001, Slovakia

Location

Novartis Investigative Site

Košice, Slovak Republic, 041 90, Slovakia

Location

Novartis Investigative Site

Banská Bystrica, Slovakia, 97517, Slovakia

Location

Novartis Investigative Site

Seoul, Korea, 03080, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 05505, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 06351, South Korea

Location

MeSH Terms

Conditions

Adrenocortical Adenoma; Sarcoma, Endometrial Stromal

Interventions

Magnetic Resonance Spectroscopy; Postmortem Imaging; High-Energy Shock Waves; Biopsy; selurampanel

Condition Hierarchy (Ancestors)

Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Endometrial Stromal Tumors; Sarcoma; Neoplasms, Connective and Soft Tissue; Endometrial Neoplasms; Uterine Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Autopsy; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Results Point of Contact

• Title: Study Director
• Organization: Novartis

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 29, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 5, 2016
• Results First Posted: July 25, 2016

Record last verified: 2016-10

Locations

SL (3); KR (3); HU (3); US (4); DE (5); IT (2)