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

October 24, 2016 updated by: Novartis Pharmaceuticals

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • 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
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, H-1097
        • Novartis Investigative Site
      • Kecskemet, Hungary, 6000
        • Novartis Investigative Site
      • Szombathely, Hungary, 9700
        • Novartis Investigative Site
  • Italy
    • FI
      • Firenze, FI, Italy, 50143
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20142
        • Novartis Investigative Site
  • Korea, Republic of
    • Korea
      • Seoul, Korea, Korea, Republic of, 05505
        • Novartis Investigative Site
      • Seoul, Korea, Korea, Republic of, 06351
        • Novartis Investigative Site
      • Seoul, Korea, Korea, Republic of, 03080
        • Novartis Investigative Site
  • Slovakia
      • Banska Bystrica, Slovakia, 97517
        • Novartis Investigative Site
    • Slovak Republic
      • Hlohovec, Slovak Republic, Slovakia, 92001
        • Novartis Investigative Site
      • Kosice, Slovak Republic, Slovakia, 041 90
        • Novartis Investigative Site
  • United States
    • Florida
      • Tallahassee, Florida, United States, 32308
        • Novartis Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Novartis Investigative Site
    • New Jersey
      • Monroe Township, New Jersey, United States, 08831
        • Novartis Investigative Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Sonogram ultrasound
Procedure: Biopsy
Uterine endometrial biopsy (females only)
Other Names:
  • Uterine Biopsy
Drug: BGG492
No study-drug was administered in this study
Other Names:
  • Selurampanel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212
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)
Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

May 15, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBGG492A2216
  • 2013-003431-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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