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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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