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Completed

NCT Number: NCT02150213

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Bernau, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI, CT or ultrasound was permitted if MRI was contraindicated

Procedure

MRI/CT/ultrasound of abdomen

Other names: Magnetic Resonance Imaging Computed tomography

Dexamethasone Supression Test

Procedure

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

Sonogram

Procedure

Sonogram of the uterus (females only)

Other names: Sonogram ultrasound

Biopsy

Procedure

Uterine endometrial biopsy (females only)

Other names: Uterine Biopsy

BGG492

Drug

No study-drug was administered in this study

Other names: Selurampanel

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 29, 2014
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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