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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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).

Detailed Summary: 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.
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome:

  • 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)
  • 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)


Original Primary Outcome:

  • Incidence of Adrenal Cortical Adenomas [ Time Frame: By approx day 7 or earlier ]
    Incidence of adrenal cortical adenomas as assessed by non-contrast MRI of the abdomen (males and females)
  • Incidence of Uterine Endometrial Stromal Sarcomas [ Time Frame: By approx day 31 or earlier ]
    Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)
  • Incidence and severity of adverse events [ Time Frame: Monitored for the duration of the study which is approx 42 days ]
    Incidence and severity of adverse events


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Novartis

Dates:
Date Received: May 15, 2014
Date Started: August 2014
Date Completion:
Last Updated: October 24, 2016
Last Verified: October 2016