Clinical Trial: Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Multicenter, Open-label, Single-arm Study to Evaluate Hormone and Lipid Levels in Male Subjects With Partial-onset Seizures After a Switch of Treatment From Carbamazepine as Adjunctive Treatment to Le

Brief Summary: The purpose of the trial is to investigate whether changes in lipids and hormonal parameters can be observed in blood when Carbamazepine treatment is replaced with Lacosamide treatment, while Levetiracetam treatment remains unchanged.

Detailed Summary:
Sponsor: UCB Pharma

Current Primary Outcome: Change in Serum Sex Hormone Binding Globulin (SHBG) From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) [ Time Frame: From Day 1 (Baseline) to Day 84 (Treatment Period End) ]

Due to premature termination of enrollment prior to achieving the planned sample size (a total of 28 subjects), this primary safety variable was assessed for descriptive purposes only. A negative value indicates an improvement.


Original Primary Outcome: change in serum sex hormone binding globulin (SHBG) from baseline to treatment period end [ Time Frame: From Day 1 (Baseline) to Day 84 (Treatment Period End) ]

Current Secondary Outcome:

  • Change in Sex Hormone Calculated Free Androgen Index Levels From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) [ Time Frame: From Day 1 (Baseline) to Day 84 (Treatment Period End) ]
    The change in sex hormone calculated free androgen index (100 x Testosterone/sex hormone binding globulin) levels from Baseline to the end of Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement.
  • Change in Serum Thyroid Hormone Free Thyroxine Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) [ Time Frame: From Day 1 (Baseline) to Day 84 (Treatment Period End) ]
    The change in the serum thyroid hormone free thyroxine level from Baseline to the end of the Maintenance Period was summarized descriptively by visit.
  • Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period) [ Time Frame: From Day 1 (Baseline) to Day 84 (Treatment Period End) ]
    The change in total cholesterol levels from Baseline to the end of the Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement.


Original Secondary Outcome:

  • change in sex hormone calculated free androgen index levels from baseline to treatment period end [ Time Frame: From Day 1 (Baseline) to Day 84 (Treatment Period End) ]
    sex hormone calculated free androgen index level = 100x(testosterone/SHBG)
  • change in serum thyroid hormone free thyroxine level from baseline to treatment period end [ Time Frame: From Day 1 (Baseline) to Day 84 (Treatment Period End) ]
  • change in total cholesterol level from baseline to treatment period end [ Time Frame: From Day 1 (Baseline) to Day 84 (Treatment Period End) ]


Information By: UCB Pharma

Dates:
Date Received: May 9, 2011
Date Started: July 2011
Date Completion:
Last Updated: November 20, 2014
Last Verified: November 2014