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Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide (VICTOR)

This study has been terminated.
(Slow progress despite recruitment boosting efforts e.g., expert advice obtained from leading study center Investigators; decision thus made to terminate.)
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01375374
First received: May 9, 2011
Last updated: November 20, 2014
Last verified: November 2014

May 9, 2011
November 20, 2014
July 2011
March 2013   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
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.
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) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01375374 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • change in total cholesterol level from baseline to treatment period end [ Time Frame: from day 1 (baseline) to day 84 (treatment period end) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide
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 Levetiracetam to Lacosamide as Adjunctive Treatment to Levetiracetam

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy, Partial
  • Drug: Lacosamide
    4-Week Titration Period: start dose Lacosamide (LCM) is 100 mg/day - up-titration of 100 mg/week LCM 8-Week Maintenance Period: dose can change first 4 weeks with 100 mg/week, must remain between 300 mg/day and 600 mg/day. Dose must remain stable last 4 weeks.
    Other Name: Vimpat
  • Drug: Levetiracetam
    Levetiracetam (LEV) is taken at a stable dose 30 days before study entry and is ≥ 1000 mg/day at the first visit. The LEV dose may not be changed at any time.
    Other Name: Keppra
Experimental: Lacosamide
commercial 50 mg (pinkish) and 100 mg (yellow) tablets
Interventions:
  • Drug: Lacosamide
  • Drug: Levetiracetam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male subject with diagnosis of Epilepsy with Partial-Onset Seizures
  • Subject only taking Levetiracetam in combination with Carbamazepine as adjunctive treatment for Epilepsy

Exclusion Criteria:

  • Subject is taking another Anti-Epileptic Drug (AED) than Carbamazepine (CBZ) and Levetiracetam (LEV)
  • Subject is taking lipid lowering agents
  • Subject is taking enzyme inducers
Male
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Spain
 
NCT01375374
SP0978, 2010-022534-84
No
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Cares +1 877 822 9493 (UCB)
UCB Pharma
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP