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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
Results First Received: November 20, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Epilepsy, Partial
Interventions: Drug: Lacosamide
Drug: Levetiracetam

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 5 sites across Austria (1 site), Germany (3 sites), and Spain (1 site).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a 1-week Screening Period, a 12-week Treatment Period (comprised of a 4-week Titration Period and an 8-week Maintenance Period), and a Taper/Safety Follow-Up Period 3 to 4 weeks in duration.

Reporting Groups
  Description
Lacosamide

commercial 50 mg (pinkish) and 100 mg (yellow) tablets

  • Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.

    8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.

  • Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time.

Participant Flow:   Overall Study
    Lacosamide  
STARTED     11  
COMPLETED     10  
NOT COMPLETED     1  
Adverse Event                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Baseline Analysis Population refers to the Safety Set (SS). The SS consists of all patients who received at least 1 dose of Lacosamide.

Reporting Groups
  Description
Lacosamide

commercial 50 mg (pinkish) and 100 mg (yellow) tablets

  • Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.

    8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.

  • Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time.

Baseline Measures
    Lacosamide  
Number of Participants  
[units: participants]
  11  
Age  
[units: years]
Mean ± Standard Deviation
  31.5  ± 5.9  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     11  
>=65 years     0  
Gender  
[units: participants]
 
Female     0  
Male     11  
Race/Ethnicity, Customized  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     0  
Black or African American     0  
Native Hawaiin or other Pacific Islander     0  
White     9  
Other/Mixed     1  
Weight  
[units: kilograms]
Mean ± Standard Deviation
  82.81  ± 16.25  
Height  
[units: centimeters]
Mean ± Standard Deviation
  178.05  ± 10.14  
Body Mass Index  
[units: kilogram per square meter]
Mean ± Standard Deviation
  25.89  ± 3.01  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   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) ]

3.  Secondary:   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) ]

4.  Secondary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The results of this study are limited due to the small sample size.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
phone: +1 877 822 9493


No publications provided


Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01375374     History of Changes
Other Study ID Numbers: SP0978, 2010-022534-84
Study First Received: May 9, 2011
Results First Received: November 20, 2014
Last Updated: November 20, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Austria: Austrian Medicines and Medical Devices Agency