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Trial record 46 of 83 for:    CARBAMAZEPINE AND Cytochrome P-450 CYP3A Inducers

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

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ClinicalTrials.gov Identifier: NCT01375374
Recruitment Status : Terminated (Slow progress despite recruitment boosting efforts e.g., expert advice obtained from leading study center Investigators; decision thus made to terminate.)
First Posted : June 17, 2011
Results First Posted : November 26, 2014
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy, Partial
Interventions Drug: Lacosamide
Drug: Levetiracetam
Enrollment 11
Recruitment Details The study was conducted at 5 sites across Austria (1 site), Germany (3 sites), and Spain (1 site).
Pre-assignment Details 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.
Arm/Group Title Lacosamide
Hide Arm/Group Description

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.
Period Title: Overall Study
Started 11
Completed 10
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Lacosamide
Hide Arm/Group Description

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.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
The Baseline Analysis Population refers to the Safety Set (SS). The SS consists of all patients who received at least 1 dose of Lacosamide.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
31.5  (5.9)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
0
   0.0%
Male
11
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 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  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 11 participants
82.81  (16.25)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 11 participants
178.05  (10.14)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter
Number Analyzed 11 participants
25.89  (3.01)
1.Primary Outcome
Title 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)
Hide Description 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.
Time Frame From Day 1 (Baseline) to Day 84 (Treatment Period End)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.
Arm/Group Title Lacosamide
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: nmol/L
-12.80
(-20.3 to 4.9)
2.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame From Day 1 (Baseline) to Day 84 (Treatment Period End)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.
Arm/Group Title Lacosamide
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: Free Androgen Index
9.493
(2.39 to 26.46)
3.Secondary Outcome
Title 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)
Hide Description The change in the serum thyroid hormone free thyroxine level from Baseline to the end of the Maintenance Period was summarized descriptively by visit.
Time Frame From Day 1 (Baseline) to Day 84 (Treatment Period End)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.
Arm/Group Title Lacosamide
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: pmol/L
2.70
(1.5 to 5.5)
4.Secondary Outcome
Title Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)
Hide Description 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.
Time Frame From Day 1 (Baseline) to Day 84 (Treatment Period End)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.
Arm/Group Title Lacosamide
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: mmol/L
-0.540
(-1.46 to 0.11)
Time Frame Treatment Emergent Adverse Event were reported from Baseline until the Safety Follow-up Visit (two weeks after end of Treatment Period).
Adverse Event Reporting Description Only Treatment Emergent Adverse Events are presented.
 
Arm/Group Title Lacosamide
Hide Arm/Group Description

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.
All-Cause Mortality
Lacosamide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lacosamide
Affected / at Risk (%) # Events
Total   0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lacosamide
Affected / at Risk (%) # Events
Total   5/11 (45.45%)    
General disorders   
Fatigue * 1  1/11 (9.09%)  1
Infections and infestations   
Bronchitis * 1  1/11 (9.09%)  1
Influenza * 1  1/11 (9.09%)  1
Nervous system disorders   
Convulsion * 1  1/11 (9.09%)  1
Disturbance in attention * 1  1/11 (9.09%)  1
Paraesthesia * 1  1/11 (9.09%)  1
Partial seizures * 1  1/11 (9.09%)  1
Tremor * 1  1/11 (9.09%)  1
Psychiatric disorders   
Aggression * 1  1/11 (9.09%)  1
Vascular disorders   
Hot flush * 1  1/11 (9.09%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
The results of this study are limited due to the small sample size.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01375374     History of Changes
Other Study ID Numbers: SP0978
2010-022534-84 ( EudraCT Number )
First Submitted: May 9, 2011
First Posted: June 17, 2011
Results First Submitted: November 20, 2014
Results First Posted: November 26, 2014
Last Update Posted: August 28, 2017