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

Epilepsy, Partial Clinical Trial

— VICTOR  

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 Levetiracetam to Lacosamide as Adjunctive Treatment to Levetiracetam

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01375374
• Other study ID #: SP0978
• Secondary ID: 2010-022534-84
• Status: Terminated
• Phase: Phase 3
• First received: May 9, 2011
• Last updated: July 28, 2017
• Start date: July 2011
• Est. completion date: March 2013

Study information

• Verified date: July 2017
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy, Partial

Intervention

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.
• 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.

Locations

Country	Name	City	State
Austria	11	Innsbruck
Austria	12	Salzburg
Germany	2	Bielefeld
Germany	1	Bonn
Germany	5	Erlangen
Spain	22	Alcorcon
Spain	20	Santiago de Compostela

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

Austria,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	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.	From Day 1 (Baseline) to Day 84 (Treatment Period End)
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)	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.	From Day 1 (Baseline) to Day 84 (Treatment Period End)
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)	The change in the serum thyroid hormone free thyroxine level from Baseline to the end of the Maintenance Period was summarized descriptively by visit.	From Day 1 (Baseline) to Day 84 (Treatment Period End)
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)	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.	From Day 1 (Baseline) to Day 84 (Treatment Period End)

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