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

• ClinicalTrials.gov Identifier: NCT01375374
• Recruitment Status: Terminated
• First Posted: June 17, 2011
• Results First Posted: November 26, 2014
• Last Update Posted: August 28, 2017
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Epilepsy, Partial	Drug: Lacosamide; Drug: Levetiracetam	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: July 2011
• Actual Primary Completion Date: March 2013
• Actual Study Completion Date: March 2013

Arms and Interventions

Arm

Intervention/treatment

Experimental: Lacosamide; commercial 50 mg (pinkish) and 100 mg (yellow) tablets

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Austria

11

Innsbruck, Austria

12

Salzburg, Austria

Germany

2

Bielefeld, Germany

1

Bonn, Germany

5

Erlangen, Germany

Spain

22

Alcorcon, Spain

20

Santiago de Compostela, Spain

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Cares; +1 877 822 9493 (UCB)

More Information

Additional Information:

Product Information 

FDA Safety Alerts and Recalls 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Elger CE, Rademacher M, Brandt C, Elmoufti S, Dedeken P, Eckhardt K, Tennigkeit F, De Backer M. Changes in hormone and lipid levels in male patients with focal seizures when switched from carbamazepine to lacosamide as adjunctive treatment to levetiracetam: A small phase IIIb, prospective, multicenter, open-label trial. Epilepsy Behav. 2016 Sep;62:1-5. doi: 10.1016/j.yebeh.2016.05.023. Epub 2016 Jul 15.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT01375374
• Other Study ID Numbers: SP0978; 2010-022534-84 ( EudraCT Number )
• First Posted: June 17, 2011
• Results First Posted: November 26, 2014
• Last Update Posted: August 28, 2017
• Last Verified: July 2017

Keywords provided by UCB Pharma:

Vimpat; Partial seizures; Carbamazepine; Hormone levels; Lipid levels; Lacosamide

Additional relevant MeSH terms:

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Lacosamide; Levetiracetam; Anticonvulsants; Nootropic Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action