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
  Purpose

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 Intervention Phase
Epilepsy, Partial
Drug: Lacosamide
Drug: Levetiracetam
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 11
Study Start Date: July 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375374

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:
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

Keywords provided by UCB Pharma:
Vimpat
Partial seizures
Carbamazepine
Hormone levels
Lipid levels
Lacosamide

Additional relevant MeSH terms:
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Epilepsy
Nervous System Diseases
Carbamazepine
Etiracetam
Lacosamide
Analgesics
Analgesics, Non-Narcotic
Anticonvulsants
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Nootropic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on August 02, 2015