Trial record 1 of 1 for:
NCT01375374
Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide (VICTOR)
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| ClinicalTrials.gov Identifier: NCT01375374 |
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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
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Sponsor:
UCB Pharma
Information provided by (Responsible Party):
UCB Pharma
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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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 11 participants |
| 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Autosomal dominant partial epilepsy with auditory features
Pyridoxal 5'-phosphate-dependent epilepsy
MedlinePlus related topics:
Hormones
| Arm | Intervention/treatment |
|---|---|
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Experimental: Lacosamide
commercial 50 mg (pinkish) and 100 mg (yellow) tablets
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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 |
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) ]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) ]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) ]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) ]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.
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| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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) |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT01375374 |
| Other Study ID Numbers: |
SP0978 2010-022534-84 ( EudraCT Number ) |
| First Posted: | June 17, 2011 Key Record Dates |
| Results First Posted: | November 26, 2014 |
| Last Update Posted: | August 28, 2017 |
| Last Verified: | July 2017 |
Keywords provided by UCB Pharma:
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Vimpat Partial seizures Carbamazepine |
Hormone levels Lipid levels Lacosamide |
Additional relevant MeSH terms:
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Epilepsies, Partial Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Lacosamide Carbamazepine Levetiracetam Physiological Effects of Drugs Anticonvulsants Nootropic Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |