Clinical trial NCT01375374: Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Epilepsy, Partial
Keywords: Vimpat
Partial seizures
Carbamazepine
Hormone levels
Lipid levels
Lacosamide
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-06-17
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: From Day 1 (Baseline) to Day 84 (Treatment Period End)
Secondary outcomes:
measure: 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)
timeFrame: From Day 1 (Baseline) to Day 84 (Treatment Period End)
measure: 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)
timeFrame: From Day 1 (Baseline) to Day 84 (Treatment Period End)
measure: Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)
timeFrame: From Day 1 (Baseline) to Day 84 (Treatment Period End)
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: 11
city: Salzburg
country: Austria
facility: 12
city: Bielefeld
country: Germany
facility: 2
city: Bonn
country: Germany
facility: 1
city: Erlangen
country: Germany
facility: 5
city: Alcorcon
country: Spain
facility: 22
city: Santiago de Compostela
country: Spain
facility: 20
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: 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.