Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide
NCT ID: NCT01375374
Last Updated: 2017-08-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
11 participants
INTERVENTIONAL
2011-07-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lacosamide
commercial 50 mg (pinkish) and 100 mg (yellow) tablets
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject only taking Levetiracetam in combination with Carbamazepine as adjunctive treatment for Epilepsy
Exclusion Criteria
* Subject is taking lipid lowering agents
* Subject is taking enzyme inducers
18 Years
45 Years
MALE
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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11
Innsbruck, , Austria
12
Salzburg, , Austria
2
Bielefeld, , Germany
1
Bonn, , Germany
5
Erlangen, , Germany
22
Alcorcón, , Spain
20
Santiago de Compostela, , Spain
Countries
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References
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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.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2010-022534-84
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP0978
Identifier Type: -
Identifier Source: org_study_id
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