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

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy, Partial

Intervention: Lacosamide (Drug); Levetiracetam (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: UCB Pharma

Official(s) and/or principal investigator(s):
UCB Cares, Study Director, Affiliation: +1 877 822 9493 (UCB)

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.

Clinical Details

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 design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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)

Secondary outcome:

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)

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)

Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

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

Locations and Contacts

11, Innsbruck, Austria

12, Salzburg, Austria

2, Bielefeld, Germany

1, Bonn, Germany

5, Erlangen, Germany

22, Alcorcon, Spain

20, Santiago de Compostela, Spain

Additional Information

Product Information

FDA Safety Alerts and Recalls

Starting date: July 2011
Last updated: November 20, 2014

Page last updated: August 23, 2015

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