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

NCT01375374 | Terminated Phase 3 Results

• 2 other identifiers: SP09782010-022534-84
• Study Type: interventional
• Target: 11
• Locations: 3 countries
• Sites: 7

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.

Conditions

Epilepsy, Partial

Keywords

Vimpat; Partial seizures; Carbamazepine; Hormone levels; Lipid levels; Lacosamide

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  From Day 1 (Baseline) to Day 84 (Treatment Period End)

Secondary Outcomes (3)

• 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)

  From Day 1 (Baseline) to Day 84 (Treatment Period End)

• 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)

  From Day 1 (Baseline) to Day 84 (Treatment Period End)

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

  From Day 1 (Baseline) to Day 84 (Treatment Period End)

Study Arms (1)

Lacosamide

EXPERIMENTAL

commercial 50 mg (pinkish) and 100 mg (yellow) tablets

Drug: Lacosamide; Drug: Levetiracetam

Interventions

Lacosamide DRUG

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.

Also known as: Vimpat

Lacosamide

Levetiracetam DRUG

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.

Also known as: Keppra

Lacosamide

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male subject with diagnosis of Epilepsy with Partial-Onset Seizures
• Subject only taking Levetiracetam in combination with Carbamazepine as adjunctive treatment for Epilepsy

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (7)

11

Innsbruck, Austria

Location

12

Salzburg, Austria

Location

2

Bielefeld, Germany

Location

1

Bonn, Germany

Location

5

Erlangen, Germany

Location

22

Alcorcón, Spain

Location

20

Santiago de Compostela, Spain

Location

Related Publications (1)

• 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.

  PMID: 27423106 DERIVED

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Epilepsies, Partial; Seizures

Interventions

Lacosamide; Levetiracetam

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The results of this study are limited due to the small sample size.

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB

+1 877 822 9493

Study Officials

• UCB Cares

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: June 17, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 28, 2017
• Results First Posted: November 26, 2014

Record last verified: 2017-07

Locations

DE (3); ES (2); AU (2)