Lacosamid-i.v.-Register (LCM)

• ClinicalTrials.gov Identifier: NCT01620840
• Recruitment Status: Completed
• First Posted: June 15, 2012
• Last Update Posted: May 28, 2015
• Sponsor: University of Schleswig-Holstein
• Information provided by (Responsible Party): Ulrich Stephani, University of Schleswig-Holstein

Tracking Information

• First Submitted Date: June 13, 2012
• First Posted Date: June 15, 2012
• Last Update Posted Date: May 28, 2015
• Study Start Date: June 2011
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Lacosamid-i.v.-Register
• Official Title: Lacosamid-i.v.-Register
• Brief Summary: Lacosamide is a new antiepileptic drug (AED) marketed as Vimpat with three different formulations, tablets, oral syrup and a solution for intravenous infusion. Lacosamide is approved as adjunctive therapy in epilepsy patients with partial onset seizures with or without secondary generalization. The i.v. solution is used in patients in which oral administration is not possible or adequate. Bioequivalence with oral tablets and safety could be demonstrated in healthy volunteers and in patients switched from tablets to Lacosamide i.v. solution. A recently published study demonstrates the feasibility of single loading doses up to 300 mg. The aim of this Lacosamide i.v. registry is to collect systematically data on the safety, tolerability and administration procedures when Lacosmide i.v. is used in routine daily clinical practice, mainly in hospitals. These data will help treating physicians to optimize the use of Lacosamide i.v. in clinical routine.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients who are treated with Lacosamide i.v.-solution in routine clinical practice.
• Condition: Epilepsy With Partial Onset Seizures With or Without Secondary Generalization

Intervention

Drug: Lacosamide 10mg/ml

intravenous administration up to 10 days

Other Name: VimpatⓇ

Study Groups/Cohorts

Lacosamid-i.v. treatment

Intervention: Drug: Lacosamide 10mg/ml

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 27, 2015): 130
• Original Estimated Enrollment (submitted: June 13, 2012): 200
• Actual Study Completion Date: November 2013
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• before any data are collected for any patient in this registry an ehtical committee must be notified of the registry and written data consent must be properly executed and documented

Exclusion Criteria:

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT01620840
• Other Study ID Numbers: UCB-LCM-2011
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Ulrich Stephani, University of Schleswig-Holstein
• Study Sponsor: University of Schleswig-Holstein
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ulrich Stephani, Prof.Dr.med.; University hospital Schleswig-Holstein, Germany

• PRS Account: University of Schleswig-Holstein
• Verification Date: May 2015