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Lacosamid-i.v.-Register (LCM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01620840
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : May 28, 2015
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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