Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures

Epilepsy Clinical Trial

Official title:

An International Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral Lacosamide (SPM 927) in Patients With Partial Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00515619
• Other study ID #: SP0774
• Secondary ID: 2004-000152-16
• Status: Completed
• Phase: Phase 3
• First received: August 13, 2007
• Last updated: June 16, 2015
• Start date: December 2004
• Est. completion date: August 2010

Study information

• Verified date: June 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationCroatia: Ministry of Health and Social CareCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyLithuania: State Medicine Control Agency - Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

• diagnosis of Epilepsy

• completion of double blind trial

Exclusion Criteria:

• taking other investigational drug than Lacosamide

• meeting withdrawal criteria from double blind trial

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Lacosamide
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

Australia,  Croatia,  Czech Republic,  Finland,  France,  Germany,  Hungary,  Lithuania,  Poland,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

References & Publications (1)

Borghs S, de la Loge C, Brabant Y, Cramer J. Sensitivity testing of the Seizure Severity Questionnaire (SSQ). Epilepsy Behav. 2014 Feb;31:281-5. doi: 10.1016/j.yebeh.2013.10.010. Epub 2013 Nov 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)	Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.	During the Treatment Period (up to 5.5 years)	No
Primary	Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)	Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.	During the Treatment Period (up to 5.5 years)	No
Primary	Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 Years)	A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.	During the Treatment Period (up to 5.5 years)	No
Secondary	Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years)	Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.; Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.	Baseline, Treatment Period (up to 5.5 years)	No
Secondary	Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years)	At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency	Treatment Period (up to 5.5 years)	No

External Links

•   FDA Safety Alerts and Recalls