To Determine Tolerability and Efficacy of Long-Term Oral Lacosamide in Patients With Partial Seizures - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 30, 2007

Last Updated Date

May 6, 2009

Start Date ^†

August 2001

Current Primary Outcome Measures ^†

Safety of long-term exposure to lacosamide was evaluated with the monitoring of adverse events (AEs), ECGs, vital signs, clinical laboratory data and subject withdrawal to AE. [ Time Frame: At clinical visits every 6-months throughout the trial ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00552305 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Efficacy and maintenance of efficacy with long-term exposure to lacosamide is evaluated based on reduction in seizure frequency, 50 and 75 percent reduction in seizures, percentage of seizure-free days, and achievement of seizure-free status. [ Time Frame: At clinical visits every 6-months throughout the trial. ] [ Designated as safety issue: No ]
Clinical Global Impression of Change and Quality of Life assessment is also completed. [ Time Frame: At clinic visits every 6-months throughout the trial. ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Efficacy and maintenance of efficacy with long-term exposure to lacosamide is evaluated based on reduction in seizure frequency, 50 percent reduction in seizures, number and percentage of seizure-free days. [ Time Frame: At periodic clinic visits throughout the trial ]

Descriptive Information

Brief Title ^†

To Determine Tolerability and Efficacy of Long-Term Oral Lacosamide in Patients With Partial Seizures

Official Title ^†

An Open-Label Extension Trial to Determine Tolerability and Efficacy of Long-Term Oral SPM 927 as Adjunctive Therapy in Patients With Partial Seizures

Brief Summary

The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Partial Epilepsies

Intervention ^†

Drug: lacosamide

Study Arms / Comparison Groups

Experimental: Up to 800mg/day lacosamide (flexible dosing)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

500

Estimated Completion Date

September 2009

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Completion of parent clinical trial for treatment of partial seizures.

Exclusion Criteria:

Receiving any study drug or experimental device other than lacosamide.
Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event.

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Germany, Hungary, Lithuania, Poland, Sweden, Switzerland, United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00552305

Responsible Party

Study Director, UCB

Secondary IDs ^††

Study Sponsor ^†

UCB

Collaborators ^††

Investigators ^†

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

Information Provided By

UCB

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.