Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures - Tabular View

Tracking Information

First Received Date ^ICMJE

August 27, 2007

Last Updated Date

August 30, 2011

Start Date ^ICMJE

October 2004

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) [ Time Frame: During the Treatment period (maximum 6 years) ] [ Designated as safety issue: No ]
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) [ Time Frame: During the Treatment period (maximum 6 years) ] [ Designated as safety issue: No ]
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years) [ Time Frame: During the Treatment Period (maximum 6 years) ] [ Designated as safety issue: No ]
Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Original Primary Outcome Measures ^ICMJE

Safety of long-term exposure to lacosamide was evaluated with the monitoring of adverse events (AEs), ECGs, vital signs, and clinical laboratory data. [ Time Frame: At periodic clinic visits throughout the trial ]

Change History

Complete list of historical versions of study NCT00522275 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years) [ Time Frame: Baseline, Treatment period (maximum 6 years) ] [ Designated as safety issue: No ]
Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
Percentage of at Least 50% Responders During the Treatment Period (Maximum 6 Years) [ Time Frame: Treatment period (maximum 6 years) ] [ Designated as safety issue: No ]
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.

Original Secondary Outcome Measures ^ICMJE

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, and achievement of seizure-free status. [ Time Frame: At periodic clinic visits throughout the trial ]

Descriptive Information

Brief Title ^ICMJE

Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

Official Title ^ICMJE

An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 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 Type ^ICMJE

Interventional

Study Phase

Phase III

Study Design ^ICMJE

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

Condition ^ICMJE

Partial Epilepsies

Intervention ^ICMJE

Drug: lacosamide

50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial

Study Arms

Experimental: Lacosamide

Up to 800 mg/day lacosamide (flexible dosing)

Intervention: Drug: lacosamide

Publications *

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

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

308

Completion Date

October 2009

Primary Completion Date

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

Eligibility Criteria ^ICMJE

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

16 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00522275

Other Study ID Numbers ^ICMJE

SP756

Has Data Monitoring Committee

Responsible Party

( UCB, Inc. )

Study Sponsor ^ICMJE

UCB, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

Information Provided By

UCB, Inc.

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP