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

Phase 3

Completed

• Conditions: Partial Epilepsies
• Interventions: Drug: lacosamide

• Registration Number: NCT00522275
• Lead Sponsor: UCB BIOSCIENCES, Inc.

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

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2007-08-27
• Study First Submitted QC: 2007-08-27
• Study First Posted: 2007-08-29
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2010-10-28
• Results First Submitted QC: 2010-10-28
• Results First Posted: 2010-11-22
• Status Verified: 2017-07
• Last Update Submitted: 2018-06-20
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lacosamide	lacosamide	Up to 800 mg/day lacosamide (flexible dosing)

Primary Outcome Measures

Name	Time	Method
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)	During the Treatment Period (Maximum 6 years)	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)	During the Treatment Period (Maximum 6 years)	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)	During the Treatment Period (Maximum 6 years)	Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Secondary Outcome Measures

Name	Time	Method
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)	Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)	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)	Treatment Period (Maximum 6 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.