Overview

This trial is active, not recruiting.

Conditions epilepsy, partial-onset seizures
Treatment lacosamide
Phase phase 3
Sponsor UCB Pharma SA
Collaborator UCB Japan Co. Ltd.
Start date March 2013
End date September 2018
Trial size 473 participants
Trial identifier NCT01832038, EP0009

Summary

The purpose of this trial is to evaluate the safety and tolerability of long-term administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with Epilepsy who have completed the Treatment and Transition Period of EP0008 [NCT01710657]

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Lacosamide treatment of 100 - 400 mg/day for long-term
lacosamide Vimpat
Strength: Lacosamide (LCM) 50 mg, LCM 100 mg Formulation: Tablet Frequency: twice daily during the study period (until the date of approval) At the completion of EP0008 [NCT01710657], all subjects who choose to enroll in EP0009 will be taking a dose of Lacosamide 200 mg/day. At the beginning of EP0009, the investigator may maintain the LCM dose or increase or decrease the dose. During the Treatment Period, the investigator will be allowed to increase or decrease the dose of LCM to optimize tolerability and seizure reduction. The LCM dose may be decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day.

Primary Outcomes

Measure
Adverse Events (AEs) reported spontaneously by the subject or observed by the investigator from Baseline until the End of Study Visit
time frame: From Visit 1 (Week 0) up to approximately Week 223
Subject withdrawals due to Adverse Events from Baseline until the End of Study Visit
time frame: From Visit 1 (Week 0) up to approximately Week 223

Secondary Outcomes

Measure
Percent change in Partial-onset Seizure frequency per 28 days from Baseline until the End of Study Visit
time frame: From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 223
50 % response rate from Baseline of study EP0008 [NCT01710657] until the End of Study Visit
time frame: From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 223

Eligibility Criteria

Male or female participants from 16 years up to 70 years old.

Inclusion Criteria: - Subject has completed the Treatment and Transition Period of EP0008 [NCT01710657] Exclusion Criteria: - Subjects who withdrew from EP0008 [NCT01710657]

Additional Information

Official title A Multi-center, Open-label, Uncontrolled, Long-term, Extension Study to Evaluate the Safety and Efficacy of Lacosamide as Adjunctive Therapy in Japanese and Chinese Adults With Partial-onset Seizures With or Without Secondary Generalization
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by UCB Pharma.