Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01832038|
Recruitment Status : Completed
First Posted : April 15, 2013
Last Update Posted : October 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Partial-onset Seizures||Drug: Lacosamide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||473 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 26, 2013|
|Actual Primary Completion Date :||July 31, 2019|
|Actual Study Completion Date :||July 31, 2019|
Lacosamide treatment of 100 - 400 mg/day for long-term
Strength: Lacosamide (LCM) 50 mg, LCM 100 mg
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.
Other Name: Vimpat
- 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 ]
- 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 ]Baseline is defined as the Baseline Period of study EP0008 [NCT01710657].
- 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 ]A responder is defined as a subject that experiences a ≥ 50 % reduction from Baseline in partial-onset seizure frequency per 28 days. Baseline is defined as the Baseline Period of study EP0008 [NCT01710657].
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832038
|Study Director:||UCB Cares||+1 844 599 2273 (UCB)|