A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
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|ClinicalTrials.gov Identifier: NCT02582866|
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Lacosamide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label, Follow-up Study to Assess the Long-term Use of Lacosamide (Flexible Dose From 200 to 600 mg/Day) Used as Monotherapy in Subjects Who Completed SP0994 and Received Lacosamide Monotherapy Treatment|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||January 2020|
|Actual Study Completion Date :||January 2020|
Lacosamide (LCM) will be administered orally twice daily from 200 mg/day to 600 mg/day (at approximately 12 hour intervals in the morning and in the evening) in 2 divided doses. Medication must not be chewed and must be swallowed with a sufficient amount of fluid. The investigator may maintain the subject's LCM dose, decrease the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increase the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day.
Subjects stopping LCM should be tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper is permitted, if medically necessary; however, the maximum duration of tapering should not exceed 6 weeks.
- Number of Adverse Events (AEs) reported spontaneously by the subject and/or caregiver or observed by Investigator [ Time Frame: From V1 (Week 0) to Final Visit (up to Week 158) ]
- Percentage of withdrawals due to Adverse Events (AEs) [ Time Frame: From V1 (Week 0) to Final Visit (up to Week 158) ]
- Number of Serious Adverse Events (SAEs) reported spontaneously by the subject and/or caregiver or observed by Investigator [ Time Frame: From V1 (Week 0) to Final Visit (up to Week 158) ]
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): NCT02582866
|Study Director:||UCB Cares||+1 844 599 2273 (UCB)|