Open Label Extension Study of Lacosamide in Paediatric Subjects
Research type
Research Study
Full title
A multicentre, open-label, long-term extension study to investigate the efficacy and safety of lacosamide as adjunctive therapy in pediatric subjects with epilepsy with partial-onset seizures.
IRAS ID
142159
Contact name
Marian McGowan
Contact email
Sponsor organisation
UCB BIOSCIENCES Inc.
Eudract number
2012-005012-26
Clinicaltrials.gov Identifier
Research summary
Summary of Research
This is a phase III, open label, extension study to obtain long term safety and efficacy data of lacosamide as adjunctive therapy in paediatric subjects with epilepsy with partial-onset seizures.
Epilepsy is a common and diverse set of chronic neurological disorders and is the second most prevalent neurological disorder in the world. The condition is characterised by seizures caused by a sudden burst of excess electrical activity in the brain, which temporarily disrupts the normal message passing between brain cells.
The purpose of this study is to allow for continued dosing of lacosamide as an adjunctive therapy for children ages 1 month to less than 18 years of age with epilepsy syndromes associated with partial-onset seizures who have not achieved control of their seizures but successfully completed predecessor studies SP0969 or SP0967.
Approximately 500 subjects from SP0967 and SP0969 may be eligible to enroll in this
open-label extension study, for a maximum duration per subject of approximately 2 years. After a completion of the Transition Period in the primary study, participants will be transitioned to a dose of lacosamide twice a day according to their weight.The number of sites is dependent on the number of enrolling centers from SP0967 and SP0969. The study will be conducted in North America, Europe, Latin America, and the Asia/Pacific regions, with the possibility to expand the study to other countries and regions if deemed necessary.
Lacosamide (tablets, oral solution, and solution for iv infusion) has been approved as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older in the European Union and as adjunctive therapy in the treatment of partial-onset seizures in patients 17 years of age and older in the USA.
Summary of Results
This Plain Language Summary of Study Results will be disclosed on https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbc7HpuNAp8zv5-2FZAR9YCy6VMNbtqwp5CnAiDUowO5tjPW4JCbHIhYccwjYMSN14EOhcb8EiQ4M4Oi6qLU-2BDxALnxipIS2PCv4xy-2F1TxjnUpDrYVZ_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YILZdLSgAfAUghF9M46pzZNOLwJK91xdBatyz3246bWnx6D7m5-2BlJ3aj83OHxh4KxSjRUkK3r6ktOa3BbVvbqNzB8PsP9-2F4ZCYBbRGziWTb-2FBzA625pGWGOPj2qYfMg9VThuEl3J7WuQgSyk-2BsYgImpqDlSyrfFNprTRilfG0lPLw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ccf3d9686f18943575c2508daa22a236f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638000599108310153%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=oWE3n9Ug8%2FmhaY9Vh0R9Qxxfo4aynPr35mWMQ%2FqUqbY%3D&reserved=0 once the clinical results are made available on https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agba4yu73OCS9U-2BkKS40W1kfbzSmdWCVTTDSfM-2Bp8ODc891WAa_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YILZdLSgAfAUghF9M46pzZNX-2B5qkFJEW5xFROjui0mQWwMgoLXLWhHtyrBR5ezjTAt-2BzQqasrpMJtFygU5Ll73TP-2FuWxo7r4989xToRgmmafMbRXchkrSG-2Fz-2F0nN2YnlV5Bx6EopfekqtqzPKaWj2jR56D9GWyhPSOu-2BoH5ub8x-2Bg-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ccf3d9686f18943575c2508daa22a236f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638000599108310153%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=A8hIw1Gvqo%2BnK5R7f8BLkTpXUoJypb9dkmHFbumJyic%3D&reserved=0 and other registries.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
14/YH/0006
Date of REC Opinion
12 Mar 2014
REC opinion
Further Information Favourable Opinion