A Multicenter, 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
- Children’s Medical Center (Dallas, Plano, Southlake)
Susan Arnold, M.D.
approximately 500 subjects from SP0967 and SP0969 may be eligible to enroll in the open-label extension study, for a maximum duration per subject of approximately 2 years. The number of sites depends 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, and possibly to other countries and regions if deemed necessary.
once Transition Period in the primary study, subjects will have been transitioned to a dose of LCM according to their weight. Subjects will receive LCM 10mg/kg/day (oral solution) for subjects weighing [Less Than]30kg, LCM 6mg/kg/day (oral solution) for subjects weighing [GreaterThanorequalTo]30kg to [Less Than]50kg, and LCM 300mg/day (tablets) for subjects weighing [GreaterThanorequalTo]50kg during at least their first week in the Treatment Period of eP0034. after 1 week in eP0034, the investigator may adjust the LCM dose during the Treatment Period based on clinical judgment within a range of 2mg/kg/day to 12mg/kg/day for the oral solution and 100mg/day to 600mg/day for the tablets.
The study medication is LCM in either the oral solution formulation or tablet formulation. Subjects may take either oral solution or tablets during the Treatment Period, regardless of their weight. Lacosamide will be administered twice daily (bid) at approx. 12-hour intervals, once in the morning and once in the evening, in equally divided doses. The oral solution formulation will be measured and administered via a dosing syringe.
During the Treatment Period, study visits are scheduled at Weeks 0, 4, 8, 12, 20, 28, 36, 44, 52, 60, 72, 84, and 96. Telephone contacts are scheduled at Weeks 2, 6, 10, 16, 24, 32, 40, 48, 56, 66, and 78. Subjects who withdraw from treatment during the study should taper off LCM if the following doses are achieved: LCM [GreaterThanorequalTo]3mg/kg/day (oral solution) for subjects receiving LCM oral solution, or LCM [GreaterThanorequalTo]150mg/day (tablet) for subjects taking tablets; lower doses will not require a taper. an early Termination Visit must be completed for all subjects who prematurely discontinue from the study. Subjects who complete the study or withdraw prematurely from the study, and who discontinue use of LCM, should complete a Safety Follow-up Visit 2 weeks ((+-)2 days) after the final dose of LCM. a Safety Follow-up Telephone Contact will be made 30 days (-1/+3 days) after the final dose of LCM. at the completion of the study, investigators should discuss treatment options with the subject and/or their legal representative(s) to best manage the subject's epilepsy. Taper of LCM may not be required for some subjects who complete the study or withdraw from the study prematurely, depending on the treatment option selected by the investigator in consultation with the subject and/or legal representative(s).
Safety will be evaluated based on the occurrence of adverse events (aes), the results of periodic clinical laboratory tests, electrocardiograms (eCGs), physical and neurological examinations, vital signs (blood pressure and pulse rate) monitoring, and body weight and height. The efficacy variables will include the percentage of seizure-free days during the study.
These efficacy variables will be computed for all subjects in eP0034: achievement of seizure-free status (no seizure) during the study for total partial-onset seizure and per seizure type (simple partial, complex partial or secondarily generalized), Clinical Global impression of Change, and Caregiver's Global impression of Change.
other evaluations are: behavioral and cognition assessments (achenbach Child Behavior Checklist [CBCL], Behavior Rating inventory of executive Function [BRieF[RegisteredTM]]/BRieF Preschool Version [BRieF[RegisteredTM]-P], and Bayley Scales of infant and Toddler Development, Third edition [Bayley-iii[RegisteredTM]] for subjects enrolled in english-speaking countries), quality of life assessments (Pediatric Quality of Life inventory [PedsQL[TM]]), plasma concentrations of LCM, and health care resource use.
To be eligible to participate in this study, all of the following criteria must be met:
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written
Informed Consent form (ICF) is signed and dated by the subject or legal representative. The
ICF or a specific Assent form, where required, will be signed and dated by minors.
2. Subject has completed the Transition Period of SP0967 or SP0969 for the treatment of
uncontrolled partial-onset seizures in pediatric epilepsy.
3. Subject is expected to benefit from participation, in the opinion of the investigator.
4. Subject/legal representative is considered reliable and capable of adhering to the protocol
(eg, able to understand and complete diaries), visit schedule, and medication intake according
to the judgment of the investigator.