A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
Completed · Phase 3
Conditions studied: Epilepsy
In brief
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.
Key facts
- Study ID
- NCT01964560
- Run by
- UCB BIOSCIENCES, Inc.
- People needed
- 540
- Starts
- 2014-08-13
- Expected to finish
- 2022-04-13
- Last updated by the study team
- 2022-10-25
Who can join
Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Subject has completed the Transition Period of SP0967 [NCT02477839] or SP0969 [NCT01921205] for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy
- Subject is expected to benefit from participation, in the opinion of the investigator
- 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
- Subject is male or female aged 1 month to ≤17 years
- Subject has a diagnosis of epilepsy with partial-onset seizures
You may not qualify if…
- Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
- Subject meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for SP0967 or SP0969, or is experiencing an ongoing serious adverse event (SAE)
- For subjects ≥6 years of age, subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1
- Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception
Where it is running
- Ep0034 105 — Orlando, Florida, United States
- Ep0034 117 — Tampa, Florida, United States
- Ep0034 124 — Lexington, Kentucky, United States
- Ep0034 115 — Henderson, Nevada, United States
- Ep0034 120 — Lebanon, New Hampshire, United States
- Ep0034 102 — Charlotte, North Carolina, United States
- Ep0034 640 — Springfield, Oregon, United States
- Ep0034 129 — Dallas, Texas, United States
- Ep0034 630 — San Antonio, Texas, United States
- Ep0034 114 — Seattle, Washington, United States
- Ep0034 143 — Ciudad Autonoma de Buenos AIRE, Argentina
- Ep0034 142 — Córdoba, Argentina
- Ep0034 200 — Melbourne, Australia
- Ep0034 203 — Parkville, Australia
- Ep0034 205 — South Brisbane, Australia
- Ep0034 304 — Brussels, Belgium
- Ep0034 158 — Passo Fundo, Brazil
- Ep0034 150 — São Paulo, Brazil
- Ep0034 154 — São Paulo, Brazil
- Ep0034 310 — Plovdiv, Bulgaria
- Ep0034 530 — Beijing, China
- Ep0034 535 — Changchun, China
- Ep0034 532 — Chongqing, China
- Ep0034 536 — Nanchang, China
- Ep0034 638 — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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