Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT02582866
Eligibility Criteria:
Inclusion Criteria:
* An Institutional Review Board /Institutional Ethics Committee approved written Informed Consent Form (ICF) is signed and dated by the subject or by the parent(s) or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors
* Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgment of the investigator
* Subject has completed the Termination Visit of SP0994 \[NCT01465997\] and has been treated with lacosamide monotherapy
Exclusion Criteria:
* Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
* Subject experienced a seizure at the 3rd target dose (i.e. LCM 600 mg/day) during SP0994
* Subject required another Anti Epileptic Drug (AED) for the treatment of seizures
* Subject meets a "must" withdrawal criteria for SP0994
* Subject is experiencing an ongoing Serious Adverse Event from SP0994
* Female subject who is pregnant or nursing, and/or a woman of childbearing potential who is not surgically sterile, 2 year postmenopausal or does not practice one highly effective method of contraception, unless sexually abstinent, for the duration of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Study:
NCT02582866
Study Brief:
Protocol Section:
NCT02582866