Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB Biopharma S.P.R.L.
With
Parexel
Age
17–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
