A study to learn if lacosamide is safe to take over a long period of time in children with epilepsy
- Conditions
- EpilepsyMedDRA version: 21.0Level: PTClassification code: 10015037Term: Epilepsy Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2022-502639-21-00
- Lead Sponsor
- CB Biopharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 49
Participant is male or female, aged <6 years at the time of signing the Informed Consent Form (ICF) - Participant has completed participation in NCT01964560 (EP0034) or NCT00938912 (SP848) - Participant is expected to benefit from participation, in the opinion of the Investigator
- Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study - Participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol - Participant is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM) - Participant meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for EP0034 or SP848, or is experiencing an ongoing serious adverse event (SAE) - Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method