A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment
- Registration Number
- NCT04627285
- Lead Sponsor
- UCB Biopharma SRL
- Brief Summary
The purpose of the study is to assess the long-term use of lacosamide oral solution dosed at 2 mg/kg/day to 12 mg/kg/day when administered to pediatric study participants with epilepsy who have completed NCT01964560 (EP0034) or NCT00938912 (SP848).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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 NCT01964560 (EP0034) or NCT00938912 (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
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lacosamide Lacosamide Subjects in this arm will receive various single doses of lacosamide
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs) From visit 1 (Week 0) to the end of study visit (up to Week 213) An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Withdrawals from study due to TEAEs From visit 1 (Week 0) to the end of study visit (up to Week 213) An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Withdrawals from study due to Serious Adverse Event (SAEs) From visit 1 (Week 0) to the end of study visit (up to Week 213) * Results in death
* Is life-threatening
* Requires in patient hospitalization or prolongation of existing hospitalization
* Is a congenital anomaly or birth defect
* Is an infection that requires treatment parenteral antibiotics
* Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the aboveModal daily dose during the study From visit 1 (Week 0) to the end of study visit (up to Week 213) Modal daily dose, defined as most frequently administered dose per mg/kg/day.
Maximum daily dose during the study From visit 1 (Week 0) to the end of study visit (up to Week 213) Maximum daily dose, defined as the highest administered dose per mg/kg/day.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Ep0151 606
🇺🇦Kiev, Ukraine
Ep0151 620
🇬🇪Tbilisi, Georgia
Ep0151 682
🇺🇦Uzhgorod, Ukraine
Ep0151 362
🇭🇺Budapest, Hungary
Ep0151 609
🇺🇦Dnipropetrovsk, Ukraine
Ep0151 602
🇺🇦Dnipro, Ukraine
Ep0151 361
🇭🇺Budapest, Hungary
Ep0151 603
🇺🇦Vinnytsya, Ukraine
Ep0151 581
🇷🇴Bucuresti, Romania
Ep0151 582
🇷🇴Iasi, Romania
Ep0151 621
🇬🇪Tbilisi, Georgia
Ep0151 622
🇬🇪Tbilisi, Georgia
Ep0151 224
🇨🇳Taipei, Taiwan
Ep0151 650
🇲🇩Chisinau, Moldova, Republic of
Ep0151 577
🇷🇴Timisoara, Romania