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

Epilepsy Clinical Trial

Official title:

A Multicenter, Open-Label, Follow-Up Study to Assess the Long-Term Use of Oral Lacosamide in Study Participants Who Completed EP0034 or SP848 and Received Lacosamide Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04627285
• Other study ID #: EP0151
• Secondary ID: 2020-001478-3020
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 28, 2020
• Est. completion date: July 31, 2025

Study information

• Verified date: November 2023
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Lacosamide
Pharmaceutical form: Oral-solution Route of administration: Oral use Subjects will receive lacosamide in a pre-specified sequence during the Treatment Period.

Locations

Country	Name	City	State
Georgia	Ep0151 620	Tbilisi
Georgia	Ep0151 621	Tbilisi
Georgia	Ep0151 622	Tbilisi
Hungary	Ep0151 361	Budapest
Hungary	Ep0151 362	Budapest
Moldova, Republic of	Ep0151 650	Chisinau
Romania	Ep0151 581	Bucuresti
Romania	Ep0151 582	Iasi
Romania	Ep0151 577	Timisoara
Taiwan	Ep0151 224	Taipei
Ukraine	Ep0151 602	Dnipro
Ukraine	Ep0151 609	Dnipropetrovsk
Ukraine	Ep0151 606	Kiev
Ukraine	Ep0151 682	Uzhgorod
Ukraine	Ep0151 603	Vinnytsya

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

Georgia,  Hungary,  Moldova, Republic of,  Romania,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs)	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.	From visit 1 (Week 0) to the end of study visit (up to Week 213)
Primary	Withdrawals from study due to TEAEs	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.	From visit 1 (Week 0) to the end of study visit (up to Week 213)
Primary	Withdrawals from study due to Serious Adverse Event (SAEs)	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 above	From visit 1 (Week 0) to the end of study visit (up to Week 213)
Primary	Modal daily dose during the study	Modal daily dose, defined as most frequently administered dose per mg/kg/day.	From visit 1 (Week 0) to the end of study visit (up to Week 213)
Primary	Maximum daily dose during the study	Maximum daily dose, defined as the highest administered dose per mg/kg/day.	From visit 1 (Week 0) to the end of study visit (up to Week 213)