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NCT Number: NCT04627285

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

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).

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ep0151 620, Tbilisi, Georgia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacosamide

Drug
  • Pharmaceutical form: Oral-solution
  • Route of administration: Oral use

Subjects will receive lacosamide in a pre-specified sequence during the Treatment Period.

Primary outcomes

  1. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: From visit 1 (Week 0) to the end of study visit (up to Week 214.42)

    An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant 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. Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent.

  2. Percentage of Participants Who Withdrew From Study Due to TEAEs

    Time frame: From visit 1 (Week 0) to the end of study visit (up to Week 214.42)

    An AE is any untoward medical occurrence in a participant or clinical investigation participant 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. Treatment-emergent AEs were defined as those events which started on or after the date of first dose of LCM in EP0151, or events for which severity worsened on or after the date of first dose of LCM in EP0151. Adverse events which occurred within 30 days after final dose of LCM in EP0151 were considered treatment-emergent.

  3. Percentage of Participants Who Withdrew From Study Due to Serious Adverse Event (SAEs)

    Time frame: From visit 1 (Week 0) to the end of study visit (up to Week 214.42)

    A SAE is defined as results in death, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect, 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. Only participants who discontinued the study due to SAEs are reported.

  4. Modal Daily Dose During the Study

    Time frame: From visit 1 (Week 0) to the end of study visit (up to Week 214.42)

    The modal daily LCM dose in milligram per kilogram (mg/kg/day) is defined as the daily Lacosamide dose the participant received for the longest duration in EP0151.

  5. Maximum Daily Dose During the Study

    Time frame: From visit 1 (Week 0) to the end of study visit (up to Week 214.42)

    Maximum daily dose is defined as the highest total daily dose a participant received in EP0151.

Sponsors and collaborators

Lead sponsor

UCB Biopharma SRL

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2020
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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