A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures

• ClinicalTrials.gov Identifier: NCT01964560
• Recruitment Status: Active, not recruiting
• First Posted: October 17, 2013
• Last Update Posted: April 8, 2022
• Sponsor: UCB BIOSCIENCES, Inc.
• Collaborator: UCB Biopharma SRL
• Information provided by (Responsible Party): UCB Pharma ( UCB BIOSCIENCES, Inc. )

Tracking Information

• First Submitted Date: October 14, 2013
• First Posted Date: October 17, 2013
• Last Update Posted Date: April 8, 2022
• Actual Study Start Date: August 2014
• Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 29, 2021)

• Percentage of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: From Week 0 to the End of Safety Follow-Up (approximately 104 weeks) ]
  An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent is defined as starting on or after the date of first dose of lacosamide (LCM) in EP0034, and within 30 days of last dose.
• Percentage of participants with TEAEs leading to study discontinuation [ Time Frame: From Week 0 to the End of Safety Follow-Up (approximately 104 weeks) ]
  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. AEs leading to study discontinuation. Treatment-emergent is defined as starting on or after the date of first dose of lacosamide (LCM) in EP0034, and within 30 days of last dose.

Original Primary Outcome Measures (submitted: October 14, 2013)

• Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) during the study [ Time Frame: Baseline to the End of Treatment (approximately 96 weeks) ]
• Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) leading to discontinuation from the study [ Time Frame: Baseline to End of Treatment (approximately 96 weeks) ]

Current Secondary Outcome Measures (submitted: July 29, 2021)

Percentage of seizure-free days during the study [ Time Frame: From Week 0 to End of Treatment Period (up to Week 96) ]

Percentage of seizure-free days will be measured using data obtained from subject diaries from EP0034 and will be presented for the overall Treatment Period only.

Original Secondary Outcome Measures (submitted: October 14, 2013)

• Percentage of Seizure Free Days at the End of Year 1 [ Time Frame: End of Year 1 of the Study (approximately 52 weeks) ]
• Percentage of Seizure Free Days at the End of Year 2 [ Time Frame: End of Year 2 of the Study (approximately 96 weeks) ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
• Official Title: A Multicenter, Open-label, Long-term Extension Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Pediatric Subjects With Epilepsy With Partial-Onset Seizures
• Brief Summary: The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Epilepsy

Intervention

• Drug: Lacosamide

  Pharmaceutical form: oral solution

  Concentration: 1 mg/kg - 6 mg/kg BID (2 mg/kg/day - 12 mg/ kg/day)

  Route of administration: oral use

  Other Name: VIMPAT
• Drug: Lacosamide

  Pharmaceutical form: tablet

  Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day)

  Route of administration: oral use

  Other Name: VIMPAT

Study Arms

Experimental: Lacosamide

In the first week after enrollment into EP0034 subjects will be dosed according to their weight:

• Lacosamide (LCM) 10 mg/kg/day (oral solution) for subjects weighing <30 kg
• LCM 6 mg/kg/day (oral solution) for subjects weighing ≥30 kg to <50 kg
• LCM 300 mg/day (tablets) for subjects weighing ≥50 kg

After 1 week the investigator may adjust the LCM dose during the Treatment Period based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.

Interventions:

• Drug: Lacosamide
• Drug: Lacosamide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: June 23, 2020): 540
• Original Estimated Enrollment (submitted: October 14, 2013): 500
• Estimated Study Completion Date: April 2022
• Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors
• Subject has completed the Transition Period of SP0967 [NCT02477839] or SP0969 [NCT01921205] for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy
• Subject is expected to benefit from participation, in the opinion of the investigator
• Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator
• Subject is male or female aged 1 month to ≤17 years
• Subject has a diagnosis of epilepsy with partial-onset seizures

Exclusion Criteria:

• Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
• Subject meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for SP0967 or SP0969, or is experiencing an ongoing serious adverse event (SAE)
• For subjects ≥6 years of age, subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1
• Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Month to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Belgium, Brazil, Bulgaria, China, Colombia, Croatia, Czechia, Estonia, France, Georgia, Greece, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Moldova, Republic of, Montenegro, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Taiwan, Thailand, Ukraine, United Kingdom, United States
• Removed Location Countries: Czech Republic

Administrative Information

• NCT Number: NCT01964560
• Other Study ID Numbers: EP0034; 2012-005012-26 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
• URL: https://www.Vivli.org

• Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
• Study Sponsor: UCB BIOSCIENCES, Inc.
• Collaborators: UCB Biopharma SRL

Investigators

• Study Director: UCB Cares; 001 844 599 2273 (UCB)

• PRS Account: UCB Pharma
• Verification Date: April 2022