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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01964560
Recruitment Status : Active, not recruiting
First Posted : October 17, 2013
Last Update Posted : April 8, 2022
Sponsor:
Collaborator:
UCB Biopharma SRL
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Tracking Information
First Submitted Date  ICMJE October 14, 2013
First Posted Date  ICMJE October 17, 2013
Last Update Posted Date April 8, 2022
Actual Study Start Date  ICMJE August 2014
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE 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  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 23, 2020)
540
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2013)
500
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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  ICMJE NCT01964560
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE UCB BIOSCIENCES, Inc.
Collaborators  ICMJE UCB Biopharma SRL
Investigators  ICMJE
Study Director: UCB Cares 001 844 599 2273 (UCB)
PRS Account UCB Pharma
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP