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Trial record 2 of 2 for:    NCT01964560

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 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: NCT04627285
Recruitment Status : Enrolling by invitation
First Posted : November 13, 2020
Last Update Posted : December 20, 2021
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( 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).

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Lacosamide Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 28, 2020
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Lacosamide

Arm Intervention/treatment
Experimental: Lacosamide
Subjects in this arm will receive various single doses of lacosamide
Drug: Lacosamide
  • Pharmaceutical form: Oral-solution
  • Route of administration: Oral use

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





Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: 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.

  2. Withdrawals from study due to TEAEs [ Time Frame: 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.

  3. Withdrawals from study due to Serious Adverse Event (SAEs) [ Time Frame: 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 above

  4. Modal daily dose during the study [ Time Frame: 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.

  5. Maximum daily dose during the study [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04627285


Locations
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Georgia
Ep0151 620
Tbilisi, Georgia
Ep0151 621
Tbilisi, Georgia
Ep0151 622
Tbilisi, Georgia
Hungary
Ep0151 361
Budapest, Hungary
Ep0151 362
Budapest, Hungary
Moldova, Republic of
Ep0151 650
Chisinau, Moldova, Republic of
Romania
Ep0151 581
Bucuresti, Romania
Ep0151 582
Iaşi, Romania
Ep0151 577
Timişoara, Romania
Taiwan
Ep0151 224
Taipei, Taiwan
Ukraine
Ep0151 602
Dnipropetrovs'k, Ukraine
Ep0151 609
Dnipropetrovs'k, Ukraine
Ep0151 606
Kiev, Ukraine
Ep0151 603
Vinnytsya, Ukraine
Ep0151 682
Úzhgorod, Ukraine
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT04627285    
Other Study ID Numbers: EP0151
2020-001478-30 ( EudraCT Number )
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: December 20, 2021
Last Verified: December 2021
Individual Participant Data (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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Lacosamide
Vimpat
Epilepsy
Pediatric
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lacosamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action