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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

Primary Purpose

Epilepsy

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lacosamide
Sponsored by
UCB Biopharma SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Lacosamide, Vimpat, Epilepsy, Pediatric

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ep0151 620
  • Ep0151 621
  • Ep0151 622
  • Ep0151 361
  • Ep0151 362
  • Ep0151 650
  • Ep0151 581
  • Ep0151 582
  • Ep0151 577
  • Ep0151 224
  • Ep0151 609
  • Ep0151 602
  • Ep0151 606
  • Ep0151 682
  • Ep0151 603

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lacosamide

Arm Description

Subjects in this arm will receive various single doses of lacosamide

Outcomes

Primary Outcome Measures

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.
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.
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
Modal daily dose during the study
Modal daily dose, defined as most frequently administered dose per mg/kg/day.
Maximum daily dose during the study
Maximum daily dose, defined as the highest administered dose per mg/kg/day.

Secondary Outcome Measures

Full Information

First Posted
November 12, 2020
Last Updated
November 23, 2022
Sponsor
UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT04627285
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 28, 2020 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Lacosamide, Vimpat, Epilepsy, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lacosamide
Arm Type
Experimental
Arm Description
Subjects in this arm will receive various single doses of lacosamide
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Intervention Description
Pharmaceutical form: Oral-solution Route of administration: Oral use Subjects will receive lacosamide in a pre-specified sequence during the Treatment Period.
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs)
Description
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.
Time Frame
From visit 1 (Week 0) to the end of study visit (up to Week 213)
Title
Withdrawals from study due to TEAEs
Description
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.
Time Frame
From visit 1 (Week 0) to the end of study visit (up to Week 213)
Title
Withdrawals from study due to Serious Adverse Event (SAEs)
Description
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
Time Frame
From visit 1 (Week 0) to the end of study visit (up to Week 213)
Title
Modal daily dose during the study
Description
Modal daily dose, defined as most frequently administered dose per mg/kg/day.
Time Frame
From visit 1 (Week 0) to the end of study visit (up to Week 213)
Title
Maximum daily dose during the study
Description
Maximum daily dose, defined as the highest administered dose per mg/kg/day.
Time Frame
From visit 1 (Week 0) to the end of study visit (up to Week 213)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Ep0151 620
City
Tbilisi
Country
Georgia
Facility Name
Ep0151 621
City
Tbilisi
Country
Georgia
Facility Name
Ep0151 622
City
Tbilisi
Country
Georgia
Facility Name
Ep0151 361
City
Budapest
Country
Hungary
Facility Name
Ep0151 362
City
Budapest
Country
Hungary
Facility Name
Ep0151 650
City
Chisinau
Country
Moldova, Republic of
Facility Name
Ep0151 581
City
Bucuresti
Country
Romania
Facility Name
Ep0151 582
City
Iasi
Country
Romania
Facility Name
Ep0151 577
City
Timisoara
Country
Romania
Facility Name
Ep0151 224
City
Taipei
Country
Taiwan
Facility Name
Ep0151 609
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Ep0151 602
City
Dnipro
Country
Ukraine
Facility Name
Ep0151 606
City
Kiev
Country
Ukraine
Facility Name
Ep0151 682
City
Uzhgorod
Country
Ukraine
Facility Name
Ep0151 603
City
Vinnytsya
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://www.Vivli.org

Learn more about this trial

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

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