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History of Changes for Study: 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
Latest version (submitted August 1, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 12, 2020 None (earliest Version on record)
2 December 7, 2020 Study Status
3 January 11, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 January 25, 2021 Recruitment Status, Study Status and Contacts/Locations
5 January 29, 2021 Contacts/Locations and Study Status
6 February 4, 2021 Study Status and Contacts/Locations
7 March 4, 2021 Study Status and Contacts/Locations
8 March 18, 2021 Contacts/Locations and Study Status
9 April 15, 2021 Study Status and Contacts/Locations
10 April 21, 2021 Study Status
11 September 2, 2021 Study Status and Contacts/Locations
12 September 30, 2021 Contacts/Locations and Study Status
13 October 14, 2021 Study Status and Contacts/Locations
14 November 11, 2021 Study Status and Contacts/Locations
15 November 23, 2021 Study Status
16 December 9, 2021 Contacts/Locations and Study Status
17 December 17, 2021 Study Status
18 July 5, 2022 Recruitment Status, Study Status and Study Design
19 July 21, 2022 Study Status
20 August 1, 2022 Study Status and Contacts/Locations
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Study NCT04627285
Submitted Date:  November 12, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: EP0151
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
Secondary IDs: 2020-001478-30 [EudraCT Number]
Open or close this module Study Status
Record Verification: November 2020
Overall Status: Not yet recruiting
Study Start: November 2020
Primary Completion: October 2025 [Anticipated]
Study Completion: October 2025 [Anticipated]
First Submitted: November 12, 2020
First Submitted that
Met QC Criteria:
November 12, 2020
First Posted: November 13, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
November 12, 2020
Last Update Posted: November 13, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: UCB Biopharma SRL
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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).
Detailed Description:
Open or close this module Conditions
Conditions: Epilepsy
Keywords: Lacosamide
Vimpat
Epilepsy
Pediatric
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.

Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 2 Years
Maximum Age: 5 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: UCB Cares
Telephone: +1844599 Ext. 2273
Email: UCBCares@ucb.com
Study Officials: UCB Cares
Study Director
001 844 599 2273 (UCB)
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
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 Information:
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
Open or close this module References
Citations:
Links:
Available IPD/Information:

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