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

Sponsor
UCB Biopharma SRL (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04627285
Collaborator
(none)
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Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
48 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 :
Dec 28, 2020
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of treatment-emergent adverse events (TEAEs) [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 [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) [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ep0151 620 Tbilisi Georgia
2 Ep0151 621 Tbilisi Georgia
3 Ep0151 622 Tbilisi Georgia
4 Ep0151 361 Budapest Hungary
5 Ep0151 362 Budapest Hungary
6 Ep0151 650 Chisinau Moldova, Republic of
7 Ep0151 581 Bucuresti Romania
8 Ep0151 582 Iasi Romania
9 Ep0151 577 Timisoara Romania
10 Ep0151 224 Taipei Taiwan
11 Ep0151 609 Dnipropetrovsk Ukraine
12 Ep0151 602 Dnipro Ukraine
13 Ep0151 606 Kiev Ukraine
14 Ep0151 682 Uzhgorod Ukraine
15 Ep0151 603 Vinnytsya Ukraine

Sponsors and Collaborators

  • UCB Biopharma SRL

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
UCB Biopharma SRL
ClinicalTrials.gov Identifier:
NCT04627285
Other Study ID Numbers:
  • EP0151
  • 2020-001478-30
First Posted:
Nov 13, 2020
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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 Biopharma SRL
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022