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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

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lacosamide
Lacosamide
Sponsored by
UCB BIOSCIENCES, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Lacosamide, Vimpat, UCB, Epilepsy, Partial-Onset Seizures, Pediatric

Eligibility Criteria

1 Month - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ep0034 638
  • Ep0034 105
  • Ep0034 117
  • Ep0034 124
  • Ep0034 115
  • Ep0034 120
  • Ep0034 102
  • Ep0034 640
  • Ep0034 129
  • Ep0034 630
  • Ep0034 114
  • Ep0034 143
  • Ep0034 142
  • Ep0034 200
  • Ep0034 203
  • Ep0034 205
  • Ep0034 304
  • Ep0034 158
  • Ep0034 150
  • Ep0034 154
  • Ep0034 310
  • Ep0034 530
  • Ep0034 535
  • Ep0034 532
  • Ep0034 536
  • Ep0034 531
  • Ep0034 537
  • Ep0034 171
  • Ep0034 613
  • Ep0034 610
  • Ep0034 612
  • Ep0034 321
  • Ep0034 320
  • Ep0034 322
  • Ep0034 323
  • Ep0034 331
  • Ep0034 330
  • Ep0034 346
  • Ep0034 344
  • Ep0034 620
  • Ep0034 621
  • Ep0034 622
  • Ep0034 623
  • Ep0034 542
  • Ep0034 361
  • Ep0034 362
  • Ep0034 363
  • Ep0034 364
  • Ep0034 368
  • Ep0034 360
  • Ep0034 367
  • Ep0034 366
  • Ep0034 374
  • Ep0034 397
  • Ep0034 380
  • Ep0034 398
  • Ep0034 381
  • Ep0034 393
  • Ep0034 383
  • Ep0034 392
  • Ep0034 395
  • Ep0034 386
  • Ep0034 211
  • Ep0034 210
  • Ep0034 212
  • Ep0034 213
  • Ep0034 215
  • Ep0034 400
  • Ep0034 402
  • Ep0034 411
  • Ep0034 694
  • Ep0034 569
  • Ep0034 693
  • Ep0034 563
  • Ep0034 564
  • Ep0034 568
  • Ep0034 650
  • Ep0034 660
  • Ep0034 724
  • Ep0034 721
  • Ep0034 433
  • Ep0034 420
  • Ep0034 422
  • Ep0034 431
  • Ep0034 423
  • Ep0034 425
  • Ep0034 429
  • Ep0034 430
  • Ep0034 428
  • Ep0034 750
  • Ep0034 574
  • Ep0034 581
  • Ep0034 572
  • Ep0034 582
  • Ep0034 573
  • Ep0034 576
  • Ep0034 580
  • Ep0034 570
  • Ep0034 577
  • Ep0034 450
  • Ep0034 443
  • Ep0034 444
  • Ep0034 454
  • Ep0034 442
  • Ep0034 449
  • Ep0034 456
  • Ep0034 452
  • Ep0034 453
  • Ep0034 455
  • Ep0034 441
  • Ep0034 440
  • Ep0034 730
  • Ep0034 446
  • Ep0034 458
  • Ep0034 447
  • Ep0034 461
  • Ep0034 464
  • Ep0034 460
  • Ep0034 462
  • Ep0034 463
  • Ep0034 470
  • Ep0034 472
  • Ep0034 670
  • Ep0034 220
  • Ep0034 222
  • Ep0034 224
  • Ep0034 236
  • Ep0034 235
  • Ep0034 230
  • Ep0034 232
  • Ep0034 231
  • Ep0034 233
  • Ep0034 602
  • Ep0034 609
  • Ep0034 681
  • Ep0034 600
  • Ep0034 606
  • Ep0034 682
  • Ep0034 603
  • Ep0034 515
  • Ep0034 511

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lacosamide

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant 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 LCM in EP0034, and within 30 days of last dose.
Percentage of Participants With Serious TEAEs
A serious adverse event (SAE) must meet 1 or more of the following criteria: • Death, • Life-threatening (Life-threatening does not include a reaction that might have caused death had it occurred in a more severe form.), • Significant or persistent disability/incapacity, • Congenital anomaly/birth defect (including that occurring in a fetus), • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious., • Initial inpatient hospitalization or prolongation of hospitalization. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
Percentage of Participants With TEAEs Leading to Study Discontinuation
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant 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 LCM in EP0034, and within 30 days of last dose.

Secondary Outcome Measures

Percentage of Seizure-free Days During the Study
The number of seizure-free days was the total number of days within an interval for which daily diary data were available and no seizures were reported. The percentage of seizure-free days was computed as 100 times the number of seizure-free days in the interval divided by the number of days in the interval for which daily diary data were available. Percentage of seizure-free days was measured using data obtained from participant diaries from EP0034 and is presented for the overall Treatment only.

Full Information

First Posted
October 14, 2013
Last Updated
September 30, 2022
Sponsor
UCB BIOSCIENCES, Inc.
Collaborators
UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT01964560
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 13, 2014 (Actual)
Primary Completion Date
April 13, 2022 (Actual)
Study Completion Date
April 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB BIOSCIENCES, Inc.
Collaborators
UCB Biopharma SRL

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Lacosamide, Vimpat, UCB, Epilepsy, Partial-Onset Seizures, 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
540 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lacosamide
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
VIMPAT
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
VIMPAT
Intervention Description
Pharmaceutical form: tablet Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day) Route of administration: oral use
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant 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 LCM in EP0034, and within 30 days of last dose.
Time Frame
From Week 0 to the End of Safety Follow-Up (up to Week 104)
Title
Percentage of Participants With Serious TEAEs
Description
A serious adverse event (SAE) must meet 1 or more of the following criteria: • Death, • Life-threatening (Life-threatening does not include a reaction that might have caused death had it occurred in a more severe form.), • Significant or persistent disability/incapacity, • Congenital anomaly/birth defect (including that occurring in a fetus), • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious., • Initial inpatient hospitalization or prolongation of hospitalization. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.
Time Frame
From Week 0 to the End of Safety Follow-Up (up to Week 104)
Title
Percentage of Participants With TEAEs Leading to Study Discontinuation
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant 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 LCM in EP0034, and within 30 days of last dose.
Time Frame
From Week 0 to the End of Safety Follow-Up (up to Week 104)
Secondary Outcome Measure Information:
Title
Percentage of Seizure-free Days During the Study
Description
The number of seizure-free days was the total number of days within an interval for which daily diary data were available and no seizures were reported. The percentage of seizure-free days was computed as 100 times the number of seizure-free days in the interval divided by the number of days in the interval for which daily diary data were available. Percentage of seizure-free days was measured using data obtained from participant diaries from EP0034 and is presented for the overall Treatment only.
Time Frame
From Week 0 to End of Treatment (up to Week 96)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Ep0034 638
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-1711
Country
United States
Facility Name
Ep0034 105
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Ep0034 117
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Ep0034 124
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0284
Country
United States
Facility Name
Ep0034 115
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Ep0034 120
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Ep0034 102
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Ep0034 640
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Ep0034 129
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Ep0034 630
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Ep0034 114
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105-0371
Country
United States
Facility Name
Ep0034 143
City
Ciudad Autonoma de Buenos Aire
Country
Argentina
Facility Name
Ep0034 142
City
Cordoba
Country
Argentina
Facility Name
Ep0034 200
City
Melbourne
Country
Australia
Facility Name
Ep0034 203
City
Parkville
Country
Australia
Facility Name
Ep0034 205
City
South Brisbane
Country
Australia
Facility Name
Ep0034 304
City
Brussels
Country
Belgium
Facility Name
Ep0034 158
City
Passo Fundo
Country
Brazil
Facility Name
Ep0034 150
City
Sao Paulo
Country
Brazil
Facility Name
Ep0034 154
City
Sao Paulo
Country
Brazil
Facility Name
Ep0034 310
City
Plovdiv
Country
Bulgaria
Facility Name
Ep0034 530
City
Beijing
Country
China
Facility Name
Ep0034 535
City
Changchun
Country
China
Facility Name
Ep0034 532
City
Chongqing
Country
China
Facility Name
Ep0034 536
City
Nanchang
Country
China
Facility Name
Ep0034 531
City
Shanghai
Country
China
Facility Name
Ep0034 537
City
Shenzhen
Country
China
Facility Name
Ep0034 171
City
Medellin
Country
Colombia
Facility Name
Ep0034 613
City
Osijek
Country
Croatia
Facility Name
Ep0034 610
City
Rijeka
Country
Croatia
Facility Name
Ep0034 612
City
Zagreb
Country
Croatia
Facility Name
Ep0034 321
City
Hradec Kralove
Country
Czechia
Facility Name
Ep0034 320
City
Ostrava-poruba
Country
Czechia
Facility Name
Ep0034 322
City
Praha 4 - Krc
Country
Czechia
Facility Name
Ep0034 323
City
Praha 5
Country
Czechia
Facility Name
Ep0034 331
City
Tallinn
Country
Estonia
Facility Name
Ep0034 330
City
Tartu
Country
Estonia
Facility Name
Ep0034 346
City
Rennes Cedex 2
Country
France
Facility Name
Ep0034 344
City
Strasbourg Cedex
Country
France
Facility Name
Ep0034 620
City
Tbilisi
Country
Georgia
Facility Name
Ep0034 621
City
Tbilisi
Country
Georgia
Facility Name
Ep0034 622
City
Tbilisi
Country
Georgia
Facility Name
Ep0034 623
City
Tbilisi
Country
Georgia
Facility Name
Ep0034 542
City
Athens
Country
Greece
Facility Name
Ep0034 361
City
Budapest
Country
Hungary
Facility Name
Ep0034 362
City
Budapest
Country
Hungary
Facility Name
Ep0034 363
City
Budapest
Country
Hungary
Facility Name
Ep0034 364
City
Budapest
Country
Hungary
Facility Name
Ep0034 368
City
Budapest
Country
Hungary
Facility Name
Ep0034 360
City
Debrecen
Country
Hungary
Facility Name
Ep0034 367
City
Miskolc
Country
Hungary
Facility Name
Ep0034 366
City
Pecs
Country
Hungary
Facility Name
Ep0034 374
City
Petah Tiqwa
Country
Israel
Facility Name
Ep0034 397
City
Genova
Country
Italy
Facility Name
Ep0034 380
City
Mantova
Country
Italy
Facility Name
Ep0034 398
City
Messina
Country
Italy
Facility Name
Ep0034 381
City
Milano
Country
Italy
Facility Name
Ep0034 393
City
Padova
Country
Italy
Facility Name
Ep0034 383
City
Roma
Country
Italy
Facility Name
Ep0034 392
City
Roma
Country
Italy
Facility Name
Ep0034 395
City
Roma
Country
Italy
Facility Name
Ep0034 386
City
Verona
Country
Italy
Facility Name
Ep0034 211
City
Daegu
Country
Korea, Republic of
Facility Name
Ep0034 210
City
Seoul
Country
Korea, Republic of
Facility Name
Ep0034 212
City
Seoul
Country
Korea, Republic of
Facility Name
Ep0034 213
City
Seoul
Country
Korea, Republic of
Facility Name
Ep0034 215
City
Seoul
Country
Korea, Republic of
Facility Name
Ep0034 400
City
Riga
Country
Latvia
Facility Name
Ep0034 402
City
Valmiera
Country
Latvia
Facility Name
Ep0034 411
City
Kaunas
Country
Lithuania
Facility Name
Ep0034 694
City
Aguascalientes
Country
Mexico
Facility Name
Ep0034 569
City
Culiacan
Country
Mexico
Facility Name
Ep0034 693
City
Culiacan
Country
Mexico
Facility Name
Ep0034 563
City
Guadalajara
Country
Mexico
Facility Name
Ep0034 564
City
Mexico
Country
Mexico
Facility Name
Ep0034 568
City
Monterrey
Country
Mexico
Facility Name
Ep0034 650
City
Chisinau
Country
Moldova, Republic of
Facility Name
Ep0034 660
City
Podgorica
Country
Montenegro
Facility Name
Ep0034 724
City
Cebu
Country
Philippines
Facility Name
Ep0034 721
City
Manila
Country
Philippines
Facility Name
Ep0034 433
City
Gdansk
Country
Poland
Facility Name
Ep0034 420
City
Kielce
Country
Poland
Facility Name
Ep0034 422
City
Krakow
Country
Poland
Facility Name
Ep0034 431
City
Krakow
Country
Poland
Facility Name
Ep0034 423
City
Poznan
Country
Poland
Facility Name
Ep0034 425
City
Poznan
Country
Poland
Facility Name
Ep0034 429
City
Tyniec Maly
Country
Poland
Facility Name
Ep0034 430
City
Warszawa
Country
Poland
Facility Name
Ep0034 428
City
Wroclaw
Country
Poland
Facility Name
Ep0034 750
City
Lisbon
Country
Portugal
Facility Name
Ep0034 574
City
Bucuresti
Country
Romania
Facility Name
Ep0034 581
City
Bucuresti
Country
Romania
Facility Name
Ep0034 572
City
Cluj-napoca
Country
Romania
Facility Name
Ep0034 582
City
Iasi
Country
Romania
Facility Name
Ep0034 573
City
Sibiu
Country
Romania
Facility Name
Ep0034 576
City
Sibiu
Country
Romania
Facility Name
Ep0034 580
City
Suceava
Country
Romania
Facility Name
Ep0034 570
City
Timisoara
Country
Romania
Facility Name
Ep0034 577
City
Timisoara
Country
Romania
Facility Name
Ep0034 450
City
Ekaterinburg
Country
Russian Federation
Facility Name
Ep0034 443
City
Kazan
Country
Russian Federation
Facility Name
Ep0034 444
City
Kazan
Country
Russian Federation
Facility Name
Ep0034 454
City
Kemerovo
Country
Russian Federation
Facility Name
Ep0034 442
City
Moscow
Country
Russian Federation
Facility Name
Ep0034 449
City
Moscow
Country
Russian Federation
Facility Name
Ep0034 456
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
Ep0034 452
City
Novosibirsk
Country
Russian Federation
Facility Name
Ep0034 453
City
Omsk
Country
Russian Federation
Facility Name
Ep0034 455
City
Perm
Country
Russian Federation
Facility Name
Ep0034 441
City
Saint Petersburg
Country
Russian Federation
Facility Name
Ep0034 440
City
Smolensk
Country
Russian Federation
Facility Name
Ep0034 730
City
Smolensk
Country
Russian Federation
Facility Name
Ep0034 446
City
St. Petersburg
Country
Russian Federation
Facility Name
Ep0034 458
City
Tomsk
Country
Russian Federation
Facility Name
Ep0034 447
City
Voronezh
Country
Russian Federation
Facility Name
Ep0034 461
City
Belgrade
Country
Serbia
Facility Name
Ep0034 464
City
Belgrade
Country
Serbia
Facility Name
Ep0034 460
City
Kragujevac
Country
Serbia
Facility Name
Ep0034 462
City
Novi Sad
Country
Serbia
Facility Name
Ep0034 463
City
Novi Sad
Country
Serbia
Facility Name
Ep0034 470
City
Bardejov
Country
Slovakia
Facility Name
Ep0034 472
City
Nove Zamky
Country
Slovakia
Facility Name
Ep0034 670
City
Ljubljana
Country
Slovenia
Facility Name
Ep0034 220
City
Changhua City
Country
Taiwan
Facility Name
Ep0034 222
City
Taichung
Country
Taiwan
Facility Name
Ep0034 224
City
Taipei
Country
Taiwan
Facility Name
Ep0034 236
City
Bangkoknoi
Country
Thailand
Facility Name
Ep0034 235
City
Pathum Wan
Country
Thailand
Facility Name
Ep0034 230
City
Ratchathewi
Country
Thailand
Facility Name
Ep0034 232
City
Ratchathewi
Country
Thailand
Facility Name
Ep0034 231
City
Tha Muang
Country
Thailand
Facility Name
Ep0034 233
City
Tha Muang
Country
Thailand
Facility Name
Ep0034 602
City
Dnipro
Country
Ukraine
Facility Name
Ep0034 609
City
Dnipro
Country
Ukraine
Facility Name
Ep0034 681
City
Ivano-frankivsk
Country
Ukraine
Facility Name
Ep0034 600
City
Kiev
Country
Ukraine
Facility Name
Ep0034 606
City
Kiev
Country
Ukraine
Facility Name
Ep0034 682
City
Uzhgorod
Country
Ukraine
Facility Name
Ep0034 603
City
Vinnytsia
Country
Ukraine
Facility Name
Ep0034 515
City
Cambridge
Country
United Kingdom
Facility Name
Ep0034 511
City
Leeds
Country
United Kingdom

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
Links:
URL
https://www.ucb.com/_up/ucb_com_products/documents/Vimpat_Labeling_Oct_2021.pdf
Description
Product Information
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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