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Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures (VALUE)

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lacosamide Tablet
Lacosamide Oral Solution
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, Epilepsy, Children, Primary Generalized Tonic Clonic seizures, Idiopathic Generalized Epilepsy, Adults

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Subject must have completed or be an eligible Baseline failure from the parent study (SP0982 [NCT02408523]). Note: Other subjects screened for SP0982 may be considered for roll-over to EP0012 if the investigator considers that the subject could benefit from treatment with open-label lacosamide (LCM) and based on prior discussion with and approval from the UCB Study Physician or representative

Exclusion Criteria:

  • Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
  • Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE)
  • Subject has an active suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
  • Subject has >=2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%). For all subjects who entered EP0012 directly with a Baseline result >ULN for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the electronic Case Report form (eCRF). Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated once for confirmation.

Sites / Locations

  • EP0012 5
  • EP0012 8
  • Ep0012 31
  • Ep0012 42
  • Ep0012 13
  • EP0012 2
  • Ep0012 15
  • Ep0012 21
  • Ep0012 25
  • Ep0012 43
  • Ep0012 53
  • Ep0012 50
  • Ep0012 34
  • Ep0012 38
  • Ep0012 27
  • Ep0012 23
  • Ep0012 980
  • Ep0012 985
  • Ep0012 986
  • Ep0012 981
  • Ep0012 181
  • Ep0012 180
  • Ep0012 186
  • Ep0012 185
  • Ep0012 188
  • Ep0012 183
  • Ep0012 500
  • Ep0012 501
  • Ep0012 971
  • Ep0012 976
  • Ep0012 972
  • Ep0012 550
  • Ep0012 553
  • Ep0012 556
  • Ep0012 552
  • Ep0012 255
  • Ep0012 252
  • Ep0012 251
  • Ep0012 303
  • Ep0012 314
  • Ep0012 311
  • Ep0012 600
  • Ep0012 603
  • Ep0012 850
  • Ep0012 851
  • Ep0012 351
  • Ep0012 906
  • Ep0012 910
  • Ep0012 903
  • Ep0012 902
  • Ep0012 912
  • Ep0012 914
  • Ep0012 909
  • Ep0012 901
  • Ep0012 911
  • Ep0012 900
  • Ep0012 908
  • Ep0012 940
  • Ep0012 941
  • Ep0012 944
  • Ep0012 161
  • Ep0012 657
  • Ep0012 655
  • Ep0012 652
  • Ep0012 651
  • Ep0012 653
  • Ep0012 654
  • Ep0012 656
  • Ep0012 650
  • Ep0012 659
  • Ep0012 451
  • Ep0012 704
  • Ep0012 700
  • Ep0012 757
  • Ep0012 750
  • Ep0012 758
  • Ep0012 756
  • Ep0012 752
  • Ep0012 755
  • Ep0012 821
  • Ep0012 823
  • Ep0012 402
  • Ep0012 406
  • Ep0012 407
  • Ep0012 403
  • Ep0012 961
  • Ep0012 960

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lacosamide

Arm Description

Start dose SP0982 completers at V1: LCM 10 mg/kg/day for pediatric subjects weighing <30 kg LCM 8 mg/kg/day for pediatric subjects weighing ≥ 30kg to <50 kg LCM 400 mg/day (200 mg bid) for adult subjects (≥18 years of age) or pediatric subjects weighing ≥50 kg SP0982 Baseline failures at V1: LCM 2 mg/kg/day for pediatric subjects weighing <50 kg LCM 100 mg/day (50 mg bid) for adult subjects (≥18 years of age) or pediatric subjects weighing ≥50 kg Oral solution (pediatric subjects <50 kg): Minimum LCM dose: 4 mg/kg/day Maximum LCM dose: 12 mg/kg/day Tablets (pediatric subjects ≥50kg): Minimum LCM dose: 200 mg/day Minimum LCM dose: 600 mg/day Tablets (adult subjects): Minimum LCM dose: 200 mg/day Maximum LCM dose: 800 mg/day

Outcomes

Primary Outcome Measures

Number of subjects with treatment-emergent adverse events (TEAEs) over the duration of the Treatment Period
Adverse Events will be reported spontaneously by the subject and/or caregiver or observed by the investigator.
Number of subjects withdrawn due to TEAEs
Adverse Events will be reported spontaneously by the subject and/or caregiver or observed by the investigator.
Number of subjects with new appearance of absence and/or myoclonic seizures during the Treatment Period
Incidence of new seizure types in the EP0012 Treatment Period for all subjects who haven't had that seizure type in combined baseline or history before taking lacosamide (LCM).
Number of subjects with an increase of up to 25% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982)
Number of subjects with an increase of >25% to 50% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982)
Number of subjects with an increase of >50% to 75% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982)
Number of subjects with an increase of >75% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982)
Number of subjects with an increase of up to 25% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982)
Number of subjects with an increase of >25% to 50% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982)
Number of subjects with an increase of >50% to 75% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982)
Number of subjects with an increase of >75% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982)
Percentage of subjects with at least 50% worsening in days with absence seizures
Percentage of subjects with at least 50% worsening in days with myoclonic seizures

Secondary Outcome Measures

Percentage of treatment-emergent marked abnormalities in hematology parameters
Percentage of treatment-emergent marked abnormalities in chemistry parameters
Percentage of treatment-emergent marked abnormalities in 12-lead electrocardiogram (ECGs)
Percentage of treatment-emergent marked abnormalities in vital sign measurements
Percent change in Primary Generalized Tonic-clonic seizure (PGTCS) frequency per 28 days from Combined Baseline
Percent change in PGTCS frequency per 28 days from Combined Baseline, where Combined Baseline is defined as the combined 12-week Historical Baseline and 4-week Prospective Baseline Periods immediately prior to randomization in the parent study (SP0982).

Full Information

First Posted
March 31, 2015
Last Updated
April 28, 2023
Sponsor
UCB BIOSCIENCES, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02408549
Brief Title
Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures
Acronym
VALUE
Official Title
An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 3, 2015 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures (PGTCS) in subjects >= 4 years of age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM SP0982 [NCT02408523] study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Lacosamide, Vimpat, Epilepsy, Children, Primary Generalized Tonic Clonic seizures, Idiopathic Generalized Epilepsy, Adults

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lacosamide
Arm Type
Experimental
Arm Description
Start dose SP0982 completers at V1: LCM 10 mg/kg/day for pediatric subjects weighing <30 kg LCM 8 mg/kg/day for pediatric subjects weighing ≥ 30kg to <50 kg LCM 400 mg/day (200 mg bid) for adult subjects (≥18 years of age) or pediatric subjects weighing ≥50 kg SP0982 Baseline failures at V1: LCM 2 mg/kg/day for pediatric subjects weighing <50 kg LCM 100 mg/day (50 mg bid) for adult subjects (≥18 years of age) or pediatric subjects weighing ≥50 kg Oral solution (pediatric subjects <50 kg): Minimum LCM dose: 4 mg/kg/day Maximum LCM dose: 12 mg/kg/day Tablets (pediatric subjects ≥50kg): Minimum LCM dose: 200 mg/day Minimum LCM dose: 600 mg/day Tablets (adult subjects): Minimum LCM dose: 200 mg/day Maximum LCM dose: 800 mg/day
Intervention Type
Drug
Intervention Name(s)
Lacosamide Tablet
Other Intervention Name(s)
Vimpat, LCM
Intervention Description
Active substance: Lacosamide Pharmaceutical form: Tablet Concentration: 50 mg and 100 mg Route of Administration: Oral administration
Intervention Type
Drug
Intervention Name(s)
Lacosamide Oral Solution
Other Intervention Name(s)
Vimpat, LCM
Intervention Description
Active substance: Lacosamide Pharmaceutical form: Oral solution Concentration: 10 mg/ml Route of Administration: Oral administration
Primary Outcome Measure Information:
Title
Number of subjects with treatment-emergent adverse events (TEAEs) over the duration of the Treatment Period
Description
Adverse Events will be reported spontaneously by the subject and/or caregiver or observed by the investigator.
Time Frame
During the Treatment Period (up to 5 years)
Title
Number of subjects withdrawn due to TEAEs
Description
Adverse Events will be reported spontaneously by the subject and/or caregiver or observed by the investigator.
Time Frame
During the Treatment Period (up to 5 years)
Title
Number of subjects with new appearance of absence and/or myoclonic seizures during the Treatment Period
Description
Incidence of new seizure types in the EP0012 Treatment Period for all subjects who haven't had that seizure type in combined baseline or history before taking lacosamide (LCM).
Time Frame
During the Treatment Period (up to 5 years)
Title
Number of subjects with an increase of up to 25% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982)
Time Frame
From Visit 1 to End of Treatment Period (up to 5 years)
Title
Number of subjects with an increase of >25% to 50% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982)
Time Frame
From Visit 1 to End of Treatment Period (up to 5 years)
Title
Number of subjects with an increase of >50% to 75% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982)
Time Frame
From Visit 1 to End of Treatment Period (up to 5 years)
Title
Number of subjects with an increase of >75% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982)
Time Frame
From Visit 1 to End of Treatment Period (up to 5 years)
Title
Number of subjects with an increase of up to 25% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982)
Time Frame
From Visit 1 to End of Treatment Period (up to 5 years)
Title
Number of subjects with an increase of >25% to 50% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982)
Time Frame
From Visit 1 to End of Treatment Period (up to 5 years)
Title
Number of subjects with an increase of >50% to 75% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982)
Time Frame
From Visit 1 to End of Treatment Period (up to 5 years)
Title
Number of subjects with an increase of >75% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982)
Time Frame
From Visit 1 to End of Treatment Period (up to 5 years)
Title
Percentage of subjects with at least 50% worsening in days with absence seizures
Time Frame
From Visit 1 to End of Treatment Period (up to 5 years)
Title
Percentage of subjects with at least 50% worsening in days with myoclonic seizures
Time Frame
From Visit 1 to End of Treatment Period (up to 5 years)
Secondary Outcome Measure Information:
Title
Percentage of treatment-emergent marked abnormalities in hematology parameters
Time Frame
During the study (up to 5 years)
Title
Percentage of treatment-emergent marked abnormalities in chemistry parameters
Time Frame
During the study (up to 5 years)
Title
Percentage of treatment-emergent marked abnormalities in 12-lead electrocardiogram (ECGs)
Time Frame
During the study (up to 5 years)
Title
Percentage of treatment-emergent marked abnormalities in vital sign measurements
Time Frame
During the study (up to 5 years)
Title
Percent change in Primary Generalized Tonic-clonic seizure (PGTCS) frequency per 28 days from Combined Baseline
Description
Percent change in PGTCS frequency per 28 days from Combined Baseline, where Combined Baseline is defined as the combined 12-week Historical Baseline and 4-week Prospective Baseline Periods immediately prior to randomization in the parent study (SP0982).
Time Frame
From Combined Baseline until Termination Visit (up to 5 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Subject must have completed or be an eligible Baseline failure from the parent study (SP0982 [NCT02408523]). Note: Other subjects screened for SP0982 may be considered for roll-over to EP0012 if the investigator considers that the subject could benefit from treatment with open-label lacosamide (LCM) and based on prior discussion with and approval from the UCB Study Physician or representative Exclusion Criteria: Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM) Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE) Subject has an active suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia-Suicide Severity Rating Scale (C-SSRS) Subject has >=2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%). For all subjects who entered EP0012 directly with a Baseline result >ULN for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the electronic Case Report form (eCRF). Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated once for confirmation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273
Official's Role
Study Director
Facility Information:
Facility Name
EP0012 5
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
EP0012 8
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Ep0012 31
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Ep0012 42
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Ep0012 13
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
EP0012 2
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Ep0012 15
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Ep0012 21
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Ep0012 25
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Ep0012 43
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Ep0012 53
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Ep0012 50
City
Greenville
State/Province
Texas
ZIP/Postal Code
75401
Country
United States
Facility Name
Ep0012 34
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Ep0012 38
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Ep0012 27
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Ep0012 23
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
Ep0012 980
City
Chatswood
Country
Australia
Facility Name
Ep0012 985
City
Heidelberg
Country
Australia
Facility Name
Ep0012 986
City
Melbourne
Country
Australia
Facility Name
Ep0012 981
City
Parkville
Country
Australia
Facility Name
Ep0012 181
City
Curitiba
Country
Brazil
Facility Name
Ep0012 180
City
Florianopolis
Country
Brazil
Facility Name
Ep0012 186
City
Passo Fundo
Country
Brazil
Facility Name
Ep0012 185
City
Porto Alegre
Country
Brazil
Facility Name
Ep0012 188
City
Rio de Janeiro
Country
Brazil
Facility Name
Ep0012 183
City
Sao Paulo
Country
Brazil
Facility Name
Ep0012 500
City
Blagoevgrad
Country
Bulgaria
Facility Name
Ep0012 501
City
Sofia
Country
Bulgaria
Facility Name
Ep0012 971
City
Beijing
Country
China
Facility Name
Ep0012 976
City
Changchun
Country
China
Facility Name
Ep0012 972
City
Shanghai
Country
China
Facility Name
Ep0012 550
City
Ostrava- Poruba
Country
Czechia
Facility Name
Ep0012 553
City
Prague
Country
Czechia
Facility Name
Ep0012 556
City
Praha 11
Country
Czechia
Facility Name
Ep0012 552
City
Zlin
Country
Czechia
Facility Name
Ep0012 255
City
Bron Cedex
Country
France
Facility Name
Ep0012 252
City
Lille Cedex
Country
France
Facility Name
Ep0012 251
City
Nancy
Country
France
Facility Name
Ep0012 303
City
Erlangen
Country
Germany
Facility Name
Ep0012 314
City
Freiburg
Country
Germany
Facility Name
Ep0012 311
City
Marburg
Country
Germany
Facility Name
Ep0012 600
City
Budapest
Country
Hungary
Facility Name
Ep0012 603
City
Szeged
Country
Hungary
Facility Name
Ep0012 850
City
Rehovot
Country
Israel
Facility Name
Ep0012 851
City
Tel Hashomer
Country
Israel
Facility Name
Ep0012 351
City
Torino
Country
Italy
Facility Name
Ep0012 906
City
Fukuoka-shi
Country
Japan
Facility Name
Ep0012 910
City
Gifu
Country
Japan
Facility Name
Ep0012 903
City
Hamamatsu
Country
Japan
Facility Name
Ep0012 902
City
Hiroshima
Country
Japan
Facility Name
Ep0012 912
City
Kagoshima-city
Country
Japan
Facility Name
Ep0012 914
City
Kodaira-city
Country
Japan
Facility Name
Ep0012 909
City
Kokubunji-shi
Country
Japan
Facility Name
Ep0012 901
City
Niigata-city
Country
Japan
Facility Name
Ep0012 911
City
Omura-shi
Country
Japan
Facility Name
Ep0012 900
City
Sapporo-city
Country
Japan
Facility Name
Ep0012 908
City
Shinjuku-ku
Country
Japan
Facility Name
Ep0012 940
City
Daegu
Country
Korea, Republic of
Facility Name
Ep0012 941
City
Seoul
Country
Korea, Republic of
Facility Name
Ep0012 944
City
Seoul
Country
Korea, Republic of
Facility Name
Ep0012 161
City
Guadalajara
Country
Mexico
Facility Name
Ep0012 657
City
Czestochowa
Country
Poland
Facility Name
Ep0012 655
City
Gdansk
Country
Poland
Facility Name
Ep0012 652
City
Gliwice
Country
Poland
Facility Name
Ep0012 651
City
Katowice
Country
Poland
Facility Name
Ep0012 653
City
Katowice
Country
Poland
Facility Name
Ep0012 654
City
Katowice
Country
Poland
Facility Name
Ep0012 656
City
Tyniec Maly
Country
Poland
Facility Name
Ep0012 650
City
Warszawa
Country
Poland
Facility Name
Ep0012 659
City
Warszawa
Country
Poland
Facility Name
Ep0012 451
City
Lisboa
Country
Portugal
Facility Name
Ep0012 704
City
Iasi
Country
Romania
Facility Name
Ep0012 700
City
Timisoara
Country
Romania
Facility Name
Ep0012 757
City
Ekaterinburg
Country
Russian Federation
Facility Name
Ep0012 750
City
Kazan
Country
Russian Federation
Facility Name
Ep0012 758
City
Pyatigorsk
Country
Russian Federation
Facility Name
Ep0012 756
City
Saint Petersburg
Country
Russian Federation
Facility Name
Ep0012 752
City
Samara
Country
Russian Federation
Facility Name
Ep0012 755
City
St. Petersburg
Country
Russian Federation
Facility Name
Ep0012 821
City
Bardejov
Country
Slovakia
Facility Name
Ep0012 823
City
Hlohovec
Country
Slovakia
Facility Name
Ep0012 402
City
Barcelona
Country
Spain
Facility Name
Ep0012 406
City
Cordoba
Country
Spain
Facility Name
Ep0012 407
City
Madrid
Country
Spain
Facility Name
Ep0012 403
City
Sevilla
Country
Spain
Facility Name
Ep0012 961
City
Taichung
Country
Taiwan
Facility Name
Ep0012 960
City
Taipei
Country
Taiwan

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

Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures

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