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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02408549




Registration number
NCT02408549
Ethics application status
Date submitted
31/03/2015
Date registered
3/04/2015

Titles & IDs
Public title
Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures
Scientific 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
Secondary ID [1] 0 0
2012-001770-29
Secondary ID [2] 0 0
EP0012
Universal Trial Number (UTN)
Trial acronym
VALUE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Lacosamide Tablet
Treatment: Drugs - Lacosamide Oral Solution

Experimental: Lacosamide - 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


Treatment: Drugs: Lacosamide Tablet
* Active substance: Lacosamide
* Pharmaceutical form: Tablet
* Concentration: 50 mg and 100 mg
* Route of Administration: Oral administration

Treatment: Drugs: Lacosamide Oral Solution
* Active substance: Lacosamide
* Pharmaceutical form: Oral solution
* Concentration: 10 mg/ml
* Route of Administration: Oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Study Participants With Treatment-emergent Adverse Events (TEAEs) Over the Duration of the Treatment Period
Timepoint [1] 0 0
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
Primary outcome [2] 0 0
Number of Study Participants Withdrawn Due to TEAEs
Timepoint [2] 0 0
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
Primary outcome [3] 0 0
Number of Study Participants With New Appearance of Absence and/or Myoclonic Seizures During the Treatment Period
Timepoint [3] 0 0
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
Primary outcome [4] 0 0
Number of Study Participants 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)
Timepoint [4] 0 0
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Primary outcome [5] 0 0
Number of Study Participants With an Increase of Greater Than (>)25% to 50% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
Timepoint [5] 0 0
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Primary outcome [6] 0 0
Number of Study Participants 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)
Timepoint [6] 0 0
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Primary outcome [7] 0 0
Number of Study Participants 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)
Timepoint [7] 0 0
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Primary outcome [8] 0 0
Number of Study Participants 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)
Timepoint [8] 0 0
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Primary outcome [9] 0 0
Number of Study Participants 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)
Timepoint [9] 0 0
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Primary outcome [10] 0 0
Number of Study Participants 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)
Timepoint [10] 0 0
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Primary outcome [11] 0 0
Number of Study Participants 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)
Timepoint [11] 0 0
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Primary outcome [12] 0 0
Percentage of Study Participants With at Least 50% Worsening in Days With Absence Seizures
Timepoint [12] 0 0
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
Primary outcome [13] 0 0
Percentage of Study Participants With at Least 50% Worsening in Days With Myoclonic Seizures
Timepoint [13] 0 0
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
Secondary outcome [1] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hemoglobin)
Timepoint [1] 0 0
During the study (up to approximately 5 years)
Secondary outcome [2] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hematocrit)
Timepoint [2] 0 0
During the study (up to approximately 5 years)
Secondary outcome [3] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Platelets)
Timepoint [3] 0 0
During the study (up to approximately 5 years)
Secondary outcome [4] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Erythrocytes)
Timepoint [4] 0 0
During the study (up to approximately 5 years)
Secondary outcome [5] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Leukocytes)
Timepoint [5] 0 0
During the study (up to approximately 5 years)
Secondary outcome [6] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Basophils Absolute)
Timepoint [6] 0 0
During the study (up to approximately 5 years)
Secondary outcome [7] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Eosinophils Absolute)
Timepoint [7] 0 0
During the study (up to approximately 5 years)
Secondary outcome [8] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Lymphocytes Absolute)
Timepoint [8] 0 0
During the study (up to approximately 5 years)
Secondary outcome [9] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Monocytes Absolute )
Timepoint [9] 0 0
During the study (up to approximately 5 years)
Secondary outcome [10] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Neutrophils Absolute)
Timepoint [10] 0 0
During the study (up to approximately 5 years)
Secondary outcome [11] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Calcium)
Timepoint [11] 0 0
During the study (up to approximately 5 years)
Secondary outcome [12] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Sodium)
Timepoint [12] 0 0
During the study (up to approximately 5 years)
Secondary outcome [13] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Potassium)
Timepoint [13] 0 0
During the study (up to approximately 5 years)
Secondary outcome [14] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Chloride)
Timepoint [14] 0 0
During the study (up to approximately 5 years)
Secondary outcome [15] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Bicarbonate)
Timepoint [15] 0 0
During the study (up to approximately 5 years)
Secondary outcome [16] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Creatinine)
Timepoint [16] 0 0
During the study (up to approximately 5 years)
Secondary outcome [17] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Aspartate Aminotransferase)
Timepoint [17] 0 0
During the study (up to approximately 5 years)
Secondary outcome [18] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Alanine Aminotransferase)
Timepoint [18] 0 0
During the study (up to approximately 5 years)
Secondary outcome [19] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Chemistry Parameters (Total Bilirubin)
Timepoint [19] 0 0
During the study (up to approximately 5 years)
Secondary outcome [20] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Alkaline Phosphatase)
Timepoint [20] 0 0
During the study (up to approximately 5 years)
Secondary outcome [21] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Gamma Glutamyl Transferase)
Timepoint [21] 0 0
During the study (up to approximately 5 years)
Secondary outcome [22] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Glucose)
Timepoint [22] 0 0
During the study (up to approximately 5 years)
Secondary outcome [23] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Albumin)
Timepoint [23] 0 0
During the study (up to approximately 5 years)
Secondary outcome [24] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Total Protein)
Timepoint [24] 0 0
During the study (up to approximately 5 years)
Secondary outcome [25] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Phosphate)
Timepoint [25] 0 0
During the study (up to approximately 5 years)
Secondary outcome [26] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead Electrocardiogram (ECG) Parameter (QT Interval)
Timepoint [26] 0 0
During the study (up to approximately 5 years)
Secondary outcome [27] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
Timepoint [27] 0 0
During the study (up to approximately 5 years)
Secondary outcome [28] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
Timepoint [28] 0 0
During the study (up to approximately 5 years)
Secondary outcome [29] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
Timepoint [29] 0 0
During the study (up to approximately 5 years)
Secondary outcome [30] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
Timepoint [30] 0 0
During the study (up to approximately 5 years)
Secondary outcome [31] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (Heart Rate Interval)
Timepoint [31] 0 0
During the study (up to approximately 5 years)
Secondary outcome [32] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
Timepoint [32] 0 0
During the study (up to approximately 5 years)
Secondary outcome [33] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
Timepoint [33] 0 0
During the study (up to approximately 5 years)
Secondary outcome [34] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
Timepoint [34] 0 0
During the study (up to approximately 5 years)
Secondary outcome [35] 0 0
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
Timepoint [35] 0 0
During the study (up to approximately 5 years)
Secondary outcome [36] 0 0
Percent Change in Primary Generalized Tonic-clonic Seizure (PGTCS) Frequency Per 28 Days From Combined Baseline
Timepoint [36] 0 0
From Combined Baseline until end of Treatment Period (up to approximately 5 years)

Eligibility
Key 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
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/03/2023
Sample size
Target
Accrual to date
Final
239
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ep0012 980 - Chatswood
Recruitment hospital [2] 0 0
Ep0012 985 - Heidelberg
Recruitment hospital [3] 0 0
Ep0012 986 - Melbourne
Recruitment hospital [4] 0 0
Ep0012 981 - Parkville
Recruitment postcode(s) [1] 0 0
- Chatswood
Recruitment postcode(s) [2] 0 0
- Heidelberg
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
United States of America
State/province [11] 0 0
Wisconsin
Country [12] 0 0
Brazil
State/province [12] 0 0
Curitiba
Country [13] 0 0
Brazil
State/province [13] 0 0
Florianopolis
Country [14] 0 0
Brazil
State/province [14] 0 0
Passo Fundo
Country [15] 0 0
Brazil
State/province [15] 0 0
Porto Alegre
Country [16] 0 0
Brazil
State/province [16] 0 0
Rio de Janeiro
Country [17] 0 0
Brazil
State/province [17] 0 0
Sao Paulo
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Blagoevgrad
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Sofia
Country [20] 0 0
China
State/province [20] 0 0
Beijing
Country [21] 0 0
China
State/province [21] 0 0
Changchun
Country [22] 0 0
China
State/province [22] 0 0
Shanghai
Country [23] 0 0
Czechia
State/province [23] 0 0
Ostrava- Poruba
Country [24] 0 0
Czechia
State/province [24] 0 0
Prague
Country [25] 0 0
Czechia
State/province [25] 0 0
Praha 11
Country [26] 0 0
Czechia
State/province [26] 0 0
Zlin
Country [27] 0 0
France
State/province [27] 0 0
Bron Cedex
Country [28] 0 0
France
State/province [28] 0 0
Lille Cedex
Country [29] 0 0
France
State/province [29] 0 0
Nancy
Country [30] 0 0
Germany
State/province [30] 0 0
Erlangen
Country [31] 0 0
Germany
State/province [31] 0 0
Freiburg
Country [32] 0 0
Germany
State/province [32] 0 0
Marburg
Country [33] 0 0
Hungary
State/province [33] 0 0
Budapest
Country [34] 0 0
Hungary
State/province [34] 0 0
Szeged
Country [35] 0 0
Israel
State/province [35] 0 0
Rehovot
Country [36] 0 0
Israel
State/province [36] 0 0
Tel Hashomer
Country [37] 0 0
Italy
State/province [37] 0 0
Torino
Country [38] 0 0
Japan
State/province [38] 0 0
Fukuoka-shi
Country [39] 0 0
Japan
State/province [39] 0 0
Gifu
Country [40] 0 0
Japan
State/province [40] 0 0
Hamamatsu
Country [41] 0 0
Japan
State/province [41] 0 0
Hiroshima
Country [42] 0 0
Japan
State/province [42] 0 0
Kagoshima-city
Country [43] 0 0
Japan
State/province [43] 0 0
Kodaira-city
Country [44] 0 0
Japan
State/province [44] 0 0
Kokubunji-shi
Country [45] 0 0
Japan
State/province [45] 0 0
Niigata-city
Country [46] 0 0
Japan
State/province [46] 0 0
Omura-shi
Country [47] 0 0
Japan
State/province [47] 0 0
Sapporo-city
Country [48] 0 0
Japan
State/province [48] 0 0
Shinjuku-ku
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Daegu
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Seoul
Country [51] 0 0
Mexico
State/province [51] 0 0
Guadalajara
Country [52] 0 0
Poland
State/province [52] 0 0
Czestochowa
Country [53] 0 0
Poland
State/province [53] 0 0
Gdansk
Country [54] 0 0
Poland
State/province [54] 0 0
Gliwice
Country [55] 0 0
Poland
State/province [55] 0 0
Katowice
Country [56] 0 0
Poland
State/province [56] 0 0
Tyniec Maly
Country [57] 0 0
Poland
State/province [57] 0 0
Warszawa
Country [58] 0 0
Portugal
State/province [58] 0 0
Lisboa
Country [59] 0 0
Romania
State/province [59] 0 0
Iasi
Country [60] 0 0
Romania
State/province [60] 0 0
Timisoara
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Ekaterinburg
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Kazan
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Pyatigorsk
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Saint Petersburg
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Samara
Country [66] 0 0
Russian Federation
State/province [66] 0 0
St. Petersburg
Country [67] 0 0
Slovakia
State/province [67] 0 0
Bardejov
Country [68] 0 0
Slovakia
State/province [68] 0 0
Hlohovec
Country [69] 0 0
Spain
State/province [69] 0 0
Barcelona
Country [70] 0 0
Spain
State/province [70] 0 0
Cordoba
Country [71] 0 0
Spain
State/province [71] 0 0
Madrid
Country [72] 0 0
Spain
State/province [72] 0 0
Sevilla
Country [73] 0 0
Taiwan
State/province [73] 0 0
Taichung
Country [74] 0 0
Taiwan
State/province [74] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB BIOSCIENCES, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
001 844 599 2273
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.Vivli.org


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02408549