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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02408549
Ethics application status
Date submitted
31/03/2015
Date registered
3/04/2015
Date last updated
24/06/2019

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 - Lasosamide Oral Solution

Experimental: Lacosamide - Start dose
SP982 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
SP982 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: Lasosamide 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 subjects experiencing at least one Adverse Event (AE) during the study (up to 5 years) - Adverse Events will be reported spontaneously by the subject and/or caregiver or observed by the investigator.
Timepoint [1] 0 0
During the study (up to 5 years)
Primary outcome [2] 0 0
Number of subjects withdrawing due to Adverse Events (AEs) during the study (up to 5 years) - Adverse Events will be reported spontaneously by the subject and/or caregiver or observed by the investigator.
Timepoint [2] 0 0
During the study (up to 5 years)
Primary outcome [3] 0 0
Incidence of new seizure types during the Treatment Period
Timepoint [3] 0 0
During the Treatment Period (up to 5 years)
Primary outcome [4] 0 0
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)
Timepoint [4] 0 0
From Visit 1 to End of Treatment Period (up to 5 years)
Primary outcome [5] 0 0
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)
Timepoint [5] 0 0
From Visit 1 to End of Treatment Period (up to 5 years)
Primary outcome [6] 0 0
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)
Timepoint [6] 0 0
From Visit 1 to End of Treatment Period (up to 5 years)
Primary outcome [7] 0 0
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)
Timepoint [7] 0 0
From Visit 1 to End of Treatment Period (up to 5 years)
Primary outcome [8] 0 0
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)
Timepoint [8] 0 0
From Visit 1 to End of Treatment Period (up to 5 years)
Primary outcome [9] 0 0
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)
Timepoint [9] 0 0
From Visit 1 to End of Treatment Period (up to 5 years)
Primary outcome [10] 0 0
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)
Timepoint [10] 0 0
From Visit 1 to End of Treatment Period (up to 5 years)
Primary outcome [11] 0 0
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)
Timepoint [11] 0 0
From Visit 1 to End of Treatment Period (up to 5 years)
Secondary outcome [1] 0 0
Percent change in Primary Generalized Tonic-clonic (PGTC) seizure frequency per 28 days from Combined Baseline - Percent change in PGTC seizure 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).
Timepoint [1] 0 0
From Combined Baseline until Termination Visit (up to 5 years)
Secondary outcome [2] 0 0
Percentage of treatment-emergent marked abnormalities in hematology parameters
Timepoint [2] 0 0
During the study (up to 5 years)
Secondary outcome [3] 0 0
Percentage of treatment-emergent marked abnormalities in chemistry parameters
Timepoint [3] 0 0
During the study (up to 5 years)
Secondary outcome [4] 0 0
Percentage of treatment-emergent marked abnormalities in 12-lead electrocardiogram (ECGs)
Timepoint [4] 0 0
During the study (up to 5 years)
Secondary outcome [5] 0 0
Percentage of treatment-emergent marked abnormalities in vital sign measurements
Timepoint [5] 0 0
During the study (up to 5 years)

Eligibility
Key inclusion criteria
-Subject must have completed or be an eligible Baseline failure from the parent study
(SP0982). 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
Gender
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 randomized subjects 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 Case Report form (CRF).

If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at screening,
repeat the tests, if possible, prior to dosing to ensure there is no further ongoing
clinically relevant increase. In case of a clinically relevant increase, inclusion of the
subject must be discussed with the Medical Monitor. Tests that result in ALT, AST, or ALP
up to 25% above the exclusion limit may be repeated once for confirmation. This includes
re-screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 981 - Parkville
Recruitment hospital [4] 0 0
Ep0012 986 - Parkville
Recruitment postcode(s) [1] 0 0
- Chatswood
Recruitment postcode(s) [2] 0 0
- Heidelberg
Recruitment postcode(s) [3] 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
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
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Idaho
Country [8] 0 0
United States of America
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Illinois
Country [9] 0 0
United States of America
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Louisiana
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Minnesota
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Missouri
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Nebraska
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New York
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Texas
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Virginia
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Washington
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United States of America
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Wisconsin
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Brazil
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Curitiba
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Brazil
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Florianopolis
Country [20] 0 0
Brazil
State/province [20] 0 0
Passo Fundo
Country [21] 0 0
Brazil
State/province [21] 0 0
Porto Alegre
Country [22] 0 0
Brazil
State/province [22] 0 0
Rio de Janeiro
Country [23] 0 0
Brazil
State/province [23] 0 0
Sao Paulo
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Blagoevgrad
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Sofia
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China
State/province [26] 0 0
Beijing
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China
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Changchun
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China
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Chongqing
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China
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Fujian
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China
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Hanzhou
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China
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Nanchang
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China
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Shanghai
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China
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Wenzhou
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Czechia
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Ostarva Poruba
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Czechia
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Praha 11
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Czechia
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Praha
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Zlin
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Nancy
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Erlangen
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Freiburg
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Leipzig
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Marburg
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Ulm
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Budapest
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Debrecen
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Szeged
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Re?ovot
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Czestochowa
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Gdynia
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Gliwice
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Katowice
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Tyniec Maly
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Warszawa
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Portugal
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Lisboa
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Iasi
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Romania
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Timisoara
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Russian Federation
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Ekaterinburg
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Kazan
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Pyatigorsk
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Samara
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Sankt Petersburg
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Russian Federation
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Smolensk
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Slovakia
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Bardejov
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Slovakia
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Hlohovec
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Spain
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Aravaca
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Barcelona
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Cordoba
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Madrid
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Malaga
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Spain
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Sevilla
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Taiwan
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Taichung
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Taiwan
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Taipei

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

Ethics approval
Ethics application status

Summary
Brief summary
Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy
for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects >= 4 years of
age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM
SP0982 (NCT02408523) study.
Trial website
https://clinicaltrials.gov/show/NCT02408549
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
+18445992273 (UCB)
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

Summary results
Other publications