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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
Date last updated
14/12/2023

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
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.
Trial website
https://clinicaltrials.gov/study/NCT02408549
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02408549