Clinical trial NCT02408549: Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Lacosamide
Vimpat
Epilepsy
Children
Primary Generalized Tonic Clonic seizures
Idiopathic Generalized Epilepsy
Adults
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2015-04-03
Enrollment: 239
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Study Participants With Treatment-emergent Adverse Events (TEAEs) Over the Duration of the Treatment Period
timeFrame: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
measure: Number of Study Participants Withdrawn Due to TEAEs
timeFrame: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
measure: Number of Study Participants With New Appearance of Absence and/or Myoclonic Seizures During the Treatment Period
timeFrame: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
measure: 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)
timeFrame: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
measure: 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)
timeFrame: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
measure: 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)
timeFrame: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
measure: 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)
timeFrame: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
measure: 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)
timeFrame: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
measure: 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)
timeFrame: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
measure: 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)
timeFrame: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
measure: 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)
timeFrame: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
measure: Percentage of Study Participants With at Least 50% Worsening in Days With Absence Seizures
timeFrame: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
measure: Percentage of Study Participants With at Least 50% Worsening in Days With Myoclonic Seizures
timeFrame: From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
Secondary outcomes:
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hemoglobin)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hematocrit)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Platelets)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Erythrocytes)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Leukocytes)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Basophils Absolute)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Eosinophils Absolute)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Lymphocytes Absolute)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Monocytes Absolute )
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Neutrophils Absolute)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Calcium)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Sodium)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Potassium)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Chloride)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Bicarbonate)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Creatinine)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Aspartate Aminotransferase)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Alanine Aminotransferase)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Chemistry Parameters (Total Bilirubin)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Alkaline Phosphatase)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Gamma Glutamyl Transferase)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Glucose)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Albumin)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Total Protein)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Serum Chemistry Parameters (Phosphate)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead Electrocardiogram (ECG) Parameter (QT Interval)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(F) Interval)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QTc(B) Interval)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (QRS Interval)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (Heart Rate Interval)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Pulse Rate)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Systolic Blood Pressure)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Diastolic Blood Pressure)
timeFrame: During the study (up to approximately 5 years)
measure: Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Vital Sign Measurements (Body Weight)
timeFrame: During the study (up to approximately 5 years)
measure: Percent Change in Primary Generalized Tonic-clonic Seizure (PGTCS) Frequency Per 28 Days From Combined Baseline
timeFrame: From Combined Baseline until end of Treatment Period (up to approximately 5 years)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: EP0012 5
state: Arkansas
city: Santa Monica
country: United States
facility: EP0012 8
state: California
city: Colorado Springs
country: United States
facility: Ep0012 31
state: Colorado
city: Loxahatchee Groves
country: United States
facility: Ep0012 42
state: Florida
city: Panama City
country: United States
facility: Ep0012 13
state: Florida
city: Port Charlotte
country: United States
facility: EP0012 2
state: Florida
city: Boise
country: United States
facility: Ep0012 15
state: Idaho
city: Peoria
country: United States
facility: Ep0012 21
state: Illinois
city: Golden Valley
country: United States
facility: Ep0012 25
state: Minnesota
city: New York
country: United States
facility: Ep0012 43
state: New York
city: Austin
country: United States
facility: Ep0012 53
state: Texas
city: Greenville
country: United States
facility: Ep0012 50
state: Texas
city: Houston
country: United States
facility: Ep0012 34
state: Texas
city: San Antonio
country: United States
facility: Ep0012 38
state: Texas
city: Renton
country: United States
facility: Ep0012 27
state: Washington
city: Madison
country: United States
facility: Ep0012 23
state: Wisconsin
city: Chatswood
country: Australia
facility: Ep0012 980
city: Heidelberg
country: Australia
facility: Ep0012 985
city: Melbourne
country: Australia
facility: Ep0012 986
city: Parkville
country: Australia
facility: Ep0012 981
city: Curitiba
country: Brazil
facility: Ep0012 181
city: Florianopolis
country: Brazil
facility: Ep0012 180
city: Passo Fundo
country: Brazil
facility: Ep0012 186
city: Porto Alegre
country: Brazil
facility: Ep0012 185
city: Rio de Janeiro
country: Brazil
facility: Ep0012 188
city: Sao Paulo
country: Brazil
facility: Ep0012 183
city: Blagoevgrad
country: Bulgaria
facility: Ep0012 500
city: Sofia
country: Bulgaria
facility: Ep0012 501
city: Beijing
country: China
facility: Ep0012 971
city: Changchun
country: China
facility: Ep0012 976
city: Shanghai
country: China
facility: Ep0012 972
city: Ostrava- Poruba
country: Czechia
facility: Ep0012 550
city: Prague
country: Czechia
facility: Ep0012 553
city: Praha 11
country: Czechia
facility: Ep0012 556
city: Zlin
country: Czechia
facility: Ep0012 552
city: Bron Cedex
country: France
facility: Ep0012 255
city: Lille Cedex
country: France
facility: Ep0012 252
city: Nancy
country: France
facility: Ep0012 251
city: Erlangen
country: Germany
facility: Ep0012 303
city: Freiburg
country: Germany
facility: Ep0012 314
city: Marburg
country: Germany
facility: Ep0012 311
city: Budapest
country: Hungary
facility: Ep0012 600
city: Szeged
country: Hungary
facility: Ep0012 603
city: Rehovot
country: Israel
facility: Ep0012 850
city: Tel Hashomer
country: Israel
facility: Ep0012 851
city: Torino
country: Italy
facility: Ep0012 351
city: Fukuoka-shi
country: Japan
facility: Ep0012 906
city: Gifu
country: Japan
facility: Ep0012 910
city: Hamamatsu
country: Japan
facility: Ep0012 903
city: Hiroshima
country: Japan
facility: Ep0012 902
city: Kagoshima-city
country: Japan
facility: Ep0012 912
city: Kodaira-city
country: Japan
facility: Ep0012 914
city: Kokubunji-shi
country: Japan
facility: Ep0012 909
city: Niigata-city
country: Japan
facility: Ep0012 901
city: Omura-shi
country: Japan
facility: Ep0012 911
city: Sapporo-city
country: Japan
facility: Ep0012 900
city: Shinjuku-ku
country: Japan
facility: Ep0012 908
city: Daegu
country: Korea, Republic of
facility: Ep0012 940
city: Seoul
country: Korea, Republic of
facility: Ep0012 941
city: Seoul
country: Korea, Republic of
facility: Ep0012 944
city: Guadalajara
country: Mexico
facility: Ep0012 161
city: Czestochowa
country: Poland
facility: Ep0012 657
city: Gdansk
country: Poland
facility: Ep0012 655
city: Gliwice
country: Poland
facility: Ep0012 652
city: Katowice
country: Poland
facility: Ep0012 651
city: Katowice
country: Poland
facility: Ep0012 653
city: Katowice
country: Poland
facility: Ep0012 654
city: Tyniec Maly
country: Poland
facility: Ep0012 656
city: Warszawa
country: Poland
facility: Ep0012 650
city: Warszawa
country: Poland
facility: Ep0012 659
city: Lisboa
country: Portugal
facility: Ep0012 451
city: Iasi
country: Romania
facility: Ep0012 704
city: Timisoara
country: Romania
facility: Ep0012 700
city: Ekaterinburg
country: Russian Federation
facility: Ep0012 757
city: Kazan
country: Russian Federation
facility: Ep0012 750
city: Pyatigorsk
country: Russian Federation
facility: Ep0012 758
city: Saint Petersburg
country: Russian Federation
facility: Ep0012 756
city: Samara
country: Russian Federation
facility: Ep0012 752
city: St. Petersburg
country: Russian Federation
facility: Ep0012 755
city: Bardejov
country: Slovakia
facility: Ep0012 821
city: Hlohovec
country: Slovakia
facility: Ep0012 823
city: Barcelona
country: Spain
facility: Ep0012 402
city: Cordoba
country: Spain
facility: Ep0012 406
city: Madrid
country: Spain
facility: Ep0012 407
city: Sevilla
country: Spain
facility: Ep0012 403
city: Taichung
country: Taiwan
facility: Ep0012 961
city: Taipei
country: Taiwan
facility: Ep0012 960
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: