Clinical trial NCT02408523: A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications
Official title: A Double-blind, Randomized, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety 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
Collaborators: name: Pharmaceutical Research Associates
First posted: 2015-04-03
Enrollment: 242
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluating efficacy \& safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the open-label extension study after completion.


Eligibility criteria: Inclusion Criteria:

* Subject with a confirmed diagnosis at least 24 weeks prior to Visit 1 and a disease onset prior to 30 years of age, consistent with idiopathic generalized epilepsy (IGE) experiencing primary generalized tonic-clonic (PGTC) seizures (Type IIE) that are classifiable according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (ILAE, 1981)
* Subject has \>=3 PGTC seizures during the 16-week Combined Baseline (12-week Historical Baseline plus 4-week Prospective Baseline)
* If a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan has been performed, there must be no evidence of any progressive abnormality or any lesion likely to be associated with partial-onset seizures
* Subject has been maintained on a stable dose regimen of 1 to 2 non-benzodiazepine marketed antiepileptic drugs (AEDs) with no benzodiazepine AEDs OR 1 benzodiazepine marketed AED with 1 to 2 non benzodiazepine marketed AEDs for at least 28 days prior to Visit 1 with or without additional concurrent stable vagus nerve stimulation (VNS)
* Subjects are required to have had an electroencephalogram (EEG) report consistent with idiopathic generalized epilepsy (eg, generalized 3Hz epileptiform discharges and a normal EEG background) confirmed by a Central Reviewer

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 electronic case report form (eCRF).

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.

Primary outcomes:
measure: Time to the Second Primary Generalized Tonic Clonic (PGTC) Seizure During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)
timeFrame: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
Secondary outcomes:
measure: Percentage of Participants With Seizure Freedom for Primary Generalized Tonic Clonic (PGTC) Seizures During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)
timeFrame: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
measure: Time to the First Primary Generalized Tonic Clonic (PGTC) Seizure During the Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)
timeFrame: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
measure: Percentage of Participants With at Least One Adverse Event (AE) as Reported Spontaneously by the Subject and/or Caregiver or Observed by the Investigator
timeFrame: From Visit 1 (Week -4) to End of Study Period (up to Week 36)
measure: Plasma Concentrations of Lacosamide
timeFrame: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: Sp0982 028
state: Alabama
city: Little Rock
country: United States
facility: Sp0982 005
state: Arkansas
city: Irvine
country: United States
facility: Sp0982 018
state: California
city: Santa Monica
country: United States
facility: Sp0982 008
state: California
city: Colorado Springs
country: United States
facility: Sp0982 031
state: Colorado
city: Denver
country: United States
facility: Sp0982 035
state: Colorado
city: Danbury
country: United States
facility: Sp0982 036
state: Connecticut
city: Jacksonville
country: United States
facility: Sp0982 011
state: Florida
city: Panama City
country: United States
facility: Sp0982 013
state: Florida
city: Port Charlotte
country: United States
facility: Sp0982 002
state: Florida
city: Wellington
country: United States
facility: Sp0982 042
state: Florida
city: Boise
country: United States
facility: Sp0982 015
state: Idaho
city: Peoria
country: United States
facility: Sp0982 021
state: Illinois
city: Springfield
country: United States
facility: Sp0982 045
state: Illinois
city: New Orleans
country: United States
facility: Sp0982 009
state: Louisiana
city: Bethesda
country: United States
facility: Sp0982 007
state: Maryland
city: Waldorf
country: United States
facility: Sp0982 010
state: Maryland
city: Golden Valley
country: United States
facility: Sp0982 025
state: Minnesota
city: Saint Louis
country: United States
facility: Sp0982 029
state: Missouri
city: New York
country: United States
facility: Sp0982 043
state: New York
city: Austin
country: United States
facility: Sp0982 053
state: Texas
city: Greenville
country: United States
facility: Sp0982 050
state: Texas
city: Houston
country: United States
facility: Sp0982 034
state: Texas
city: San Antonio
country: United States
facility: Sp0982 047
state: Texas
city: San Antonio
country: United States
facility: Sp0982 038
state: Texas
city: Renton
country: United States
facility: Sp0982 027
state: Washington
city: Madison
country: United States
facility: Sp0982 023
state: Wisconsin
city: Parkville
country: Australia
facility: Sp0982 981
state: Victoria
city: Chatswood
country: Australia
facility: Sp0982 980
city: Heidelberg
country: Australia
facility: Sp0982 985
city: Parkville
country: Australia
facility: Sp0982 986
city: Brussels
country: Belgium
facility: Sp0982 201
city: Gent
country: Belgium
facility: Sp0982 202
city: Leuven
country: Belgium
facility: Sp0982 200
city: Curitiba
country: Brazil
facility: Sp0982 181
city: Florianópolis
country: Brazil
facility: Sp0982 180
city: Passo Fundo
country: Brazil
facility: Sp0982 186
city: Porto Alegre
country: Brazil
facility: Sp0982 185
city: Rio De Janeiro
country: Brazil
facility: Sp0982 188
city: São Paulo
country: Brazil
facility: Sp0982 183
city: São Paulo
country: Brazil
facility: Sp0982 184
city: Blagoevgrad
country: Bulgaria
facility: Sp0982 500
city: Sofia
country: Bulgaria
facility: Sp0982 501
city: Beijing
country: China
facility: Sp0982 971
city: Changchun
country: China
facility: Sp0982 976
city: Chongqing
country: China
facility: Sp0982 975
city: Fuzhou
country: China
facility: Sp0982 097
city: Hangzhou
country: China
facility: Sp0982 973
city: Shanghai
country: China
facility: Sp0982 972
city: Ostrava poruba
country: Czechia
facility: Sp0982 550
city: Praha
country: Czechia
facility: Sp0982 553
city: Praha
country: Czechia
facility: Sp0982 556
city: Zlín
country: Czechia
facility: Sp0982 552
city: Bron
country: France
facility: Sp0982 255
city: Lille Cedex
country: France
facility: Sp0982 252
city: Nancy
country: France
facility: Sp0982 251
city: Rennes Cedex 9
country: France
facility: Sp0982 250
city: Berlin
country: Germany
facility: Sp0982 305
city: Erlangen
country: Germany
facility: Sp0982 303
city: Freiburg
country: Germany
facility: Sp0982 314
city: Marburg
country: Germany
facility: Sp0982 311
city: Muenchen
country: Germany
facility: Sp0982 302
city: Budapest
country: Hungary
facility: Sp0982 600
city: Szeged
country: Hungary
facility: Sp0982 603
city: Reẖovot
country: Israel
facility: Sp0982 850
city: Tel HaShomer
country: Israel
facility: Sp0982 851
city: Torino
country: Italy
facility: Sp0982 351
city: Asaka
country: Japan
facility: Sp0982 907
city: Fukuoka-shi
country: Japan
facility: Sp0982 906
city: Gifu
country: Japan
facility: Sp0982 910
city: Hamamatsu
country: Japan
facility: Sp0982 903
city: Hiroshima
country: Japan
facility: Sp0982 902
city: Itami
country: Japan
facility: Sp0982 913
city: Kagoshima
country: Japan
facility: Sp0982 912
city: Kodaira
country: Japan
facility: Sp0982 914
city: Kokubunji
country: Japan
facility: Sp0982 909
city: Niigata
country: Japan
facility: Sp0982 901
city: Sapporo
country: Japan
facility: Sp0982 900
city: Shinjuku-Ku
country: Japan
facility: Sp0982 908
city: Shizuoka
country: Japan
facility: Sp0982 904
city: Ōmura
country: Japan
facility: Sp0982 911
city: Daegu
country: Korea, Republic of
facility: Sp0982 940
city: Seoul
country: Korea, Republic of
facility: Sp0982 941
city: Seoul
country: Korea, Republic of
facility: Sp0982 944
city: Guadalajara
country: Mexico
facility: Sp0982 161
city: Częstochowa
country: Poland
facility: Sp0982 657
city: Gdańsk
country: Poland
facility: Sp0982 655
city: Gdynia
country: Poland
facility: Sp0982 658
city: Gliwice
country: Poland
facility: Sp0982 652
city: Katowice
country: Poland
facility: Sp0982 651
city: Katowice
country: Poland
facility: Sp0982 653
city: Katowice
country: Poland
facility: Sp0982 654
city: Tyniec Mały
country: Poland
facility: Sp0982 656
city: Warszawa
country: Poland
facility: Sp0982 650
city: Warszawa
country: Poland
facility: Sp0982 659
city: Lisboa
country: Portugal
facility: Sp0982 451
city: Iaşi
country: Romania
facility: Sp0982 704
city: Iaşi
country: Romania
facility: Sp0982 707
city: Timişoara
country: Romania
facility: Sp0982 700
city: Ekaterinburg
country: Russian Federation
facility: Sp0982 757
city: Kazan
country: Russian Federation
facility: Sp0982 750
city: Pyatigorsk
country: Russian Federation
facility: Sp0982 758
city: Saint Petersburg
country: Russian Federation
facility: Sp0982 755
city: Saint Petersburg
country: Russian Federation
facility: Sp0982 756
city: Samara
country: Russian Federation
facility: Sp0982 752
city: Smolensk
country: Russian Federation
facility: Sp0982 753
city: Bardejov
country: Slovakia
facility: Sp0982 821
city: Hlohovec
country: Slovakia
facility: Sp0982 823
city: Barcelona
country: Spain
facility: Sp0982 402
city: Córdoba
country: Spain
facility: Sp0982 406
city: Madrid
country: Spain
facility: Sp0982 407
city: Málaga
country: Spain
facility: Sp0982 404
city: Sevilla
country: Spain
facility: Sp0982 403
city: Taichung
country: Taiwan
facility: Sp0982 961
city: Taipei
country: Taiwan
facility: Sp0982 960
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: