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
VALOR
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
2 other identifiers
interventional
242
22 countries
115
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2015
Typical duration for phase_3
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedResults Posted
Study results publicly available
April 16, 2020
CompletedDecember 17, 2020
November 1, 2020
4 years
March 31, 2015
April 3, 2020
November 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
The primary efficacy variable was the time to the second primary generalized tonic clonic seizure (PGTCS) during the 24-week Treatment Period. Relative difference between groups (Lacosamide vs Placebo) was expressed as Hazard Ratio. The indicated measured values are the observed number of events of second PGTCS in the treatment period which form the basis of the statistical analysis of the time to event analysis. The hazard ratio compares 2 treatment groups for the times to a specified number of events (125) for the combined treatment groups, and so both the number of events and the times until those events pertain to the computation of the hazard ratio. A Hazard Ratio below 1 indicates time to second PGTCS was improved for LCM compared to Placebo.
During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
Secondary Outcomes (4)
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)
During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
Time to the First Primary Generalized Tonic Clonic (PGTC) Seizure During the Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)
During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
Percentage of Participants With at Least One Adverse Event (AE) as Reported Spontaneously by the Subject and/or Caregiver or Observed by the Investigator
From Visit 1 (Week -4) to End of Study Period (up to Week 36)
Plasma Concentrations of Lacosamide
During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
Study Arms (2)
Lacosamide
EXPERIMENTALLacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day are allowed. Maximal dose 400 mg/day for adult subjects and pediatric subjects \>= 50 kg. Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric subjects \< 30 kg.) Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric subjects 30 kg to \< 50 kg.)
Placebo
PLACEBO COMPARATORPlacebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day are allowed. Maximal dose 400mg/day for adult subjects and pediatric subjects \>= 50kg. Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric subjects \< 30kg.) Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric subjects 30kg to \< 50kg.)
Interventions
* Active Substance: Lacosamide * Pharmaceutical Form: Film-coated Tablet * Concentration: 50 mg * Route of Administration: Oral use
* Active Substance: Lacosamide * Pharmaceutical Form: Oral Solution * Concentration: 10 mg/ml * Route of Administration: Oral use
* Active Substance: Placebo * Pharmaceutical Form: Film-coated Tablet * Concentration: 50 mg * Route of Administration: Oral use
* Active Substance: Placebo * Pharmaceutical Form: Oral Solution * Concentration: 10 mg/ml * Route of Administration: Oral use
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB BIOSCIENCES, Inc.lead
- Pharmaceutical Research Associatescollaborator
Study Sites (115)
Sp0982 028
Alabaster, Alabama, 35007, United States
Sp0982 005
Little Rock, Arkansas, 72205, United States
Sp0982 018
Irvine, California, 92868, United States
Sp0982 008
Santa Monica, California, 90404, United States
Sp0982 031
Colorado Springs, Colorado, 80910, United States
Sp0982 035
Denver, Colorado, 80202, United States
Sp0982 036
Danbury, Connecticut, 06810, United States
Sp0982 011
Jacksonville, Florida, 32224, United States
Sp0982 013
Panama City, Florida, 32405, United States
Sp0982 002
Port Charlotte, Florida, 33952, United States
Sp0982 042
Wellington, Florida, 33470, United States
Sp0982 015
Boise, Idaho, 83702, United States
Sp0982 021
Peoria, Illinois, 61637, United States
Sp0982 045
Springfield, Illinois, 62702, United States
Sp0982 009
New Orleans, Louisiana, 70121, United States
Sp0982 007
Bethesda, Maryland, 20817, United States
Sp0982 010
Waldorf, Maryland, 20603, United States
Sp0982 025
Golden Valley, Minnesota, 55422, United States
Sp0982 029
St Louis, Missouri, 63131, United States
Sp0982 043
New York, New York, 10016, United States
Sp0982 053
Austin, Texas, 78758, United States
Sp0982 050
Greenville, Texas, 75401, United States
Sp0982 034
Houston, Texas, 77025, United States
Sp0982 047
San Antonio, Texas, 78207, United States
Sp0982 038
San Antonio, Texas, 78229, United States
Sp0982 027
Renton, Washington, 98057, United States
Sp0982 023
Madison, Wisconsin, 53715, United States
Sp0982 981
Parkville, Victoria, Australia
Sp0982 980
Chatswood, Australia
Sp0982 985
Heidelberg, Australia
Sp0982 986
Parkville, Australia
Sp0982 201
Brussels, Belgium
Sp0982 202
Ghent, Belgium
Sp0982 200
Leuven, Belgium
Sp0982 181
Curitiba, Brazil
Sp0982 180
Florianópolis, Brazil
Sp0982 186
Passo Fundo, Brazil
Sp0982 185
Porto Alegre, Brazil
Sp0982 188
Rio de Janeiro, Brazil
Sp0982 183
São Paulo, Brazil
Sp0982 184
São Paulo, Brazil
Sp0982 500
Blagoevgrad, Bulgaria
Sp0982 501
Sofia, Bulgaria
Sp0982 971
Beijing, China
Sp0982 976
Changchun, China
Sp0982 975
Chongqing, China
Sp0982 097
Fuzhou, China
Sp0982 973
Hangzhou, China
Sp0982 972
Shanghai, China
Sp0982 550
Ostrava Poruba, Czechia
Sp0982 553
Prague, Czechia
Sp0982 556
Prague, Czechia
Sp0982 552
Zlín, Czechia
Sp0982 255
Bron, France
Sp0982 252
Lille, France
Sp0982 251
Nancy, France
Sp0982 250
Rennes, France
Sp0982 305
Berlin, Germany
Sp0982 303
Erlangen, Germany
Sp0982 314
Freiburg im Breisgau, Germany
Sp0982 311
Marburg, Germany
Sp0982 302
München, Germany
Sp0982 600
Budapest, Hungary
Sp0982 603
Szeged, Hungary
Sp0982 850
Rehovot, Israel
Sp0982 851
Tel Litwinsky, Israel
Sp0982 351
Torino, Italy
Sp0982 907
Asaka, Japan
Sp0982 906
Fukuoka, Japan
Sp0982 910
Gifu, Japan
Sp0982 903
Hamamatsu, Japan
Sp0982 902
Hiroshima, Japan
Sp0982 913
Itami, Japan
Sp0982 912
Kagoshima, Japan
Sp0982 914
Kodaira, Japan
Sp0982 909
Kokubunji, Japan
Sp0982 901
Niigata, Japan
Sp0982 911
Ōmura, Japan
Sp0982 900
Sapporo, Japan
Sp0982 908
Shinjuku-Ku, Japan
Sp0982 904
Shizuoka, Japan
Sp0982 161
Guadalajara, Mexico
Sp0982 657
Częstochowa, Poland
Sp0982 655
Gdansk, Poland
Sp0982 658
Gdynia, Poland
Sp0982 652
Gliwice, Poland
Sp0982 651
Katowice, Poland
Sp0982 653
Katowice, Poland
Sp0982 654
Katowice, Poland
Sp0982 656
Tyniec Mały, Poland
Sp0982 650
Warsaw, Poland
Sp0982 659
Warsaw, Poland
Sp0982 451
Lisbon, Portugal
Sp0982 704
Iași, Romania
Sp0982 707
Iași, Romania
Sp0982 700
Timișoara, Romania
Sp0982 750
Kazan', Russia
Sp0982 758
Pyatigorsk, Russia
Sp0982 755
Saint Petersburg, Russia
Sp0982 756
Saint Petersburg, Russia
Sp0982 752
Samara, Russia
Sp0982 753
Smolensk, Russia
Sp0982 757
Yekaterinburg, Russia
Sp0982 821
Bardejov, Slovakia
Sp0982 823
Hlohovec, Slovakia
Sp0982 940
Daegu, South Korea
Sp0982 941
Seoul, South Korea
Sp0982 944
Seoul, South Korea
Sp0982 402
Barcelona, Spain
Sp0982 406
Córdoba, Spain
Sp0982 407
Madrid, Spain
Sp0982 404
Málaga, Spain
Sp0982 403
Seville, Spain
Sp0982 961
Taichung, Taiwan
Sp0982 960
Taipei, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 844 599 2273 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
March 31, 2015
First Posted
April 3, 2015
Study Start
April 1, 2015
Primary Completion
April 1, 2019
Study Completion
June 1, 2019
Last Updated
December 17, 2020
Results First Posted
April 16, 2020
Record last verified: 2020-11