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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

NCT ID: NCT02408523

Last Updated: 2020-12-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Epilepsy

Keywords

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Lacosamide Vimpat Epilepsy Children Primary Generalized Tonic Clonic seizures Idiopathic Generalized Epilepsy Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lacosamide

Lacosamide 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.)

Group Type EXPERIMENTAL

Lacosamide Tablet

Intervention Type DRUG

* Active Substance: Lacosamide
* Pharmaceutical Form: Film-coated Tablet
* Concentration: 50 mg
* Route of Administration: Oral use

Lasosamide Oral Solution

Intervention Type DRUG

* Active Substance: Lacosamide
* Pharmaceutical Form: Oral Solution
* Concentration: 10 mg/ml
* Route of Administration: Oral use

Placebo

Placebo 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.)

Group Type PLACEBO_COMPARATOR

Placebo Tablet

Intervention Type OTHER

* Active Substance: Placebo
* Pharmaceutical Form: Film-coated Tablet
* Concentration: 50 mg
* Route of Administration: Oral use

Placebo Oral Solution

Intervention Type OTHER

* Active Substance: Placebo
* Pharmaceutical Form: Oral Solution
* Concentration: 10 mg/ml
* Route of Administration: Oral use

Interventions

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Lacosamide Tablet

* Active Substance: Lacosamide
* Pharmaceutical Form: Film-coated Tablet
* Concentration: 50 mg
* Route of Administration: Oral use

Intervention Type DRUG

Lasosamide Oral Solution

* Active Substance: Lacosamide
* Pharmaceutical Form: Oral Solution
* Concentration: 10 mg/ml
* Route of Administration: Oral use

Intervention Type DRUG

Placebo Tablet

* Active Substance: Placebo
* Pharmaceutical Form: Film-coated Tablet
* Concentration: 50 mg
* Route of Administration: Oral use

Intervention Type OTHER

Placebo Oral Solution

* Active Substance: Placebo
* Pharmaceutical Form: Oral Solution
* Concentration: 10 mg/ml
* Route of Administration: Oral use

Intervention Type OTHER

Other Intervention Names

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Vimpat Vimpat

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmaceutical Research Associates

OTHER

Sponsor Role collaborator

UCB BIOSCIENCES, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Cares

Role: STUDY_DIRECTOR

+1 844 599 2273 (UCB)

Locations

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Sp0982 028

Alabaster, Alabama, United States

Site Status

Sp0982 005

Little Rock, Arkansas, United States

Site Status

Sp0982 018

Irvine, California, United States

Site Status

Sp0982 008

Santa Monica, California, United States

Site Status

Sp0982 031

Colorado Springs, Colorado, United States

Site Status

Sp0982 035

Denver, Colorado, United States

Site Status

Sp0982 036

Danbury, Connecticut, United States

Site Status

Sp0982 011

Jacksonville, Florida, United States

Site Status

Sp0982 013

Panama City, Florida, United States

Site Status

Sp0982 002

Port Charlotte, Florida, United States

Site Status

Sp0982 042

Wellington, Florida, United States

Site Status

Sp0982 015

Boise, Idaho, United States

Site Status

Sp0982 021

Peoria, Illinois, United States

Site Status

Sp0982 045

Springfield, Illinois, United States

Site Status

Sp0982 009

New Orleans, Louisiana, United States

Site Status

Sp0982 007

Bethesda, Maryland, United States

Site Status

Sp0982 010

Waldorf, Maryland, United States

Site Status

Sp0982 025

Golden Valley, Minnesota, United States

Site Status

Sp0982 029

St Louis, Missouri, United States

Site Status

Sp0982 043

New York, New York, United States

Site Status

Sp0982 053

Austin, Texas, United States

Site Status

Sp0982 050

Greenville, Texas, United States

Site Status

Sp0982 034

Houston, Texas, United States

Site Status

Sp0982 047

San Antonio, Texas, United States

Site Status

Sp0982 038

San Antonio, Texas, United States

Site Status

Sp0982 027

Renton, Washington, United States

Site Status

Sp0982 023

Madison, Wisconsin, United States

Site Status

Sp0982 981

Parkville, Victoria, Australia

Site Status

Sp0982 980

Chatswood, , Australia

Site Status

Sp0982 985

Heidelberg, , Australia

Site Status

Sp0982 986

Parkville, , Australia

Site Status

Sp0982 201

Brussels, , Belgium

Site Status

Sp0982 202

Ghent, , Belgium

Site Status

Sp0982 200

Leuven, , Belgium

Site Status

Sp0982 181

Curitiba, , Brazil

Site Status

Sp0982 180

Florianópolis, , Brazil

Site Status

Sp0982 186

Passo Fundo, , Brazil

Site Status

Sp0982 185

Porto Alegre, , Brazil

Site Status

Sp0982 188

Rio de Janeiro, , Brazil

Site Status

Sp0982 183

São Paulo, , Brazil

Site Status

Sp0982 184

São Paulo, , Brazil

Site Status

Sp0982 500

Blagoevgrad, , Bulgaria

Site Status

Sp0982 501

Sofia, , Bulgaria

Site Status

Sp0982 971

Beijing, , China

Site Status

Sp0982 976

Changchun, , China

Site Status

Sp0982 975

Chongqing, , China

Site Status

Sp0982 097

Fuzhou, , China

Site Status

Sp0982 973

Hangzhou, , China

Site Status

Sp0982 972

Shanghai, , China

Site Status

Sp0982 550

Ostrava Poruba, , Czechia

Site Status

Sp0982 553

Prague, , Czechia

Site Status

Sp0982 556

Prague, , Czechia

Site Status

Sp0982 552

Zlín, , Czechia

Site Status

Sp0982 255

Bron, , France

Site Status

Sp0982 252

Lille, , France

Site Status

Sp0982 251

Nancy, , France

Site Status

Sp0982 250

Rennes, , France

Site Status

Sp0982 305

Berlin, , Germany

Site Status

Sp0982 303

Erlangen, , Germany

Site Status

Sp0982 314

Freiburg im Breisgau, , Germany

Site Status

Sp0982 311

Marburg, , Germany

Site Status

Sp0982 302

München, , Germany

Site Status

Sp0982 600

Budapest, , Hungary

Site Status

Sp0982 603

Szeged, , Hungary

Site Status

Sp0982 850

Rehovot, , Israel

Site Status

Sp0982 851

Tel Litwinsky, , Israel

Site Status

Sp0982 351

Torino, , Italy

Site Status

Sp0982 907

Asaka, , Japan

Site Status

Sp0982 906

Fukuoka, , Japan

Site Status

Sp0982 910

Gifu, , Japan

Site Status

Sp0982 903

Hamamatsu, , Japan

Site Status

Sp0982 902

Hiroshima, , Japan

Site Status

Sp0982 913

Itami, , Japan

Site Status

Sp0982 912

Kagoshima, , Japan

Site Status

Sp0982 914

Kodaira, , Japan

Site Status

Sp0982 909

Kokubunji, , Japan

Site Status

Sp0982 901

Niigata, , Japan

Site Status

Sp0982 911

Ōmura, , Japan

Site Status

Sp0982 900

Sapporo, , Japan

Site Status

Sp0982 908

Shinjuku-Ku, , Japan

Site Status

Sp0982 904

Shizuoka, , Japan

Site Status

Sp0982 161

Guadalajara, , Mexico

Site Status

Sp0982 657

Częstochowa, , Poland

Site Status

Sp0982 655

Gdansk, , Poland

Site Status

Sp0982 658

Gdynia, , Poland

Site Status

Sp0982 652

Gliwice, , Poland

Site Status

Sp0982 651

Katowice, , Poland

Site Status

Sp0982 653

Katowice, , Poland

Site Status

Sp0982 654

Katowice, , Poland

Site Status

Sp0982 656

Tyniec Mały, , Poland

Site Status

Sp0982 650

Warsaw, , Poland

Site Status

Sp0982 659

Warsaw, , Poland

Site Status

Sp0982 451

Lisbon, , Portugal

Site Status

Sp0982 704

Iași, , Romania

Site Status

Sp0982 707

Iași, , Romania

Site Status

Sp0982 700

Timișoara, , Romania

Site Status

Sp0982 750

Kazan', , Russia

Site Status

Sp0982 758

Pyatigorsk, , Russia

Site Status

Sp0982 755

Saint Petersburg, , Russia

Site Status

Sp0982 756

Saint Petersburg, , Russia

Site Status

Sp0982 752

Samara, , Russia

Site Status

Sp0982 753

Smolensk, , Russia

Site Status

Sp0982 757

Yekaterinburg, , Russia

Site Status

Sp0982 821

Bardejov, , Slovakia

Site Status

Sp0982 823

Hlohovec, , Slovakia

Site Status

Sp0982 940

Daegu, , South Korea

Site Status

Sp0982 941

Seoul, , South Korea

Site Status

Sp0982 944

Seoul, , South Korea

Site Status

Sp0982 402

Barcelona, , Spain

Site Status

Sp0982 406

Córdoba, , Spain

Site Status

Sp0982 407

Madrid, , Spain

Site Status

Sp0982 404

Málaga, , Spain

Site Status

Sp0982 403

Seville, , Spain

Site Status

Sp0982 961

Taichung, , Taiwan

Site Status

Sp0982 960

Taipei, , Taiwan

Site Status

Countries

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Turkey (Türkiye) United States Australia Belgium Brazil Bulgaria China Czechia France Germany Hungary Israel Italy Japan Mexico Poland Portugal Romania Russia Slovakia South Korea Spain Taiwan

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

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http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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2011-003100-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP0982

Identifier Type: -

Identifier Source: org_study_id