Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures

June 20, 2018 updated by: UCB Pharma

An Open-Label, Multicenter, Multinational Study of Lacosamide as First Add-On Anti-epileptic Drug (AED) Treatment in Subjects With Partial-Onset Seizures

To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study consisted of 3 Periods: Period 1: a 1-week Screening Phase, Period 2: a 30-week Treatment Phase (consisting of a 6-week Titration Phase and a 24-week Maintenance Phase), and Period 3: a 3-week Taper/Safety Follow-Up Phase.

Study Type

Interventional

Enrollment (Actual)

461

Phase

  • Phase 4

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria
        • 503
  • Bulgaria
      • Blagoevrad, Bulgaria
        • 703
      • Pleven, Bulgaria
        • 706
      • Sofia, Bulgaria
        • 700
      • Sofia, Bulgaria
        • 702
      • Sofia, Bulgaria
        • 704
      • Sofia, Bulgaria
        • 705
      • Sofia, Bulgaria
        • 707
      • Sofia, Bulgaria
        • 708
      • Varna, Bulgaria
        • 701
  • Czechia
      • Hradec Kralove, Czechia
        • 736
      • Litomerice, Czechia
        • 735
      • Ostrava, Czechia
        • 733
      • Ostrava-Hrabuvka, Czechia
        • 732
      • Praha 11, Czechia
        • 737
      • Trutnov, Czechia
        • 734
  • Denmark
      • Aarhus, Denmark
        • 930
  • Finland
      • Helsinki, Finland
        • 400
      • Oulu, Finland
        • 402
      • Tampere, Finland
        • 401
  • France
      • Strasbourg, France
        • 610
      • Toulon, France
        • 611
  • Greece
      • Athens, Greece
        • 521
      • Thessaloniki, Greece
        • 520
  • Italy
      • Faenza, Italy
        • 552
      • Gallarate, Italy
        • 546
      • Napoli, Italy
        • 541
      • Pietra Ligure, Italy
        • 559
      • Prato, Italy
        • 557
      • Roma, Italy
        • 540
      • Roma, Italy
        • 549
      • Taranto, Italy
        • 542
      • Torino, Italy
        • 547
      • Trieste, Italy
        • 551
  • Mexico
      • Aguascalientes, Mexico
        • 180
      • Chihuahua, Mexico
        • 183
      • Chihuahua, Mexico
        • 185
      • Ciudad Juarez, Mexico
        • 184
      • Guadalajara, Mexico
        • 189
      • Mexico DF, Mexico
        • 181
      • Mexico DF, Mexico
        • 193
      • Mexico DF, Mexico
        • 195
      • Monterrey, Mexico
        • 186
      • Monterrey, Mexico
        • 187
      • Monterrey, Mexico
        • 188
      • Polanco, Mexico
        • 182
  • Romania
      • Bucarest, Romania
        • 815
      • Cluj-napoca, Romania
        • 810
      • Oradea, Romania
        • 814
      • Targu Mures, Romania
        • 813
  • Russian Federation
      • Kazan, Russian Federation
        • 830
      • Kazan, Russian Federation
        • 831
      • Moscow, Russian Federation
        • 834
      • Novosibirsk, Russian Federation
        • 833
  • Spain
      • Almeria, Spain
        • 592
      • Bajo Sevilla, Spain
        • 597
      • Barcelona, Spain
        • 590
      • Santiago de Compostela, Spain
        • 596
      • Valencia, Spain
        • 594
      • Valladolid, Spain
        • 599
    • Barcelona
      • Terrassa, Barcelona, Spain
        • 598
  • Switzerland
      • Lausanne, Switzerland
        • 892
  • Turkey
      • Adana, Turkey
        • 713
      • Ankara, Turkey
        • 714
      • Eskisehir, Turkey
        • 710
      • Istanbul, Turkey
        • 711
      • Istanbul, Turkey
        • 719
      • Izmir, Turkey
        • 717
      • Trabzon, Turkey
        • 718
  • United States
    • California
      • Irvine, California, United States
        • 103
      • Rancho Mirage, California, United States
        • 123
    • Florida
      • Clearwater, Florida, United States
        • 156
      • Destin, Florida, United States
        • 157
      • Hollywood, Florida, United States
        • 140
      • Ocala, Florida, United States
        • 161
    • Georgia
      • Atlanta, Georgia, United States
        • 108
      • Atlanta, Georgia, United States
        • 112
      • Augusta, Georgia, United States
        • 124
      • Macon, Georgia, United States
        • 115
      • Rome, Georgia, United States
        • 118
    • Illinois
      • Flossmoor, Illinois, United States
        • 128
    • Iowa
      • Des Moines, Iowa, United States
        • 130
    • Kentucky
      • Bowling Green, Kentucky, United States
        • 102
      • Paducah, Kentucky, United States
        • 117
    • Louisiana
      • Houma, Louisiana, United States
        • 107
      • Ruston, Louisiana, United States
        • 145
    • Maryland
      • Annapolis, Maryland, United States
        • 101
      • Waldorf, Maryland, United States
        • 162
    • Massachusetts
      • Boston, Massachusetts, United States
        • 153
      • Pittsfield, Massachusetts, United States
        • 136
      • Springfield, Massachusetts, United States
        • 144
    • Missouri
      • Kansas City, Missouri, United States
        • 151
    • New Jersey
      • Paterson, New Jersey, United States
        • 114
    • New York
      • Brooklyn, New York, United States
        • 109
      • Brooklyn, New York, United States
        • 133
      • West Seneca, New York, United States
        • 127
    • North Carolina
      • Charlotte, North Carolina, United States
        • 158
    • North Dakota
      • Bismarck, North Dakota, United States
        • 139
    • Ohio
      • Akron, Ohio, United States
        • 134
      • Canton, Ohio, United States
        • 150
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • 141
    • Pennsylvania
      • Indiana, Pennsylvania, United States
        • 121
    • South Carolina
      • Columbia, South Carolina, United States
        • 120
      • Orangeburg, South Carolina, United States
        • 149
      • Spartanburg, South Carolina, United States
        • 152
    • Texas
      • Austin, Texas, United States
        • 148
      • Dallas, Texas, United States
        • 154
      • Tomball, Texas, United States
        • 146
    • Virginia
      • Fredericksburg, Virginia, United States
        • 119

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Group 1:

  • Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
  • Currently taking adequate monotherapy (defined as a single Antiepileptic Drug (AED) for at least 28 days prior to Screening) and has no history of AED polytherapy. Prior use of rescue medication (short-term intermittent use) is acceptable
  • Epilepsy diagnosis should be ≤24 months at the time of the Screening Visit
  • The minimum allowed seizure frequency at any time during the 12 weeks prior to the Screening Visit is ≥3 partial-onset seizures

Group 2:

  • Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
  • Currently taking 1 to 3 AEDs, and has tried at least 2 prior AED treatment regimens (concurrently or sequentially)
  • Epilepsy diagnosis should be ≥5 years at the time of the Screening Visit
  • The minimum allowed seizure frequency during the 12 weeks prior to the Screening Visit is ≥1 partial-onset seizure per 28 days

Exclusion Criteria:

  • Previous use of Lacosamide
  • History of seizure disorder characterized primarily by isolated auras
  • History of primary generalized seizures
  • History of status epilepticus within last 12-months
  • History of cluster seizures during the 12 week period prior to Visit 1
  • Nonepileptic events, including pseudoseizures that could be confused with seizure
  • Lifetime history of suicide attempt or suicidal ideation in the past 6 months
  • Hypersensitivity to any component of Lacosamide
  • History of drug or alcohol abuse
  • History of an acute or subacutely progressive Central Nervous System (CNS) disease
  • Undergone cranial surgery within the last year prior to study entry
  • Concomitant treatment of Felbamate or previous Felbamate therapy within the last 6 months
  • Prior or concomitant Vigabatrin use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: First Add-on
Lacosamide added to first adequate monotherapy (no history of Antiepileptic Drug [AED] polytherapy) and epilepsy diagnosis < or = 24 months at Screening.
Drug: Lacosamide

Oral Lacosamide:

Subjects Titration Phase (6 Weeks):

Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks):

200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks):

50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week

Other Names:
  • Harkoseride
  • Vimpat
  • SPM927
EXPERIMENTAL: Later Add-on
Lacosamide added to 1 to 3 Antiepileptic Drugs (AEDs) (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.
Drug: Lacosamide

Oral Lacosamide:

Subjects Titration Phase (6 Weeks):

Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks):

200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks):

50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week

Other Names:
  • Harkoseride
  • Vimpat
  • SPM927

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Proportion of Subjects Who Achieved "Seizure-free Status" During the First 12 Weeks of the Maintenance Phase
Time Frame: From Week 7 (end of Week 6) to end of Week 18

A subject will be considered seizure-free if the subject completes the first 12 weeks of the Maintenance Phase, reports zero seizures, and has no seizure data missing for any day during the period of time.

This study was intended to assess the efficacy outcomes in the First Add-On Group and the Later Add-On Group individually relative to historical data. Comparisons between the 2 groups should not be attempted and conclusions should not be drawn.
From Week 7 (end of Week 6) to end of Week 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

August 6, 2009

First Submitted That Met QC Criteria

August 7, 2009

First Posted (ESTIMATE)

August 10, 2009

Study Record Updates

Last Update Posted (ACTUAL)

July 17, 2018

Last Update Submitted That Met QC Criteria

June 20, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0954
  • 2009-011181-28 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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