Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older

June 21, 2018 updated by: UCB BIOSCIENCES GmbH

A Multicenter, Double-blind, Double-dummy, Follow up Study Evaluating the Long-term Safety of Lacosamide in Comparison With Controlled-release Carbamazepine Used as Monotherapy in Subjects With Partial-onset or Generalized Tonic-clonic Seizures ≥16 Years of Age Coming From the SP0993 Study.

Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with primary safety variables including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs, reporting of Serious AEs (SAEs).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

551

Phase

  • Phase 3

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

  • Australia
      • Chatswood, Australia
        • 104
      • Clayton, Australia
        • 105
      • East Gosford, Australia
        • 106
      • Fitzroy, Australia
        • 101
      • Heidelberg, Australia
        • 108
      • Herston, Australia
        • 103
      • Randwick, Australia
        • 109
  • Belgium
      • Brugge, Belgium
        • 127
      • Brugge, Belgium
        • 134
      • Hasselt, Belgium
        • 128
      • Leuven, Belgium
        • 126
  • Bulgaria
      • Blagoevgrad, Bulgaria
        • 805
      • Panagyurishte, Bulgaria
        • 807
      • Pleven, Bulgaria
        • 803
      • Russe, Bulgaria
        • 810
      • Sofia, Bulgaria
        • 811
      • Veliko Tarnovo, Bulgaria
        • 809
  • Canada
      • Greenfield Park, Canada
        • 152
      • Halifax Nova Scotia, Canada
        • 158
      • Hamilton, Canada
        • 156
      • St. John's, Canada
        • 153
  • Czechia
      • Brno, Czechia
        • 185
      • Ostrava - Vitkovice, Czechia
        • 190
      • Praha 5, Czechia
        • 184
      • Praha 6, Czechia
        • 189
      • Zlin, Czechia
        • 180
  • Finland
      • Helsinki, Finland
        • 205
      • Kuopio, Finland
        • 207
  • France
      • Nancy, France
        • 236
  • Germany
      • Altenburg, Germany
        • 263
      • BAD Neustadt, Germany
        • 265
      • Berlin, Germany
        • 257
      • Berlin, Germany
        • 262
      • Berlin, Germany
        • 270
      • Goettingen, Germany
        • 260
      • Leipzig, Germany
        • 269
      • Marburg, Germany
        • 256
      • Osnabrück, Germany
        • 259
  • Greece
      • Ioannina, Greece
        • 495
      • Thessalonikis, Greece
        • 490
      • Thessalonikis, Greece
        • 493
  • Hungary
      • Balassagyarmat, Hungary
        • 289
      • Budapest, Hungary
        • 283
      • Budapest, Hungary
        • 284
      • Debrecen, Hungary
        • 286
      • Gyor, Hungary
        • 282
      • Szeged, Hungary
        • 285
      • Szekszárd, Hungary
        • 290
      • Szombathely, Hungary
        • 291
  • Italy
      • Bari, Italy
        • 310
      • Modena, Italy
        • 309
      • Padova, Italy
        • 308
      • Prato, Italy
        • 314
      • Roma, Italy
        • 311
  • Japan
      • Asaka-shi, Japan
        • 831
      • Hamamatsu-shi, Japan
        • 833
      • Kagoshima-shi, Japan
        • 834
      • Kamakura-shi, Japan
        • 844
      • Miyazaki-shi, Japan
        • 843
      • Nagoya-shi, Japan
        • 835
      • Okayama-shi, Japan
        • 837
      • Saitama-shi, Japan
        • 828
      • Sapporo, Japan
        • 847
      • Shizuoka-shi, Japan
        • 832
  • Korea, Republic of
      • Busan, Korea, Republic of
        • 525
      • Daegu, Korea, Republic of
        • 521
      • Daejeon, Korea, Republic of
        • 518
      • Seoul, Korea, Republic of
        • 517
      • Seoul, Korea, Republic of
        • 519
      • Seoul, Korea, Republic of
        • 520
      • Seoul, Korea, Republic of
        • 523
      • Seoul, Korea, Republic of
        • 524
  • Latvia
      • Riga, Latvia
        • 751
  • Lithuania
      • Alytus, Lithuania
        • 727
      • Kaunas, Lithuania
        • 724
      • Vilnius, Lithuania
        • 728
  • Mexico
      • San Luis Potosi, Mexico
        • 547
  • Philippines
      • Manila, Philippines
        • 673
      • Pasig City, Philippines
        • 672
      • Quezon City, Philippines
        • 676
  • Poland
      • Gdansk, Poland
        • 336
      • Katowice, Poland
        • 340
      • Lublin, Poland
        • 342
      • Poznan, Poland
        • 341
      • Szczecin, Poland
        • 338
      • Warszawa, Poland
        • 343
  • Portugal
      • Coimbra, Portugal
        • 360
      • Lisboa, Portugal
        • 362
      • Lisboa, Portugal
        • 365
      • Porto, Portugal
        • 366
      • Santa Maria da Feira, Portugal
        • 361
  • Romania
      • Bucuresti, Romania
        • 576
      • Cluj-napoca, Romania
        • 569
      • Iasi, Romania
        • 570
      • Iasi, Romania
        • 579
      • Sibiu, Romania
        • 571
      • Sibiu, Romania
        • 577
      • Targu Mures, Romania
        • 572
  • Russian Federation
      • Kazan, Russian Federation
        • 387
      • Kazan, Russian Federation
        • 389
      • Kirov, Russian Federation
        • 396
      • Moscow, Russian Federation
        • 394
      • Moscow, Russian Federation
        • 401
      • Nizhny Novgorod, Russian Federation
        • 390
      • Novosibirsk, Russian Federation
        • 392
      • Saint-Petersburg, Russian Federation
        • 400
      • Saint-Petersburg, Russian Federation
        • 397
      • Smolensk, Russian Federation
        • 386
      • Yaroslavl, Russian Federation
        • 399
  • Slovakia
      • Dolni Kubin, Slovakia
        • 594
      • Dubnica Nad Vahom, Slovakia
        • 598
      • Hlohovec, Slovakia
        • 596
      • Krompachy, Slovakia
        • 600
      • Levoca, Slovakia
        • 595
      • Tornala, Slovakia
        • 599
      • Zilina, Slovakia
        • 601
  • Spain
      • Badalona, Spain
        • 422
      • Barcelona, Spain
        • 413
      • Girona, Spain
        • 417
      • La Laguna, Spain
        • 419
      • Madrid, Spain
        • 416
      • Madrid, Spain
        • 425
      • San Sebastián, Spain
        • 418
      • Santiago de Compostela, Spain
        • 414
      • Sevilla, Spain
        • 424
  • Sweden
      • Göteborg, Sweden
        • 440
      • Linköping, Sweden
        • 442
      • Stockholm, Sweden
        • 438
  • Switzerland
      • Aarau, Switzerland
        • 651
      • Biel, Switzerland
        • 654
      • Lugano, Switzerland
        • 653
  • Thailand
      • Bangkok, Thailand
        • 699
      • Bangkok, Thailand
        • 702
      • Khon Kaen, Thailand
        • 698
  • Ukraine
      • Chernihiv, Ukraine
        • 622
      • Kharkov, Ukraine
        • 626
      • Luhansk, Ukraine
        • 621
      • Odesa, Ukraine
        • 625
      • Simferopol, Ukraine
        • 632
  • United Kingdom
      • Glasgow, United Kingdom
        • 472
      • Stoke-on-Trent, United Kingdom
        • 471
  • United States
    • Alabama
      • Alabaster, Alabama, United States
        • 786
      • Huntsville, Alabama, United States
        • 799
    • Arkansas
      • Little Rock, Arkansas, United States
        • 777
    • Florida
      • Panama City, Florida, United States
        • 789
      • Port Charlotte, Florida, United States
        • 776
    • North Carolina
      • Raleigh, North Carolina, United States
        • 873
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 794
    • Texas
      • Mansfield, Texas, United States
        • 881
    • Wisconsin
      • Madison, Wisconsin, United States
        • 790

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject/legal representative is considered reliable and capable of adhering to the protocol
  • Subject has remained seizure free and completed the Maintenance Phase of the SP0993; or subject has experienced 1 or more seizures on the first or second target dose during the SP0993 Maintenance Phase
  • Subject is expected to benefit from participation in SP0994 in the opinion of the investigator

Exclusion Criteria:

  • Subject is receiving any investigational drugs or using any experimental devices in addition to LCM or CBZ-CR
  • Subject experienced a seizure at the third target dose during the Evaluation Phase or Maintenance Phase of the SP0993 study
  • Subject is taking benzodiazepines for a non-epilepsy indication
  • Subject meets a withdrawal criterion from the previous study SP0993
  • Subject is experiencing an ongoing SAE from the previous study SP0993
  • Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening. Or subject has a positive response (Yes) to either Question 4 or Question 5 of the C-SSRS at Screening in the "Since Last Visit" version

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: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lacosamide
50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years)
Drug: Lacosamide
50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years)
Other Names:
  • VIMPAT film-coated tablets
ACTIVE_COMPARATOR: Carbamazepine-Controlled Release (CBZ-CR)
200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years)
Drug: Carbamazepine-Controlled Release (CBZ-CR)
200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum 3.5 Years)
Other Names:
  • Tegretol® Retard Tablets 200 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years)
Time Frame: Up to 3.5 Years (Duration of the Treatment Phase)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.
Up to 3.5 Years (Duration of the Treatment Phase)
Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years)
Time Frame: Up to 3.5 Years (Duration of the Treatment Phase)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.
Up to 3.5 Years (Duration of the Treatment Phase)
Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years)
Time Frame: Up to 3.5 Years (Duration of the Treatment Phase)
A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.
Up to 3.5 Years (Duration of the Treatment Phase)

Collaborators and Investigators

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

Sponsor

UCB BIOSCIENCES GmbH

Collaborators

Eden Sarl

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.

General Publications

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

May 1, 2012

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

November 2, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (ESTIMATE)

November 6, 2011

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2018

Last Update Submitted That Met QC Criteria

June 21, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0994
  • 2010-021238-74 (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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