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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
551

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCB BIOSCIENCES GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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