CClinicalTrials.gg
Sign In
CompletedNCT01243177SP0993Updated Feb 2, 2021Results posted

Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older

A Phase 3 interventional study of Lacosamide and Carbamazepine-Controlled Release in Epilepsy and Monotherapy, sponsored by UCB BIOSCIENCES GmbH. Completed at 184 sites in 29 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2021-02-02.

Sponsored by UCB BIOSCIENCES GmbH · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
888
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study summary

Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit balance between Lacosamide (LCM) and Carbamazepine-CR (CBZ-CR).

02

Conditions studied

  • Epilepsy
  • Monotherapy

Browse trials for

Keywords

  • Lacosamide
  • Vimpat®
  • Epilepsy
  • Monotherapy
  • Velocity
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 888 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

UCB BIOSCIENCES GmbH is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subject able to comply with study requirements
  • Subject is 16 years and older (female; male). Minors will be included in countries only if legally permitted
  • Subject has newly or recently diagnosed Epilepsy experiencing partial onset seizures (POS) or generalized tonic-clonic seizures with at least 2 unprovoked seizures separated by 48 hours in the 12 months preceding Visit 1 out of which at least 1 seizure occured 3 months preceding Visit 1
  • Subject has had an Electroencephalogram (EEG) and a brain Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) exam of the brain within the past 12 months. If the EEG and brain CT scan or MRI exam were not performed prior to Visit 1, they need to be completed and results must be available prior to randomization at Visit 2

Exclusion criteria

Exclusion Criteria:

  • Subject has a history or presence of seizures of other types than partial-onset (IA, IB, IC with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures (eg, myoclonic, absence)
  • Subject has a history or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time (ie, \< 20 minutes) with or without function regained between 2 ictal events
  • Subject has a history, clinical, or Electroencephalogram (EEG) finding suggestive of Idiopathic Generalized Epilepsy (IGE) at randomization
  • Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events that could be confused with seizures based on expert opinion and/or EEG evidence
  • Subject has any medical or psychiatric condition
  • Subject has a lifetime history of suicide attempt (including an actual 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
  • Subject has received treatment with Phenobarbital or Primidone within 28 days prior to Visit 1
  • Subject is taking Benzodiazepines for a nonepilepsy indication
  • Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) (including Benzodiazepines) in the last 6 months before Visit. However, acute and subacute seizure treatment is accepted with a maximum of 2 weeks duration and if treatment was stopped at least 3 days prior to randomization
  • Prior use of Felbamate or Vigabatrin is not allowed
  • Benzodiazepines as rescue therapy for Epilepsy may have been used as needed in this time period, but not more frequently than once per week
  • Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion, has a history of alcohol or drug abuse within the previous 2 years
  • Asian ancestry and tests positive for HLA-B*1502 allele
  • Asian ancestry and tests positive for HLA-A*3101 allele
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
888 participants (actual)

Study arms

  • Experimental
    Lacosamide

    Drug: Lacosamide

  • Active comparator
    Carbamazepine-Controlled Release (CBZ-CR)

    Drug: Carbamazepine-Controlled Release

Interventions

  • DrugLacosamide

    Lacosamide: * Strengths: 50 mg / 100 mg * Form: tablets * Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose * Duration: up to 118 weeks

    Also known as: Vimpat®

  • DrugCarbamazepine-Controlled Release

    Carbamazepine-CR: * Strengths: 200 mg * Form: tablets * Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose * Duration: up to 118 weeks

    Also known as: Tegretol® Retard Tablets 200 mg

06

What researchers measure

Primary outcomes

  1. Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject

    The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.

    Time frame: 6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject

  2. Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject

    The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.

    Time frame: 6 consecutive months (26 consecutive weeks) of treatment

  3. Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)

    An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.

    Time frame: Duration of the Treatment Phase (up to 113 weeks)

  4. Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)

    An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.

    Time frame: Duration of the Treatment Phase (up to 113 weeks)

  5. Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks)

    An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A Serious Adverse Event must meet 1 or more predefined criteria like death, life-threatening, etc. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.

    Time frame: Duration of the Treatment Phase (up to 113 weeks)

Secondary outcomes

  1. Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject

    The proportion of subjects remaining seizure free for 12 months (52 weeks) was estimated using Kaplan-Meier methods.

    Time frame: 12 consecutive months of treatment following stabilization at the last evaluated dose for each subject

07

Results

Posted Feb 23, 2016

Participant flow

This study started to enroll in April 2011 and concluded in August 2015.

Participant flow — Overall Study
MilestoneLacosamideCarbamazepine-Controlled Release (CBZ-CR)
Started444442
Completed266264
Not completed178178
Withdrew: Lack of efficacy4731
Withdrew: Protocol violation1110
Withdrew: Lost to follow-up1518
Withdrew: Withdrawal by subject4638
Withdrew: Ae, serious fatal01
Withdrew: Sae, non-fatal79
Withdrew: Ae, non-serious non-fatal4058
Withdrew: Sae, fatal + sae, non-fatal10
Withdrew: Sae,non-fatal+ae,non-serious non-fatal01
Withdrew: Other reason1112

Outcome measures

PrimaryProportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject

The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.

Time frame:
6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject
Reported as:
Number · percentage of subjects
Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject
percentage of subjectsLacosamideCarbamazepine-Controlled Release (CBZ-CR)
Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject89.8 (86.8 to 92.8)91.1 (88.2 to 94.0)
Statistical analysis
  • Lacosamide vs Carbamazepine-Controlled Release (CBZ-CR) · Mantel Haenszel · Mean difference (final values): -1.3 · 95% CI -5.5 to 2.8The lower limit of the confidence interval was \>-12 %, noninferiority of LCM to CBZ-CR was demonstrated. Additionally, the lower confidence limit relative to the CBZ-CR seizure freedom rate was \>- 20 %.
PrimaryProportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject

The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.

Time frame:
6 consecutive months (26 consecutive weeks) of treatment
Reported as:
Number · percentage of subjects
Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject
percentage of subjectsLacosamideCarbamazepine-Controlled Release (CBZ-CR)
Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject91.4 (88.5 to 94.3)92.8 (90.1 to 95.6)
Statistical analysis
  • Lacosamide vs Carbamazepine-Controlled Release (CBZ-CR) · Mantel Haenszel · Mean difference (final values): -1.3 · 95% CI -5.3 to 2.7The lower limit of the confidence interval was \>-12 %, noninferiority of LCM to CBZ-CR was demonstrated. Additionally, the lower confidence limit relative to the CBZ-CR seizure freedom rate was \>- 20 %.
PrimaryNumber of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)

An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.

Time frame:
Duration of the Treatment Phase (up to 113 weeks)
Reported as:
Number · Participants
Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)
ParticipantsLacosamideCarbamazepine-Controlled Release (CBZ-CR)
Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)328332
PrimaryNumber of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)

An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.

Time frame:
Duration of the Treatment Phase (up to 113 weeks)
Reported as:
Number · Participants
Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)
ParticipantsLacosamideCarbamazepine-Controlled Release (CBZ-CR)
Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)4769
SecondaryProportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject

The proportion of subjects remaining seizure free for 12 months (52 weeks) was estimated using Kaplan-Meier methods.

Time frame:
12 consecutive months of treatment following stabilization at the last evaluated dose for each subject
Reported as:
Number · percentage of subjects
Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject
percentage of subjectsLacosamideCarbamazepine-Controlled Release (CBZ-CR)
Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject77.8 (73.4 to 82.2)82.7 (78.5 to 86.8)
PrimaryNumber of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks)

An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A Serious Adverse Event must meet 1 or more predefined criteria like death, life-threatening, etc. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.

Time frame:
Duration of the Treatment Phase (up to 113 weeks)
Reported as:
Number · Participants
Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks)
ParticipantsLacosamideCarbamazepine-Controlled Release (CBZ-CR)
Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks)3243

Adverse events

Collected over Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lacosamide—36/444 (8.1%)165/444 (37.2%)
Carbamazepine-Controlled Release (CBZ-CR)—46/442 (10.4%)181/442 (41%)
Most frequent serious events
Showing 10 of 90
Most frequent serious events
EventLacosamideCarbamazepine-Controlled Release (CBZ-CR)
ConvulsionNervous system disorders4/4442/442
Partial seizures with secondary generalisationNervous system disorders0/4443/442
Cerebrovascular accidentNervous system disorders0/4442/442
Grand mal convulsionNervous system disorders0/4442/442
Ischaemic strokeNervous system disorders0/4442/442
Drug reaction with eosinophilia and systemic symptomsSkin and subcutaneous tissue disorders0/4442/442
Gait disturbanceGeneral disorders2/4440/442
Tendon ruptureInjury, poisoning and procedural complications2/4440/442
Complex partial seizuresNervous system disorders2/4441/442
EpilepsyNervous system disorders2/4440/442
Most frequent other events
Most frequent other events
EventLacosamideCarbamazepine-Controlled Release (CBZ-CR)
HeadacheNervous system disorders60/44458/442
DizzinessNervous system disorders53/44441/442
FatigueGeneral disorders34/44449/442
SomnolenceNervous system disorders27/44441/442
Gamma-glutamyltransferase increasedInvestigations7/44435/442
NasopharyngitisInfections and infestations29/44429/442
NauseaGastrointestinal disorders26/44423/442

Baseline characteristics

Baseline Characteristics refer to the Safety Analysis Set which is defined as all randomized subjects who took at least 1 dose of study medication and is identical with the Full Analysis Set.

Age, Categorical
Age, Categorical(Participants)LacosamideCarbamazepine-Controlled Release (CBZ-CR)Total Title
<=18 years271946
Between 18 and 65 years355366721
>=65 years6257119
Age, Continuous
Age, Continuous(years)LacosamideCarbamazepine-Controlled Release (CBZ-CR)Total Title
Mean41.9 ± 17.941.8 ± 17.241.8 ± 17.6
Sex: Female, Male
Sex: Female, Male(Participants)LacosamideCarbamazepine-Controlled Release (CBZ-CR)Total Title
Female201210411
Male243232475
08

Study locations

184 sites
  • 786
    Alabaster, Alabama, United States
  • 799
    Huntsville, Alabama, United States
  • 780
    Phoenix, Arizona, United States
  • 777
    Little Rock, Arkansas, United States
  • 795
    Ocala, Florida, United States
  • 789
    Panama City, Florida, United States
  • 776
    Port Charlotte, Florida, United States
  • 779
    Manhattan, Kansas, United States
  • 874
    Charlotte, North Carolina, United States
  • 876
    Hickory, North Carolina, United States
  • 873
    Raleigh, North Carolina, United States
  • 794
    Oklahoma City, Oklahoma, United States
  • 881
    Mansfield, Texas, United States
  • 790
    Madison, Wisconsin, United States
  • 798
    Casper, Wyoming, United States
  • 106
    East Gosford, New South Wales, Australia
  • 109
    Randwick, New South Wales, Australia
  • 102
    Westmead, New South Wales, Australia
  • 103
    Herston, Queensland, Australia
  • 100
    Woodville, South Australia, Australia
  • 101
    Fitzroy, Victoria, Australia
  • 108
    Heidelberg, Victoria, Australia
  • 104
    Chatswood, Australia
  • 105
    Clayton, Australia
  • 127
    Brugge, Belgium
  • 134
    Brugge, Belgium
  • 128
    Hasselt, Belgium
  • 126
    Leuven, Belgium
  • 805
    Blagoevgrad, Bulgaria
  • 807
    Panagyurishte, Bulgaria
  • 803
    Pleven, Bulgaria
  • 810
    Russe, Bulgaria
  • 806
    Sofia, Bulgaria
  • 808
    Sofia, Bulgaria
  • 811
    Sofia, Bulgaria
  • 809
    Veliko Tarnovo, Bulgaria
  • 153
    St John's, Newfoundland and Labrador, Canada
  • 152
    Greenfield Park, Quebec, Canada
  • 155
    Calgary, Canada
  • 158
    Halifax Nova Scotia, Canada
  • 156
    Hamilton, Canada
  • 159
    Veilleux, Canada
  • 185
    Brno, Czechia
  • 190
    Ostrava - Vitkovice, Czechia
  • 189
    Prague, Czechia
  • 184
    Praha 5, Czechia
  • 180
    Zlin, Czechia
  • 205
    Helsinki, Finland
  • 207
    Kuopio, Finland
  • 236
    Nancy, France
  • 233
    Paris, France
  • 231
    Strasbourg, France
  • 235
    Toulouse Cedex 9, France
  • 263
    Altenburg, Germany
  • 258
    Aschaffenburg, Germany
  • 265
    Bad Neustadt, Germany
  • 257
    Berlin, Germany
  • 262
    Berlin, Germany
  • 270
    Berlin, Germany
  • 260
    Göttingen, Germany
  • 271
    Köln, Germany
  • 269
    Leipzig, Germany
  • 256
    Marburg, Germany
  • 264
    Muenchen, Germany
  • 261
    Münster, Germany
  • 259
    Osnabruck, Germany
  • 496
    Alexandroupoli, Greece
  • 495
    Ioannina, Greece
  • 490
    Thessalonikis, Greece
  • 493
    Thessaloníki, Greece
  • 289
    Balassagyarmat, Hungary
  • 283
    Budapest, Hungary
  • 284
    Budapest, Hungary
  • 286
    Debrecen, Hungary
  • 282
    Gyor, Hungary
  • 288
    Pecs, Hungary
  • 285
    Szeged, Hungary
  • 290
    Szekszárd, Hungary
  • 291
    Szombathely, Hungary
  • 310
    Bari, Italy
  • 309
    Modena, Italy
  • 308
    Padova, Italy
  • 314
    Prato, Italy
  • 311
    Roma, Italy
  • 831
    Asaka-shi, Japan
  • 833
    Hamamatsu-shi, Japan
  • 834
    Kagoshima-shi, Japan
  • 844
    Kamakura-shi, Japan
  • 846
    Kawasaki-shi, Japan
  • 829
    Kokubunji-shi, Japan
  • 843
    Miyakonojo, Japan
  • 835
    Nagoya-shi, Japan
  • 830
    Nara-shi, Japan
  • 837
    Okayama-shi, Japan
  • 828
    Saitama-shi, Japan
  • 836
    Sapporo-shi, Japan
  • 847
    Sapporo, Japan
  • 832
    Shizuoka-shi, Japan
  • 525
    Busan, Korea, Republic of
  • 521
    Daegu, Korea, Republic of

Showing the first 100 of 184 sites across 29 countries.

09

References and documents

Publications

  • Baulac M, Rosenow F, Toledo M, Terada K, Li T, De Backer M, Werhahn KJ, Brock M. Efficacy, safety, and tolerability of lacosamide monotherapy versus controlled-release carbamazepine in patients with newly diagnosed epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurol. 2017 Jan;16(1):43-54. doi: 10.1016/S1474-4422(16)30292-7. Epub 2016 Nov 24. Erratum In: Lancet Neurol. 2017 Feb;16(2):102. doi: 10.1016/S1474-4422(16)30403-3. PubMed 27889312 ↗
  • Mintzer S, Dimova S, Zhang Y, Steiniger-Brach B, De Backer M, Chellun D, Roebling R. Effects of lacosamide and carbamazepine on lipids in a randomized trial. Epilepsia. 2020 Dec;61(12):2696-2704. doi: 10.1111/epi.16745. Epub 2020 Nov 17. PubMed 33200428 ↗
  • Lindauer A, Laveille C, Stockis A. Time-to-Seizure Modeling of Lacosamide Used in Monotherapy in Patients with Newly Diagnosed Epilepsy. Clin Pharmacokinet. 2017 Nov;56(11):1403-1413. doi: 10.1007/s40262-017-0530-8. PubMed 28290119 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01243177
Lead sponsor
UCB BIOSCIENCES GmbH
Collaborators
Eden Sarl
Responsible party
Sponsor
First posted
Nov 18, 2010
Start date
Apr 2011
Primary completion
Jul 2015
Completion
Aug 2015
Results posted
Feb 23, 2016
Last update
Feb 2, 2021

Study contacts

UCB Cares
study director · +1 877 822 9493 (UCB)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Epilepsy→

Other studies from this sponsor

UCB BIOSCIENCES GmbH

Start the discussion