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Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older (SP0993)

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ClinicalTrials.gov Identifier: NCT01243177
Recruitment Status : Completed
First Posted : November 18, 2010
Results First Posted : February 23, 2016
Last Update Posted : July 18, 2018
Sponsor:
Collaborator:
Eden Sarl
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )

Tracking Information
First Submitted Date  ICMJE November 16, 2010
First Posted Date  ICMJE November 18, 2010
Results First Submitted Date  ICMJE January 25, 2016
Results First Posted Date  ICMJE February 23, 2016
Last Update Posted Date July 18, 2018
Study Start Date  ICMJE April 2011
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2016)
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 6 consecutive months (26 consecutive weeks) of treatment ]
    The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.
  • Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks) [ Time Frame: Duration of 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.
  • Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks) [ Time Frame: Duration of 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.
  • Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks) [ Time Frame: Duration of 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2010)
Proportion of subjects remaining seizure free for 6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject [ Time Frame: 6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject ]
Change History Complete list of historical versions of study NCT01243177 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2016)
Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject [ Time Frame: 12 consecutive months of treatment 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2010)
Proportion of subjects remaining seizure free for 12 consecutive months following stabilization at the last evaluated dose for each subject [ Time Frame: 12 consecutive months of treatment following stabilization at the last evaluated dose for each subject ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older
Official Title  ICMJE A Multicenter, Double-blind, Double-dummy, Randomized, Positive- Controlled Study Comparing the Efficacy and Safety of Lacosamide (200 to 600 mg/Day) to Controlled Release Carbamazepine (400 to 1200 mg/Day), Used as Monotherapy in Subjects (≥ 16 Years) Newly or Recently Diagnosed With Epilepsy and Experiencing Partial-onset or Generalized Tonic-clonic Seizures.
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Epilepsy
  • Monotherapy
Intervention  ICMJE
  • Drug: Lacosamide

    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
    Other Name: Vimpat®
  • Drug: Carbamazepine-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
    Other Name: Tegretol® Retard Tablets 200 mg
Study Arms  ICMJE
  • Experimental: Lacosamide
    Intervention: Drug: Lacosamide
  • Active Comparator: Carbamazepine-Controlled Release (CBZ-CR)
    Intervention: Drug: Carbamazepine-Controlled Release
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2015)
888
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2010)
878
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Bulgaria,   Canada,   Czechia,   Finland,   France,   Germany,   Greece,   Hungary,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   Switzerland,   Thailand,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01243177
Other Study ID Numbers  ICMJE SP0993
2010-019765-28 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB BIOSCIENCES GmbH )
Study Sponsor  ICMJE UCB BIOSCIENCES GmbH
Collaborators  ICMJE Eden Sarl
Investigators  ICMJE
Study Director: UCB Cares +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP