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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01243177




Registration number
NCT01243177
Ethics application status
Date submitted
16/11/2010
Date registered
18/11/2010
Date last updated
2/02/2021

Titles & IDs
Public title
Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older
Scientific title
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.
Secondary ID [1] 0 0
2010-019765-28
Secondary ID [2] 0 0
SP0993
Universal Trial Number (UTN)
Trial acronym
SP0993
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Monotherapy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Lacosamide
Treatment: Drugs - Carbamazepine-Controlled Release

Experimental: Lacosamide -

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


Treatment: Drugs: 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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
6 consecutive months (26 consecutive weeks) of treatment
Primary outcome [3] 0 0
Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)
Timepoint [3] 0 0
Duration of the Treatment Phase (up to 113 weeks)
Primary outcome [4] 0 0
Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)
Timepoint [4] 0 0
Duration of the Treatment Phase (up to 113 weeks)
Primary outcome [5] 0 0
Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks)
Timepoint [5] 0 0
Duration of the Treatment Phase (up to 113 weeks)
Secondary outcome [1] 0 0
Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject
Timepoint [1] 0 0
12 consecutive months of treatment following stabilization at the last evaluated dose for each subject

Eligibility
Key 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
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2015
Sample size
Target
Accrual to date
Final
888
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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106 - East Gosford
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109 - Randwick
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102 - Westmead
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103 - Herston
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100 - Woodville
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101 - Fitzroy
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108 - Heidelberg
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104 - Chatswood
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105 - Clayton
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- East Gosford
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- Randwick
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- Westmead
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- Herston
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- Woodville
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- Fitzroy
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- Heidelberg
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- Chatswood
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- Clayton
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Thailand
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Bangkok
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Khon Kaen
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Ukraine
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Chernihiv
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Birmingham
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Glasgow
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Stoke-on-Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB BIOSCIENCES GmbH
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eden Sarl
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT01243177
Trial related presentations / 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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
+1 877 822 9493 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01243177