The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01243177
Ethics application status
Date submitted
16/11/2010
Date registered
18/11/2010
Date last updated
18/07/2018

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 - The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.
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 - The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.
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) - 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.
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) - 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.
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) - 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.
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 - The proportion of subjects remaining seizure free for 12 months (52 weeks) was estimated using Kaplan-Meier methods.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
106 - East Gosford
Recruitment hospital [2] 0 0
109 - Randwick
Recruitment hospital [3] 0 0
102 - Westmead
Recruitment hospital [4] 0 0
103 - Herston
Recruitment hospital [5] 0 0
100 - Woodville
Recruitment hospital [6] 0 0
101 - Fitzroy
Recruitment hospital [7] 0 0
108 - Heidelberg
Recruitment hospital [8] 0 0
104 - Chatswood
Recruitment hospital [9] 0 0
105 - Clayton
Recruitment postcode(s) [1] 0 0
- East Gosford
Recruitment postcode(s) [2] 0 0
- Randwick
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment postcode(s) [4] 0 0
- Herston
Recruitment postcode(s) [5] 0 0
- Woodville
Recruitment postcode(s) [6] 0 0
- Fitzroy
Recruitment postcode(s) [7] 0 0
- Heidelberg
Recruitment postcode(s) [8] 0 0
- Chatswood
Recruitment postcode(s) [9] 0 0
- Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Wisconsin
Country [10] 0 0
United States of America
State/province [10] 0 0
Wyoming
Country [11] 0 0
Belgium
State/province [11] 0 0
Brugge
Country [12] 0 0
Belgium
State/province [12] 0 0
Hasselt
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Blagoevgrad
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Panagyurishte
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Pleven
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Russe
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Sofia
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Veliko Tarnovo
Country [20] 0 0
Canada
State/province [20] 0 0
Newfoundland and Labrador
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Canada
State/province [22] 0 0
Calgary
Country [23] 0 0
Canada
State/province [23] 0 0
Halifax Nova Scotia
Country [24] 0 0
Canada
State/province [24] 0 0
Hamilton
Country [25] 0 0
Canada
State/province [25] 0 0
Veilleux
Country [26] 0 0
Czechia
State/province [26] 0 0
Brno
Country [27] 0 0
Czechia
State/province [27] 0 0
Ostrava - Vitkovice
Country [28] 0 0
Czechia
State/province [28] 0 0
Prague
Country [29] 0 0
Czechia
State/province [29] 0 0
Praha 5
Country [30] 0 0
Czechia
State/province [30] 0 0
Zlin
Country [31] 0 0
Finland
State/province [31] 0 0
Helsinki
Country [32] 0 0
Finland
State/province [32] 0 0
Kuopio
Country [33] 0 0
France
State/province [33] 0 0
Nancy
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
France
State/province [35] 0 0
Strasbourg
Country [36] 0 0
France
State/province [36] 0 0
Toulouse Cedex 9
Country [37] 0 0
Germany
State/province [37] 0 0
Altenburg
Country [38] 0 0
Germany
State/province [38] 0 0
Aschaffenburg
Country [39] 0 0
Germany
State/province [39] 0 0
Bad Neustadt
Country [40] 0 0
Germany
State/province [40] 0 0
Berlin
Country [41] 0 0
Germany
State/province [41] 0 0
Göttingen
Country [42] 0 0
Germany
State/province [42] 0 0
Köln
Country [43] 0 0
Germany
State/province [43] 0 0
Leipzig
Country [44] 0 0
Germany
State/province [44] 0 0
Marburg
Country [45] 0 0
Germany
State/province [45] 0 0
Muenchen
Country [46] 0 0
Germany
State/province [46] 0 0
Münster
Country [47] 0 0
Germany
State/province [47] 0 0
Osnabruck
Country [48] 0 0
Greece
State/province [48] 0 0
Alexandroupoli
Country [49] 0 0
Greece
State/province [49] 0 0
Ioannina
Country [50] 0 0
Greece
State/province [50] 0 0
Thessalonikis
Country [51] 0 0
Greece
State/province [51] 0 0
Thessaloníki
Country [52] 0 0
Hungary
State/province [52] 0 0
Balassagyarmat
Country [53] 0 0
Hungary
State/province [53] 0 0
Budapest
Country [54] 0 0
Hungary
State/province [54] 0 0
Debrecen
Country [55] 0 0
Hungary
State/province [55] 0 0
Gyor
Country [56] 0 0
Hungary
State/province [56] 0 0
Pecs
Country [57] 0 0
Hungary
State/province [57] 0 0
Szeged
Country [58] 0 0
Hungary
State/province [58] 0 0
Szekszárd
Country [59] 0 0
Hungary
State/province [59] 0 0
Szombathely
Country [60] 0 0
Italy
State/province [60] 0 0
Bari
Country [61] 0 0
Italy
State/province [61] 0 0
Modena
Country [62] 0 0
Italy
State/province [62] 0 0
Padova
Country [63] 0 0
Italy
State/province [63] 0 0
Prato
Country [64] 0 0
Italy
State/province [64] 0 0
Roma
Country [65] 0 0
Japan
State/province [65] 0 0
Asaka-shi
Country [66] 0 0
Japan
State/province [66] 0 0
Hamamatsu-shi
Country [67] 0 0
Japan
State/province [67] 0 0
Kagoshima-shi
Country [68] 0 0
Japan
State/province [68] 0 0
Kamakura-shi
Country [69] 0 0
Japan
State/province [69] 0 0
Kawasaki-shi
Country [70] 0 0
Japan
State/province [70] 0 0
Kokubunji-shi
Country [71] 0 0
Japan
State/province [71] 0 0
Miyakonojo
Country [72] 0 0
Japan
State/province [72] 0 0
Nagoya-shi
Country [73] 0 0
Japan
State/province [73] 0 0
Nara-shi
Country [74] 0 0
Japan
State/province [74] 0 0
Okayama-shi
Country [75] 0 0
Japan
State/province [75] 0 0
Saitama-shi
Country [76] 0 0
Japan
State/province [76] 0 0
Sapporo-shi
Country [77] 0 0
Japan
State/province [77] 0 0
Sapporo
Country [78] 0 0
Japan
State/province [78] 0 0
Shizuoka-shi
Country [79] 0 0
Korea, Republic of
State/province [79] 0 0
Busan
Country [80] 0 0
Korea, Republic of
State/province [80] 0 0
Daegu
Country [81] 0 0
Korea, Republic of
State/province [81] 0 0
Dajeon
Country [82] 0 0
Korea, Republic of
State/province [82] 0 0
Seoul
Country [83] 0 0
Latvia
State/province [83] 0 0
Riga
Country [84] 0 0
Lithuania
State/province [84] 0 0
Alytus
Country [85] 0 0
Lithuania
State/province [85] 0 0
Kaunas
Country [86] 0 0
Lithuania
State/province [86] 0 0
Vilnius
Country [87] 0 0
Mexico
State/province [87] 0 0
San Luis Potosí
Country [88] 0 0
Philippines
State/province [88] 0 0
Manila
Country [89] 0 0
Philippines
State/province [89] 0 0
Pasig City
Country [90] 0 0
Philippines
State/province [90] 0 0
Quezon City
Country [91] 0 0
Poland
State/province [91] 0 0
Gdansk
Country [92] 0 0
Poland
State/province [92] 0 0
Katowice
Country [93] 0 0
Poland
State/province [93] 0 0
Lublin
Country [94] 0 0
Poland
State/province [94] 0 0
Poznan
Country [95] 0 0
Poland
State/province [95] 0 0
Szczecin
Country [96] 0 0
Poland
State/province [96] 0 0
Warsaw
Country [97] 0 0
Portugal
State/province [97] 0 0
Coimbra
Country [98] 0 0
Portugal
State/province [98] 0 0
Lisboa
Country [99] 0 0
Portugal
State/province [99] 0 0
Porto
Country [100] 0 0
Portugal
State/province [100] 0 0
Santa Maria da Feira
Country [101] 0 0
Romania
State/province [101] 0 0
Bucuresti
Country [102] 0 0
Romania
State/province [102] 0 0
Cluj-Napoca
Country [103] 0 0
Romania
State/province [103] 0 0
Craiova
Country [104] 0 0
Romania
State/province [104] 0 0
Iasi
Country [105] 0 0
Romania
State/province [105] 0 0
Sibiu
Country [106] 0 0
Romania
State/province [106] 0 0
Targu Mures
Country [107] 0 0
Russian Federation
State/province [107] 0 0
Kazan
Country [108] 0 0
Russian Federation
State/province [108] 0 0
Kirov
Country [109] 0 0
Russian Federation
State/province [109] 0 0
Moscow
Country [110] 0 0
Russian Federation
State/province [110] 0 0
Nizhny Novgorod
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Novosibirsk
Country [112] 0 0
Russian Federation
State/province [112] 0 0
Saint Petersburg
Country [113] 0 0
Russian Federation
State/province [113] 0 0
Saint-Petersburg
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Smolensk
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Yaroslavl
Country [116] 0 0
Slovakia
State/province [116] 0 0
Dolni Kubin
Country [117] 0 0
Slovakia
State/province [117] 0 0
Dubnica nad Vahom
Country [118] 0 0
Slovakia
State/province [118] 0 0
Hlohovec
Country [119] 0 0
Slovakia
State/province [119] 0 0
Krompachy
Country [120] 0 0
Slovakia
State/province [120] 0 0
Levoca
Country [121] 0 0
Slovakia
State/province [121] 0 0
Tornala
Country [122] 0 0
Slovakia
State/province [122] 0 0
Žilina
Country [123] 0 0
Spain
State/province [123] 0 0
Badalona
Country [124] 0 0
Spain
State/province [124] 0 0
Barcelona
Country [125] 0 0
Spain
State/province [125] 0 0
La Laguna
Country [126] 0 0
Spain
State/province [126] 0 0
Madrid
Country [127] 0 0
Spain
State/province [127] 0 0
Murcia (El Palmar)
Country [128] 0 0
Spain
State/province [128] 0 0
San Sebastian
Country [129] 0 0
Spain
State/province [129] 0 0
Santiago de Compostela
Country [130] 0 0
Spain
State/province [130] 0 0
Sevilla
Country [131] 0 0
Sweden
State/province [131] 0 0
Göteborg
Country [132] 0 0
Sweden
State/province [132] 0 0
Stockholm
Country [133] 0 0
Sweden
State/province [133] 0 0
Umea
Country [134] 0 0
Switzerland
State/province [134] 0 0
Aarau
Country [135] 0 0
Switzerland
State/province [135] 0 0
Biel
Country [136] 0 0
Switzerland
State/province [136] 0 0
Lugano
Country [137] 0 0
Switzerland
State/province [137] 0 0
St. Gallen
Country [138] 0 0
Thailand
State/province [138] 0 0
Bangkok
Country [139] 0 0
Thailand
State/province [139] 0 0
Khon Kaen
Country [140] 0 0
Ukraine
State/province [140] 0 0
Chernihiv
Country [141] 0 0
Ukraine
State/province [141] 0 0
Dnipropetrovsk
Country [142] 0 0
Ukraine
State/province [142] 0 0
Kharkov
Country [143] 0 0
Ukraine
State/province [143] 0 0
Luhansk
Country [144] 0 0
Ukraine
State/province [144] 0 0
Odesa
Country [145] 0 0
Ukraine
State/province [145] 0 0
Simferopol
Country [146] 0 0
Ukraine
State/province [146] 0 0
Vinnytsa
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Birmingham
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Glasgow
Country [149] 0 0
United Kingdom
State/province [149] 0 0
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/show/NCT01243177
Trial related presentations / publications
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
Other publications