Trial Review

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/ct2/show/NCT00175903




Registration number
NCT00175903
Ethics application status
Date submitted
9/09/2005
Date registered
15/09/2005
Date last updated
17/03/2015

Titles & IDs
Public title
Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy
Scientific title
A Therapeutic Confirmatory, Open-label, Multi-center, Randomized 2 Parallel Groups, Community-based Trial Studying the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral Tablets 250-500 mg b.i.d.) Compared to Sodium Valproate (1000 to 2000 mg/Day Oral ER Tablets 300-500 mg b.i.d.) and Carbamazepine (600 to 1600 mg/Day Oral CR Tablets 200-400 mg b.i.d.) as Monotherapy in Subjects With Newly Diagnosed Epilepsy.
Secondary ID [1] 0 0
2004-001339-41
Secondary ID [2] 0 0
N01175
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Levetiracetam
Treatment: Drugs - Carbamazepine Controlled Release (CBZ-CR)
Treatment: Drugs - Valproate Extended Release

Experimental: Levetiracetam - Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.

Active Comparator: Older Antepileptic Drugs - Older AEDs consist of CBZ-CR 200 mg and 400 mg and VPA-ER 300 mg and 500 mg.


Treatment: Drugs: Levetiracetam
Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.

Treatment: Drugs: Carbamazepine Controlled Release (CBZ-CR)
Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily.

Treatment: Drugs: Valproate Extended Release
Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety
Timepoint [1] 0 0
Visit 1 to End of Study (approximately 52 weeks)
Secondary outcome [1] 0 0
The time to withdrawal comparing Levetiracetam versus the older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Timepoint [1] 0 0
Visit 1 to End of Study (approximately 52 weeks)
Secondary outcome [2] 0 0
The retention rate after 6 months comparing Levetiracetam versus the older Antiepileptic Drugs
Timepoint [2] 0 0
Visit 1 to Visit 4 (approximately 26 weeks)
Secondary outcome [3] 0 0
The retention rate after 12 months comparing Levetiracetam versus the older Antiepileptic Drugs
Timepoint [3] 0 0
Visit 1 to Visit 5 (approximately 52 weeks)
Secondary outcome [4] 0 0
The retention rate after 6 months comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Timepoint [4] 0 0
Visit 1 to Visit 4 (approximately 26 weeks)
Secondary outcome [5] 0 0
The retention rate after 12 months comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Timepoint [5] 0 0
Visit 1 to Visit 5 (approximately 52 weeks)
Secondary outcome [6] 0 0
Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs
Timepoint [6] 0 0
Visit 1 to Visit 4 (approximately 26 weeks)
Secondary outcome [7] 0 0
Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs
Timepoint [7] 0 0
Visit 1 to Visit 5 (approximately 52 weeks)
Secondary outcome [8] 0 0
Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs based on based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Timepoint [8] 0 0
Visit 1 to Visit 4 (approximately 26 weeks)
Secondary outcome [9] 0 0
Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs based on based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Timepoint [9] 0 0
Visit 1 to Visit 5 (approximately 52 weeks)
Secondary outcome [10] 0 0
Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs
Timepoint [10] 0 0
Visit 1 to End of Study (approximately 52 weeks)
Secondary outcome [11] 0 0
Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Timepoint [11] 0 0
Visit 1 to End of Study (approximately 52 weeks)

Eligibility
Key inclusion criteria
- Diagnosis of epilepsy (all types of seizures) was made during the past year

- Subjects must have had at least two unprovoked seizures in the past 2 years with at
least one during the last 6 months

- Female subjects without childbearing potential are eligible. Female subjects with
childbearing potential are eligible if they use a medically accepted contraceptive
method
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects previously allocated to a trial treatment (CBZ, VPA and LEV) used in this
trial

- Participation in another clinical trial with an investigational drug or device within
12 weeks of the selection visit (V1), or at any time during this trial

- Pregnant or lactating women

- Presence of known pseudoseizures within the last year

- Uncountable seizures (clusters) or history of convulsive status epilepticus

- Any disorder or condition that may interfere with the absorption, distribution,
metabolisation or excretion of drugs

- History of suicide attempt, current suicidal ideation, or other serious psychiatric
disorders requiring or having required hospitalization or medication within the
previous five years

- Presence of progressive cerebral disease, any other progressively degenerative
neurological disease, or any cerebral tumors

- Presence of a terminal illness or any medical condition that might interfere with the
subject's trial participation

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
Open (masking not used)
Who is / are masked / blinded?



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
1/02/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2007
Sample size
Target
Accrual to date
Final
1701
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Bedford Park
Recruitment hospital [3] 0 0
- Brisbane
Recruitment hospital [4] 0 0
- Cairns
Recruitment hospital [5] 0 0
- Camperdown
Recruitment hospital [6] 0 0
- Chatswood
Recruitment hospital [7] 0 0
- Clayton
Recruitment hospital [8] 0 0
- Maroochydore
Recruitment hospital [9] 0 0
- Parkville
Recruitment hospital [10] 0 0
- Perth
Recruitment hospital [11] 0 0
- Randwick
Recruitment hospital [12] 0 0
- West Heidelberg
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Bedford Park
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Cairns
Recruitment postcode(s) [5] 0 0
- Camperdown
Recruitment postcode(s) [6] 0 0
- Chatswood
Recruitment postcode(s) [7] 0 0
- Clayton
Recruitment postcode(s) [8] 0 0
- Maroochydore
Recruitment postcode(s) [9] 0 0
- Parkville
Recruitment postcode(s) [10] 0 0
- Perth
Recruitment postcode(s) [11] 0 0
- Randwick
Recruitment postcode(s) [12] 0 0
- West Heidelberg
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbrick
Country [3] 0 0
Austria
State/province [3] 0 0
Klagenfurt
Country [4] 0 0
Austria
State/province [4] 0 0
Linz
Country [5] 0 0
Austria
State/province [5] 0 0
Steyr
Country [6] 0 0
Austria
State/province [6] 0 0
Vienna
Country [7] 0 0
Belgium
State/province [7] 0 0
Brugge
Country [8] 0 0
Belgium
State/province [8] 0 0
Dendermonde
Country [9] 0 0
Belgium
State/province [9] 0 0
Edegem
Country [10] 0 0
Belgium
State/province [10] 0 0
Gent
Country [11] 0 0
Belgium
State/province [11] 0 0
Haine St Paul
Country [12] 0 0
Belgium
State/province [12] 0 0
Jette
Country [13] 0 0
Belgium
State/province [13] 0 0
Kortrijk
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Belgium
State/province [15] 0 0
Oostende
Country [16] 0 0
Belgium
State/province [16] 0 0
Ottignies
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Plovdiv
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Sofia
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Varna
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Litomysl
Country [21] 0 0
Czech Republic
State/province [21] 0 0
Ostrava-Poruba
Country [22] 0 0
Czech Republic
State/province [22] 0 0
Zlin
Country [23] 0 0
Denmark
State/province [23] 0 0
Aalborg
Country [24] 0 0
Denmark
State/province [24] 0 0
Copenhagen
Country [25] 0 0
Denmark
State/province [25] 0 0
Holbaek
Country [26] 0 0
Denmark
State/province [26] 0 0
Holstebro
Country [27] 0 0
Finland
State/province [27] 0 0
Hus (Helsinki)
Country [28] 0 0
Finland
State/province [28] 0 0
Kuopio
Country [29] 0 0
Finland
State/province [29] 0 0
Tampere
Country [30] 0 0
France
State/province [30] 0 0
Blaye
Country [31] 0 0
France
State/province [31] 0 0
Bordeaux
Country [32] 0 0
France
State/province [32] 0 0
Brest
Country [33] 0 0
France
State/province [33] 0 0
Carcassonne
Country [34] 0 0
France
State/province [34] 0 0
Cherbourg
Country [35] 0 0
France
State/province [35] 0 0
Colmar
Country [36] 0 0
France
State/province [36] 0 0
Creil
Country [37] 0 0
France
State/province [37] 0 0
Dijon
Country [38] 0 0
France
State/province [38] 0 0
Freyming Merlebach
Country [39] 0 0
France
State/province [39] 0 0
Grenoble Cedex 9
Country [40] 0 0
France
State/province [40] 0 0
La Seyne Sur Mer
Country [41] 0 0
France
State/province [41] 0 0
Lille
Country [42] 0 0
France
State/province [42] 0 0
Lyon
Country [43] 0 0
France
State/province [43] 0 0
Marseille
Country [44] 0 0
France
State/province [44] 0 0
Mulhouse
Country [45] 0 0
France
State/province [45] 0 0
Nancy
Country [46] 0 0
France
State/province [46] 0 0
Nimes
Country [47] 0 0
France
State/province [47] 0 0
Paris
Country [48] 0 0
France
State/province [48] 0 0
Rennes
Country [49] 0 0
France
State/province [49] 0 0
Roanne
Country [50] 0 0
France
State/province [50] 0 0
Saint Brieuc
Country [51] 0 0
France
State/province [51] 0 0
Saint Quentin
Country [52] 0 0
France
State/province [52] 0 0
Toulouse Cedex 04
Country [53] 0 0
France
State/province [53] 0 0
Valenciennes
Country [54] 0 0
France
State/province [54] 0 0
Vesoul
Country [55] 0 0
Germany
State/province [55] 0 0
Altenburg
Country [56] 0 0
Germany
State/province [56] 0 0
Arnsdorf
Country [57] 0 0
Germany
State/province [57] 0 0
Aschaffenburg
Country [58] 0 0
Germany
State/province [58] 0 0
Bamberg
Country [59] 0 0
Germany
State/province [59] 0 0
Berlin - Hohenschonhausen
Country [60] 0 0
Germany
State/province [60] 0 0
Berlin
Country [61] 0 0
Germany
State/province [61] 0 0
Bernau
Country [62] 0 0
Germany
State/province [62] 0 0
Bernburg
Country [63] 0 0
Germany
State/province [63] 0 0
Bielefeld
Country [64] 0 0
Germany
State/province [64] 0 0
Bonn
Country [65] 0 0
Germany
State/province [65] 0 0
Butzbach
Country [66] 0 0
Germany
State/province [66] 0 0
Celle
Country [67] 0 0
Germany
State/province [67] 0 0
Dillingen
Country [68] 0 0
Germany
State/province [68] 0 0
Dresden
Country [69] 0 0
Germany
State/province [69] 0 0
Dusseldorf
Country [70] 0 0
Germany
State/province [70] 0 0
Erbach
Country [71] 0 0
Germany
State/province [71] 0 0
Essen
Country [72] 0 0
Germany
State/province [72] 0 0
Giessen
Country [73] 0 0
Germany
State/province [73] 0 0
Gottingen
Country [74] 0 0
Germany
State/province [74] 0 0
Halle/Saale
Country [75] 0 0
Germany
State/province [75] 0 0
Halle
Country [76] 0 0
Germany
State/province [76] 0 0
Hamburg
Country [77] 0 0
Germany
State/province [77] 0 0
Jena
Country [78] 0 0
Germany
State/province [78] 0 0
Konigsbruck
Country [79] 0 0
Germany
State/province [79] 0 0
Leipzig
Country [80] 0 0
Germany
State/province [80] 0 0
Lengerich
Country [81] 0 0
Germany
State/province [81] 0 0
Liegau-Augustusbad
Country [82] 0 0
Germany
State/province [82] 0 0
Mittweida
Country [83] 0 0
Germany
State/province [83] 0 0
Munster
Country [84] 0 0
Germany
State/province [84] 0 0
Neukirchen-Vluyn
Country [85] 0 0
Germany
State/province [85] 0 0
Neumunster
Country [86] 0 0
Germany
State/province [86] 0 0
Oldenburg
Country [87] 0 0
Germany
State/province [87] 0 0
Potsdam
Country [88] 0 0
Germany
State/province [88] 0 0
Quickborn
Country [89] 0 0
Germany
State/province [89] 0 0
Regenburg
Country [90] 0 0
Germany
State/province [90] 0 0
Schalmstadt-Treysa
Country [91] 0 0
Germany
State/province [91] 0 0
Siegen
Country [92] 0 0
Germany
State/province [92] 0 0
Wermsdorf
Country [93] 0 0
Greece
State/province [93] 0 0
Aklion
Country [94] 0 0
Greece
State/province [94] 0 0
Alexandroupolis
Country [95] 0 0
Greece
State/province [95] 0 0
Athens
Country [96] 0 0
Greece
State/province [96] 0 0
Patras
Country [97] 0 0
Greece
State/province [97] 0 0
Thessalonikis
Country [98] 0 0
Greece
State/province [98] 0 0
Thessaloniki
Country [99] 0 0
Hungary
State/province [99] 0 0
Budapest
Country [100] 0 0
Hungary
State/province [100] 0 0
Debrecen
Country [101] 0 0
Hungary
State/province [101] 0 0
Pecs
Country [102] 0 0
Ireland
State/province [102] 0 0
Dublin 9
Country [103] 0 0
Ireland
State/province [103] 0 0
Dublin
Country [104] 0 0
Italy
State/province [104] 0 0
Ancona
Country [105] 0 0
Italy
State/province [105] 0 0
Asti
Country [106] 0 0
Italy
State/province [106] 0 0
Bari
Country [107] 0 0
Italy
State/province [107] 0 0
Busto Arsizio
Country [108] 0 0
Italy
State/province [108] 0 0
Casarano
Country [109] 0 0
Italy
State/province [109] 0 0
Catania
Country [110] 0 0
Italy
State/province [110] 0 0
Cremona
Country [111] 0 0
Italy
State/province [111] 0 0
Eboli
Country [112] 0 0
Italy
State/province [112] 0 0
Faenza
Country [113] 0 0
Italy
State/province [113] 0 0
Ferrara
Country [114] 0 0
Italy
State/province [114] 0 0
Firenze
Country [115] 0 0
Italy
State/province [115] 0 0
Foggia
Country [116] 0 0
Italy
State/province [116] 0 0
Forli
Country [117] 0 0
Italy
State/province [117] 0 0
Garbagnate
Country [118] 0 0
Italy
State/province [118] 0 0
Grosseto
Country [119] 0 0
Italy
State/province [119] 0 0
Milano
Country [120] 0 0
Italy
State/province [120] 0 0
Napoli
Country [121] 0 0
Italy
State/province [121] 0 0
Padova
Country [122] 0 0
Italy
State/province [122] 0 0
Perugia
Country [123] 0 0
Italy
State/province [123] 0 0
Pescara
Country [124] 0 0
Italy
State/province [124] 0 0
Pisa
Country [125] 0 0
Italy
State/province [125] 0 0
Potenza
Country [126] 0 0
Italy
State/province [126] 0 0
Prato
Country [127] 0 0
Italy
State/province [127] 0 0
Ragusa
Country [128] 0 0
Italy
State/province [128] 0 0
Reggio Emilia
Country [129] 0 0
Italy
State/province [129] 0 0
Roma
Country [130] 0 0
Italy
State/province [130] 0 0
Siena
Country [131] 0 0
Italy
State/province [131] 0 0
Taranto
Country [132] 0 0
Italy
State/province [132] 0 0
Torino
Country [133] 0 0
Italy
State/province [133] 0 0
Udine
Country [134] 0 0
Italy
State/province [134] 0 0
Verona
Country [135] 0 0
Italy
State/province [135] 0 0
Vimercate
Country [136] 0 0
Italy
State/province [136] 0 0
Vittoria
Country [137] 0 0
Netherlands
State/province [137] 0 0
Eindhoven
Country [138] 0 0
Netherlands
State/province [138] 0 0
Heerenvegen
Country [139] 0 0
Netherlands
State/province [139] 0 0
Leeuwarden
Country [140] 0 0
Netherlands
State/province [140] 0 0
Maastricht
Country [141] 0 0
Netherlands
State/province [141] 0 0
Nijmegen
Country [142] 0 0
Netherlands
State/province [142] 0 0
Tilburg
Country [143] 0 0
Norway
State/province [143] 0 0
Drammen
Country [144] 0 0
Norway
State/province [144] 0 0
Fredrikstad
Country [145] 0 0
Norway
State/province [145] 0 0
Lillehammer
Country [146] 0 0
Norway
State/province [146] 0 0
Molde
Country [147] 0 0
Norway
State/province [147] 0 0
Nordbyhagen
Country [148] 0 0
Norway
State/province [148] 0 0
Sandvika
Country [149] 0 0
Norway
State/province [149] 0 0
Stavanger
Country [150] 0 0
Norway
State/province [150] 0 0
Tonsberg
Country [151] 0 0
Norway
State/province [151] 0 0
Tromso
Country [152] 0 0
Norway
State/province [152] 0 0
Trondheim
Country [153] 0 0
Poland
State/province [153] 0 0
Bydgoszcz
Country [154] 0 0
Poland
State/province [154] 0 0
Czestochowa
Country [155] 0 0
Poland
State/province [155] 0 0
Gdansk
Country [156] 0 0
Poland
State/province [156] 0 0
Kielce
Country [157] 0 0
Poland
State/province [157] 0 0
Krakow
Country [158] 0 0
Poland
State/province [158] 0 0
Lodz
Country [159] 0 0
Poland
State/province [159] 0 0
Lublin
Country [160] 0 0
Poland
State/province [160] 0 0
Olstyn
Country [161] 0 0
Poland
State/province [161] 0 0
Poznan
Country [162] 0 0
Poland
State/province [162] 0 0
Warszawa
Country [163] 0 0
Poland
State/province [163] 0 0
Zgierz
Country [164] 0 0
Romania
State/province [164] 0 0
Bucuresti
Country [165] 0 0
Romania
State/province [165] 0 0
Cluj-Napoca
Country [166] 0 0
Romania
State/province [166] 0 0
Craiova
Country [167] 0 0
Russian Federation
State/province [167] 0 0
Krasnoyasrk
Country [168] 0 0
Russian Federation
State/province [168] 0 0
Moscow
Country [169] 0 0
Russian Federation
State/province [169] 0 0
St. Petersburg
Country [170] 0 0
Slovakia
State/province [170] 0 0
Bratislava
Country [171] 0 0
Slovakia
State/province [171] 0 0
Dolni Kubin
Country [172] 0 0
Slovakia
State/province [172] 0 0
Dubnica Nad Vahom
Country [173] 0 0
Slovakia
State/province [173] 0 0
Martin
Country [174] 0 0
Slovakia
State/province [174] 0 0
Zilina
Country [175] 0 0
Spain
State/province [175] 0 0
Badalona
Country [176] 0 0
Spain
State/province [176] 0 0
Barakaldo Vizcaya
Country [177] 0 0
Spain
State/province [177] 0 0
Barcelona
Country [178] 0 0
Spain
State/province [178] 0 0
Castellon
Country [179] 0 0
Spain
State/province [179] 0 0
Elda
Country [180] 0 0
Spain
State/province [180] 0 0
Girona
Country [181] 0 0
Spain
State/province [181] 0 0
Leganes (Madrid)
Country [182] 0 0
Spain
State/province [182] 0 0
Madrid
Country [183] 0 0
Spain
State/province [183] 0 0
Mostoles
Country [184] 0 0
Spain
State/province [184] 0 0
Murcia
Country [185] 0 0
Spain
State/province [185] 0 0
Santa Cruz De Tenerife
Country [186] 0 0
Spain
State/province [186] 0 0
Sevilla
Country [187] 0 0
Spain
State/province [187] 0 0
Terrassa
Country [188] 0 0
Spain
State/province [188] 0 0
Valencia
Country [189] 0 0
Spain
State/province [189] 0 0
Vigo
Country [190] 0 0
Sweden
State/province [190] 0 0
Karlstad
Country [191] 0 0
Sweden
State/province [191] 0 0
Linkoping
Country [192] 0 0
Sweden
State/province [192] 0 0
Motala
Country [193] 0 0
Sweden
State/province [193] 0 0
Stockholm
Country [194] 0 0
Sweden
State/province [194] 0 0
Varberg
Country [195] 0 0
Switzerland
State/province [195] 0 0
Bern
Country [196] 0 0
Switzerland
State/province [196] 0 0
Biel
Country [197] 0 0
Switzerland
State/province [197] 0 0
Geneve
Country [198] 0 0
Switzerland
State/province [198] 0 0
Lausanne
Country [199] 0 0
Switzerland
State/province [199] 0 0
St. Gallen
Country [200] 0 0
Switzerland
State/province [200] 0 0
Zurich
Country [201] 0 0
Turkey
State/province [201] 0 0
Adana
Country [202] 0 0
Turkey
State/province [202] 0 0
Ankara
Country [203] 0 0
Turkey
State/province [203] 0 0
Bursa
Country [204] 0 0
Turkey
State/province [204] 0 0
Istanbul
Country [205] 0 0
Turkey
State/province [205] 0 0
Izmir
Country [206] 0 0
United Kingdom
State/province [206] 0 0
Ashford
Country [207] 0 0
United Kingdom
State/province [207] 0 0
Bangor
Country [208] 0 0
United Kingdom
State/province [208] 0 0
Bristol
Country [209] 0 0
United Kingdom
State/province [209] 0 0
Cardiff
Country [210] 0 0
United Kingdom
State/province [210] 0 0
Dundee
Country [211] 0 0
United Kingdom
State/province [211] 0 0
Leeds
Country [212] 0 0
United Kingdom
State/province [212] 0 0
Liverpool
Country [213] 0 0
United Kingdom
State/province [213] 0 0
London
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Plymouth
Country [215] 0 0
United Kingdom
State/province [215] 0 0
Southampton
Country [216] 0 0
United Kingdom
State/province [216] 0 0
Stoke on Trent
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Sunderland
Country [218] 0 0
United Kingdom
State/province [218] 0 0
Swindon
Country [219] 0 0
United Kingdom
State/province [219] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB Pharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam
(LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release
(VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with
newly diagnosed epilepsy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00175903
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
Address 0 0
UCB Pharma
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/ct2/show/NCT00175903