Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00515619




Registration number
NCT00515619
Ethics application status
Date submitted
13/08/2007
Date registered
14/08/2007
Date last updated
28/08/2017

Titles & IDs
Public title
Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures
Scientific title
An International Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral Lacosamide (SPM 927) in Patients With Partial Seizures
Secondary ID [1] 0 0
2004-000152-16
Secondary ID [2] 0 0
SP0774
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
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lacosamide

Experimental: Lacosamide - 50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing


Treatment: Drugs: Lacosamide
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)
Timepoint [1] 0 0
During the Treatment Period (up to 5.5 years)
Primary outcome [2] 0 0
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)
Timepoint [2] 0 0
During the Treatment Period (up to 5.5 years)
Primary outcome [3] 0 0
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 Years)
Timepoint [3] 0 0
During the Treatment Period (up to 5.5 years)
Secondary outcome [1] 0 0
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years)
Timepoint [1] 0 0
Baseline, Treatment Period (up to 5.5 years)
Secondary outcome [2] 0 0
Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years)
Timepoint [2] 0 0
Treatment Period (up to 5.5 years)

Eligibility
Key inclusion criteria
* diagnosis of Epilepsy
* completion of double blind trial
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* taking other investigational drug than Lacosamide
* meeting withdrawal criteria from double blind trial

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Single group
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
1/12/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
Accrual to date
Final
376
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Randwick
Recruitment hospital [2] 0 0
- Maroochydore
Recruitment hospital [3] 0 0
- Woodville
Recruitment hospital [4] 0 0
- Clayton
Recruitment hospital [5] 0 0
- Parkville
Recruitment hospital [6] 0 0
- West Heidelberg
Recruitment hospital [7] 0 0
- Adelaide
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment postcode(s) [2] 0 0
- Maroochydore
Recruitment postcode(s) [3] 0 0
- Woodville
Recruitment postcode(s) [4] 0 0
- Clayton
Recruitment postcode(s) [5] 0 0
- Parkville
Recruitment postcode(s) [6] 0 0
- West Heidelberg
Recruitment postcode(s) [7] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
Croatia
State/province [1] 0 0
Zagreb
Country [2] 0 0
Czechia
State/province [2] 0 0
Brno
Country [3] 0 0
Czechia
State/province [3] 0 0
Hradec Kralove
Country [4] 0 0
Czechia
State/province [4] 0 0
Olomouc
Country [5] 0 0
Czechia
State/province [5] 0 0
Ostrava-Trebovice
Country [6] 0 0
Czechia
State/province [6] 0 0
Plzen
Country [7] 0 0
Czechia
State/province [7] 0 0
Prague
Country [8] 0 0
Finland
State/province [8] 0 0
Helsinki
Country [9] 0 0
Finland
State/province [9] 0 0
Kuopio
Country [10] 0 0
Finland
State/province [10] 0 0
Oulu
Country [11] 0 0
Finland
State/province [11] 0 0
Tampere
Country [12] 0 0
France
State/province [12] 0 0
Lille
Country [13] 0 0
France
State/province [13] 0 0
Lyon
Country [14] 0 0
France
State/province [14] 0 0
Montpellier
Country [15] 0 0
France
State/province [15] 0 0
Paris
Country [16] 0 0
France
State/province [16] 0 0
Toulouse
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
Country [18] 0 0
Germany
State/province [18] 0 0
Erlangen
Country [19] 0 0
Germany
State/province [19] 0 0
Göttingen
Country [20] 0 0
Germany
State/province [20] 0 0
Marburg
Country [21] 0 0
Germany
State/province [21] 0 0
München
Country [22] 0 0
Germany
State/province [22] 0 0
Ulm
Country [23] 0 0
Hungary
State/province [23] 0 0
Budapest
Country [24] 0 0
Hungary
State/province [24] 0 0
Pécs
Country [25] 0 0
Hungary
State/province [25] 0 0
Szeged
Country [26] 0 0
Hungary
State/province [26] 0 0
Szombathely
Country [27] 0 0
Lithuania
State/province [27] 0 0
Kaunas
Country [28] 0 0
Lithuania
State/province [28] 0 0
Vilnius
Country [29] 0 0
Poland
State/province [29] 0 0
Bialystok
Country [30] 0 0
Poland
State/province [30] 0 0
Gdansk
Country [31] 0 0
Poland
State/province [31] 0 0
Krakow
Country [32] 0 0
Poland
State/province [32] 0 0
Warsaw
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Moscow
Country [34] 0 0
Russian Federation
State/province [34] 0 0
St. Petersburg
Country [35] 0 0
Spain
State/province [35] 0 0
Girona
Country [36] 0 0
Spain
State/province [36] 0 0
Granada
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Spain
State/province [38] 0 0
Zaragoza
Country [39] 0 0
Sweden
State/province [39] 0 0
Gothenburg
Country [40] 0 0
Sweden
State/province [40] 0 0
Linköping
Country [41] 0 0
Sweden
State/province [41] 0 0
Stockholm
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Cardiff
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Dundee
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Glasgow
Country [45] 0 0
United Kingdom
State/province [45] 0 0
London
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Salford
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Swansea

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
Address 0 0
+1 877 822 9493
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Borghs S, de la Loge C, Brabant Y, Cramer J. Sensi... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00515619