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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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) - Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
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) - Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
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) - A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.
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) - Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.
Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
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) - At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency
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
Gender
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
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
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
- 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
The main purpose of this trial is to determine safety and efficacy of Lacosamide under long
term therapy.
Trial website
https://clinicaltrials.gov/show/NCT00515619
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

Summary results
Other publications