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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00530855




Registration number
NCT00530855
Ethics application status
Date submitted
14/09/2007
Date registered
18/09/2007
Date last updated
18/07/2018

Titles & IDs
Public title
Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures
Scientific title
A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects With Partial-onset Seizures
Secondary ID [1] 0 0
2007-005440-25
Secondary ID [2] 0 0
SP0904
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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Lacosamide

Experimental: Lacosamide - Lacosamide tablets for dosing 100 -800 mg/day


Treatment: Drugs: Lacosamide
50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years

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

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study - Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.
Timepoint [1] 0 0
From Visit 1 to End of Study (approximately 2 years)
Primary outcome [2] 0 0
Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study - Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.
Timepoint [2] 0 0
From Visit 1 to End of Study (approximately 2 years)
Secondary outcome [1] 0 0
Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study - A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.
An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).
Timepoint [1] 0 0
From Visit 1 to End of Study (approximately 2 years)
Secondary outcome [2] 0 0
Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study
Timepoint [2] 0 0
From Visit 1 to End of Study (approximately 2 years)

Eligibility
Key inclusion criteria
- Subject has entered the Maintenance Phase of the double-blind trial, SP902, (ie, has
taken at least 1 dose of SP902 Maintenance Phase trial medication) and either
completed SP902 or met an exit criterion in SP902; subject is allowed up to 2
concomitant Antiepileptic Drugs (AEDs)
Minimum age
16 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial,
or is experiencing an ongoing Serious Adverse Event (SAE)

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
421 - Capmerdown
Recruitment hospital [2] 0 0
425 - Chatswood
Recruitment hospital [3] 0 0
423 - Herston
Recruitment hospital [4] 0 0
420 - Adelaide
Recruitment hospital [5] 0 0
427 - Parkville
Recruitment postcode(s) [1] 0 0
- Capmerdown
Recruitment postcode(s) [2] 0 0
- Chatswood
Recruitment postcode(s) [3] 0 0
- Herston
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment postcode(s) [5] 0 0
- Parkville
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
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Iowa
Country [13] 0 0
United States of America
State/province [13] 0 0
Kansas
Country [14] 0 0
United States of America
State/province [14] 0 0
Kentucky
Country [15] 0 0
United States of America
State/province [15] 0 0
Maine
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
Country [17] 0 0
United States of America
State/province [17] 0 0
Michigan
Country [18] 0 0
United States of America
State/province [18] 0 0
Minnesota
Country [19] 0 0
United States of America
State/province [19] 0 0
Mississippi
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
New Hampshire
Country [22] 0 0
United States of America
State/province [22] 0 0
New Jersey
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
North Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oklahoma
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
Tennessee
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Utah
Country [32] 0 0
United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
Country [34] 0 0
United States of America
State/province [34] 0 0
Wisconsin
Country [35] 0 0
Canada
State/province [35] 0 0
Nova Scotia
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
Canada
State/province [38] 0 0
Calgary
Country [39] 0 0
Denmark
State/province [39] 0 0
Aarhus
Country [40] 0 0
Germany
State/province [40] 0 0
Mainz
Country [41] 0 0
Italy
State/province [41] 0 0
Ferrara
Country [42] 0 0
Italy
State/province [42] 0 0
Reggio Calabria
Country [43] 0 0
Italy
State/province [43] 0 0
Torrette Di Ancona
Country [44] 0 0
Poland
State/province [44] 0 0
Czestochowa
Country [45] 0 0
Poland
State/province [45] 0 0
Gdansk
Country [46] 0 0
Poland
State/province [46] 0 0
Gdynia
Country [47] 0 0
Poland
State/province [47] 0 0
Krakow
Country [48] 0 0
Poland
State/province [48] 0 0
Lublin
Country [49] 0 0
Poland
State/province [49] 0 0
Szczecin
Country [50] 0 0
Poland
State/province [50] 0 0
Warszawa
Country [51] 0 0
Spain
State/province [51] 0 0
Santa Cruz de Tenerife
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Blackpool
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Cornwall
Country [54] 0 0
United Kingdom
State/province [54] 0 0
London
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Middlesborough

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

Ethics approval
Ethics application status

Summary
Brief summary
This open-label extension trial will assess the long-term use of Lacosamide monotherapy and
safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset
seizures who were previously enrolled in the conversion to monotherapy trial (SP902).
Trial website
https://clinicaltrials.gov/show/NCT00530855
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
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