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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01465997




Registration number
NCT01465997
Ethics application status
Date submitted
2/11/2011
Date registered
6/11/2011
Date last updated
18/07/2018

Titles & IDs
Public title
Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
Scientific title
A Multicenter, Double-blind, Double-dummy, Follow up Study Evaluating the Long-term Safety of Lacosamide in Comparison With Controlled-release Carbamazepine Used as Monotherapy in Subjects With Partial-onset or Generalized Tonic-clonic Seizures =16 Years of Age Coming From the SP0993 Study.
Secondary ID [1] 0 0
2010-021238-74
Secondary ID [2] 0 0
SP0994
Universal Trial Number (UTN)
Trial acronym
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 (CBZ-CR)

Experimental: Lacosamide - 50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years)

Active Comparator: Carbamazepine-Controlled Release (CBZ-CR) - 200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years)


Treatment: Drugs: Lacosamide
50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years)

Treatment: Drugs: Carbamazepine-Controlled Release (CBZ-CR)
200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum 3.5 Years)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years)
Timepoint [1] 0 0
Up to 3.5 Years (Duration of the Treatment Phase)
Primary outcome [2] 0 0
Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years)
Timepoint [2] 0 0
Up to 3.5 Years (Duration of the Treatment Phase)
Primary outcome [3] 0 0
Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years)
Timepoint [3] 0 0
Up to 3.5 Years (Duration of the Treatment Phase)

Eligibility
Key inclusion criteria
- Subject/legal representative is considered reliable and capable of adhering to the
protocol

- Subject has remained seizure free and completed the Maintenance Phase of the SP0993;
or subject has experienced 1 or more seizures on the first or second target dose
during the SP0993 Maintenance Phase

- Subject is expected to benefit from participation in SP0994 in the opinion of the
investigator
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject is receiving any investigational drugs or using any experimental devices in
addition to LCM or CBZ-CR

- Subject experienced a seizure at the third target dose during the Evaluation Phase or
Maintenance Phase of the SP0993 study

- Subject is taking benzodiazepines for a non-epilepsy indication

- Subject meets a withdrawal criterion from the previous study SP0993

- Subject is experiencing an ongoing SAE from the previous study SP0993

- Subject has a lifetime history of suicide attempt (including an active 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. Or subject has a
positive response (Yes) to either Question 4 or Question 5 of the C-SSRS at Screening
in the "Since Last Visit" version

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2017
Sample size
Target
Accrual to date
Final
551
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
104 - Chatswood
Recruitment hospital [2] 0 0
105 - Clayton
Recruitment hospital [3] 0 0
106 - East Gosford
Recruitment hospital [4] 0 0
101 - Fitzroy
Recruitment hospital [5] 0 0
108 - Heidelberg
Recruitment hospital [6] 0 0
103 - Herston
Recruitment hospital [7] 0 0
109 - Randwick
Recruitment postcode(s) [1] 0 0
- Chatswood
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- East Gosford
Recruitment postcode(s) [4] 0 0
- Fitzroy
Recruitment postcode(s) [5] 0 0
- Heidelberg
Recruitment postcode(s) [6] 0 0
- Herston
Recruitment postcode(s) [7] 0 0
- Randwick
Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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Wisconsin
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Brugge
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Hasselt
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Leuven
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Blagoevgrad
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Pleven
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Russe
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Sofia
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Greenfield Park
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Hamilton
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Zlin
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Osnabrück
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Ioannina
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Biel
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Thailand
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Khon Kaen
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Ukraine
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Chernihiv
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Kharkov
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Odesa
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Simferopol
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United Kingdom
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Glasgow
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United Kingdom
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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 safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as
monotherapy in newly or recently newly diagnosed subjects with primary safety variables
including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs,
reporting of Serious AEs (SAEs).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01465997
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01465997