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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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.
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Secondary ID [1]
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0
2010-021238-74
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Secondary ID [2]
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SP0994
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Epilepsy
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0
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Monotherapy
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Condition category
Condition code
Neurological
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0
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Epilepsy
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Intervention/exposure
Study type
Interventional(has expanded access)
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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)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years)
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Assessment method [1]
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Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.
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Timepoint [1]
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Up to 3.5 Years (Duration of the Treatment Phase)
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Primary outcome [2]
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Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years)
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Assessment method [2]
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Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.
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Timepoint [2]
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Up to 3.5 Years (Duration of the Treatment Phase)
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Primary outcome [3]
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Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years)
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Assessment method [3]
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A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.
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Timepoint [3]
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Up to 3.5 Years (Duration of the Treatment Phase)
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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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2017
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Sample size
Target
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Accrual to date
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Final
551
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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104 - Chatswood
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Recruitment hospital [2]
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105 - Clayton
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106 - East Gosford
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101 - Fitzroy
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108 - Heidelberg
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Recruitment hospital [6]
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103 - Herston
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Recruitment hospital [7]
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109 - Randwick
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Recruitment postcode(s) [1]
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- Chatswood
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Recruitment postcode(s) [2]
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- Clayton
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- East Gosford
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- Fitzroy
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- Heidelberg
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- Herston
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Recruitment postcode(s) [7]
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- Randwick
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Recruitment outside Australia
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United States of America
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Alabama
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Manila
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Portugal
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Santa Maria da Feira
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Bucuresti
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Russian Federation
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Yaroslavl
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Slovakia
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Dolni Kubin
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Hlohovec
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
UCB BIOSCIENCES GmbH
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Eden Sarl
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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).
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Trial website
https://clinicaltrials.gov/study/NCT01465997
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Trial related presentations / publications
Ben-Menachem E, Dominguez J, Szasz J, Beller C, Howerton C, Jensen L, McClung C, Roebling R, Steiniger-Brach B. Long-term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open-label trial. Epilepsia Open. 2021 Sep;6(3):618-623. doi: 10.1002/epi4.12522. Epub 2021 Aug 2.
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Public notes
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Contacts
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UCB Cares
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+1 877 822 9493 (UCB)
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
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Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01465997
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