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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00520741
Registration number
NCT00520741
Ethics application status
Date submitted
24/08/2007
Date registered
27/08/2007
Date last updated
19/07/2018
Titles & IDs
Public title
Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures
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Scientific title
A Historical-controlled, Multicenter, Double-blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400 mg/Day Monotherapy in Subjects With Partial-onset Seizures
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Secondary ID [1]
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2007-005439-27
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Secondary ID [2]
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SP0902
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Universal Trial Number (UTN)
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Trial acronym
ALEX-MT
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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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Condition category
Condition code
Neurological
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Epilepsy
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Neurological
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Other neurological disorders
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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 - Lacosamide
Experimental: Lacosamide 400 mg/day - Lacosamide 400 mg/day
Active comparator: Lacosamide 300 mg/day - Lacosamide 300 mg/day
Treatment: Drugs: Lacosamide
50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
Treatment: Drugs: Lacosamide
50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
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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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Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s)
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Assessment method [1]
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Pre-defined exit criteria:
1. A 2-fold or greater increase in average monthly (28-day) partial seizure frequency (motor and non-motor) compared to average monthly partial seizure frequency (motor and non-motor) during the Baseline Phase
2. A 2-fold or greater increase in consecutive 2-day partial seizure frequency (motor and non-motor) versus the highest consecutive 2-day partial seizure frequency (motor and non-motor) that occurred during the Baseline Phase.
Note: if the highest consecutive 2-day partial seizure frequency during the Baseline Phase is 1, a 2-day partial seizure frequency of =3 is required to meet this exit criterion
3. Occurrence of a single generalized tonic-clonic seizure if none had occurred in the 6 months prior to randomization
4. A prolongation or worsening of overall seizure duration, frequency, type or pattern considered by the investigator as serious enough to warrant trial discontinuation
5. Status epilepticus, or new onset of serial/cluster seizures
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Timepoint [1]
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16 Weeks Maintenance Period (approximately 112 days)
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Secondary outcome [1]
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Time to First Occurrence of Any Exit Event During The Maintenance Period
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Assessment method [1]
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The time to first occurrence (days) of any exit event was estimated using Kaplan-Meier methods and was based on the time from the start of the Maintenance Phase to the earliest date a subject met an exit criterion. Subjects who discontinued during the Maintenance Phase due to non-exit criteria reasons or who completed the Maintenance Phase before 112 days and did not meet an exit criterion were censored as of the last Maintenance Phase dose date. Subjects completing 112 days in the Maintenance Phase were censored as of Day 112.
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Timepoint [1]
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16 Weeks Maintenance Period (approximately 112 days)
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Secondary outcome [2]
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Percentage of Subjects (Using Kaplan-Meier) Who Are Identified as Meeting at Least 1 Pre-defined Exit Criteria by Day 112, Withdrew Due to Adverse Event (AE) or Withdrew Due to Lack of Efficacy During The Maintenance Period
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Assessment method [2]
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Subjects were classified as having an exit event if they experienced at least 1 of the following events during the Maintenance Phase as of Day 112:
1. Met at least 1 exit criterion based on the calculations applied for the Primary Efficacy Analysis
2. Withdrawal due to AE with onset during the Maintenance Phase
3. Withdrew prematurely due to lack of efficacy during the Maintenance Phase
The date the subject experienced the event was set to the earliest date the subject met an exit criterion or the date of the last Maintenance Phase dose for subjects not meeting an exit criterion but withdrawing due to an AE or lack of efficacy.
The secondary analysis is only conducted on the Lacosamide 400 mg/day group.
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Timepoint [2]
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16 Weeks Maintenance Period (approximately 112 days)
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Secondary outcome [3]
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Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)
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Assessment method [3]
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Days on Monotherapy Treatment were defined as the number of days during the Monotherapy Phase when the subject took Lacosamide (LCM) only (ie, the total number of days exposed to LCM during the Monotherapy Phase minus any days where a concomitant or rescue Anti-epileptic Drug (AED) was taken by the subject). The days on Monotherapy Treatment did not need to be consecutive.
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Timepoint [3]
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Visit 9 - Visit 12 (approximately 10 weeks)
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Secondary outcome [4]
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Clinical Global Impression of Change (CGIC) From Baseline To Last Visit
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Assessment method [4]
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For the assessment of the Clinical Global Impression of Change (CGIC), the investigator should provide his/her assessment of the subject's clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status. He was asked the following:Please check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:
1. Very much improved
2. Much improved
3. Minimally improved
4. No change
5. Minimally worse
6. Much worse
7. Very much worse
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Timepoint [4]
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Baseline; Last Visit (approximately 27 weeks)
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Secondary outcome [5]
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Patient's Global Impression of Change (PGIC) From Baseline To Last Visit
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Assessment method [5]
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For the assessment of the Patient's Global Impression of Change, the subject should provide his/her assessment of his/her own clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status.The subject was asked to answer the following:
Over the past 4 weeks, how have you felt compared to before you entered this clinical trial? (Please check the number that best describes your condition.)
1. Very much improved
2. Much improved
3. Minimally improved
4. No change
5. Minimally worse
6. Much worse
7. Very much worse
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Timepoint [5]
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Baseline; Last Visit (approximately 27 weeks)
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Eligibility
Key inclusion criteria
* Subject has a diagnosis of Epilepsy with Simple Partial Seizures (motor component) and or Complex Partial Seizures (with or without secondary generalization)
* Must be experiencing 2 to 40 seizures per 28-day period
* Stable dose of 1 or 2 marketed antiepileptic drugs
* Second Antiepileptic Drug (AED) must be less than or equal to 50 % of the minimum recommended maintenance dose per USA product label at screening
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Minimum age
16
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Maximum age
70
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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 has a history of primary generalized or unclassified seizures
* Seizure disorder primarily characterized by isolated auras
* History of status epilepticus
* Seizures that are uncountable due to clustering
* Has greater than 5 seizures/day
* Subjects taking Benzodiazepines, Phenobarbital or Primidone
* Subject has Vagus Nerve Stimulation (VNS)
* Significant medical or psychiatric condition
* History of alcohol or drug abuse
* History of Ethosuximide use, Felbamate use after 1994 or Vigabatrin use after 1997
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
1/08/2007
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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
1/12/2012
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Sample size
Target
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Accrual to date
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Final
426
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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421 - Capmerdown
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Recruitment hospital [2]
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425 - Chatswood
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423 - Herston
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422 - Maroochydore
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420 - Adelaide
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Recruitment hospital [6]
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429 - Clayton
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427 - Parkville
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- Capmerdown
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- Chatswood
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- Herston
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- Maroochydore
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- Adelaide
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- Clayton
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- Parkville
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Truro
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
UCB BIOSCIENCES, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.
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Trial website
https://clinicaltrials.gov/study/NCT00520741
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Trial related presentations / publications
Wechsler RT, Li G, French J, O'Brien TJ, D'Cruz O, Williams P, Goodson R, Brock M; ALEX-MT Study Group. Conversion to lacosamide monotherapy in the treatment of focal epilepsy: results from a historical-controlled, multicenter, double-blind study. Epilepsia. 2014 Jul;55(7):1088-98. doi: 10.1111/epi.12681. Epub 2014 Jun 10.
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Public notes
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Contacts
Principal investigator
Name
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UCB Clinical Trial Call Center
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Address
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+1 877 822 9493 (UCB)
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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
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00520741
Download to PDF