Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Query!
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
Query!
Secondary ID [1]
0
0
2007-005439-27
Query!
Secondary ID [2]
0
0
SP0902
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ALEX-MT
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Epilepsy
0
0
Query!
Condition category
Condition code
Neurological
0
0
0
0
Query!
Epilepsy
Query!
Neurological
0
0
0
0
Query!
Other neurological disorders
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
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)
Query!
Assessment method [1]
0
0
Pre-defined exit criteria:
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
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
Occurrence of a single generalized tonic-clonic seizure if none had occurred in the 6 months prior to randomization
A prolongation or worsening of overall seizure duration, frequency, type or pattern considered by the investigator as serious enough to warrant trial discontinuation
Status epilepticus, or new onset of serial/cluster seizures
Query!
Timepoint [1]
0
0
16 Weeks Maintenance Period (approximately 112 days)
Query!
Secondary outcome [1]
0
0
Time to First Occurrence of Any Exit Event During The Maintenance Period
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
16 Weeks Maintenance Period (approximately 112 days)
Query!
Secondary outcome [2]
0
0
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
Query!
Assessment method [2]
0
0
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:
Met at least 1 exit criterion based on the calculations applied for the Primary Efficacy Analysis
Withdrawal due to AE with onset during the Maintenance Phase
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.
Query!
Timepoint [2]
0
0
16 Weeks Maintenance Period (approximately 112 days)
Query!
Secondary outcome [3]
0
0
Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Visit 9 - Visit 12 (approximately 10 weeks)
Query!
Secondary outcome [4]
0
0
Clinical Global Impression of Change (CGIC) From Baseline To Last Visit
Query!
Assessment method [4]
0
0
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:
Very much improved
Much improved
Minimally improved
No change
Minimally worse
Much worse
Very much worse
Query!
Timepoint [4]
0
0
Baseline; Last Visit (approximately 27 weeks)
Query!
Secondary outcome [5]
0
0
Patient's Global Impression of Change (PGIC) From Baseline To Last Visit
Query!
Assessment method [5]
0
0
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.)
Very much improved
Much improved
Minimally improved
No change
Minimally worse
Much worse
Very much worse
Query!
Timepoint [5]
0
0
Baseline; Last Visit (approximately 27 weeks)
Query!
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
Query!
Minimum age
16
Years
Query!
Query!
Maximum age
70
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/08/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/12/2012
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
426
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
421 - Capmerdown
Query!
Recruitment hospital [2]
0
0
425 - Chatswood
Query!
Recruitment hospital [3]
0
0
423 - Herston
Query!
Recruitment hospital [4]
0
0
422 - Maroochydore
Query!
Recruitment hospital [5]
0
0
420 - Adelaide
Query!
Recruitment hospital [6]
0
0
429 - Clayton
Query!
Recruitment hospital [7]
0
0
427 - Parkville
Query!
Recruitment postcode(s) [1]
0
0
- Capmerdown
Query!
Recruitment postcode(s) [2]
0
0
- Chatswood
Query!
Recruitment postcode(s) [3]
0
0
- Herston
Query!
Recruitment postcode(s) [4]
0
0
- Maroochydore
Query!
Recruitment postcode(s) [5]
0
0
- Adelaide
Query!
Recruitment postcode(s) [6]
0
0
- Clayton
Query!
Recruitment postcode(s) [7]
0
0
- Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Connecticut
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Delaware
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
District of Columbia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Florida
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Georgia
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Idaho
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Illinois
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Indiana
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Iowa
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Kansas
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Kentucky
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Maine
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Maryland
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Michigan
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Minnesota
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Mississippi
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Missouri
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Nebraska
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
New Hampshire
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
New Jersey
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
New York
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
North Carolina
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Ohio
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Oklahoma
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Oregon
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Pennsylvania
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
South Carolina
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Tennessee
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Texas
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Utah
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Virginia
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
Washington
Query!
Country [38]
0
0
United States of America
Query!
State/province [38]
0
0
Wisconsin
Query!
Country [39]
0
0
Austria
Query!
State/province [39]
0
0
Innsbruck
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Alberta
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Nova Scotia
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Ontario
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Quebec
Query!
Country [44]
0
0
Denmark
Query!
State/province [44]
0
0
Aarhus
Query!
Country [45]
0
0
Denmark
Query!
State/province [45]
0
0
Copenhagen
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Bron
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Dijon
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Ramonville Saint Agne
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Berlin
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Mainz
Query!
Country [51]
0
0
Ireland
Query!
State/province [51]
0
0
Dublin
Query!
Country [52]
0
0
Italy
Query!
State/province [52]
0
0
Bologna
Query!
Country [53]
0
0
Italy
Query!
State/province [53]
0
0
Catanzaro
Query!
Country [54]
0
0
Italy
Query!
State/province [54]
0
0
Ferrara
Query!
Country [55]
0
0
Italy
Query!
State/province [55]
0
0
Milano
Query!
Country [56]
0
0
Italy
Query!
State/province [56]
0
0
Perugia
Query!
Country [57]
0
0
Italy
Query!
State/province [57]
0
0
Pisa
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Reggio Calabria
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Torrette Di Ancona
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Czestochowa
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Gdansk
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Gdynia
Query!
Country [63]
0
0
Poland
Query!
State/province [63]
0
0
Krakow
Query!
Country [64]
0
0
Poland
Query!
State/province [64]
0
0
Lublin
Query!
Country [65]
0
0
Poland
Query!
State/province [65]
0
0
Szczecin
Query!
Country [66]
0
0
Poland
Query!
State/province [66]
0
0
Warszawa
Query!
Country [67]
0
0
Puerto Rico
Query!
State/province [67]
0
0
San Juan
Query!
Country [68]
0
0
Spain
Query!
State/province [68]
0
0
Granada
Query!
Country [69]
0
0
Spain
Query!
State/province [69]
0
0
Santa Cruz De Tenerife
Query!
Country [70]
0
0
United Kingdom
Query!
State/province [70]
0
0
Blackpool
Query!
Country [71]
0
0
United Kingdom
Query!
State/province [71]
0
0
London
Query!
Country [72]
0
0
United Kingdom
Query!
State/province [72]
0
0
Manchester
Query!
Country [73]
0
0
United Kingdom
Query!
State/province [73]
0
0
Middlesborough
Query!
Country [74]
0
0
United Kingdom
Query!
State/province [74]
0
0
Stoke on Trent
Query!
Country [75]
0
0
United Kingdom
Query!
State/province [75]
0
0
Truro
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
UCB BIOSCIENCES, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00520741
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
UCB Clinical Trial Call Center
Query!
Address
0
0
+1 877 822 9493 (UCB)
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00520741
Download to PDF