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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01058954




Registration number
NCT01058954
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
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
Secondary ID [1] 0 0
2007-005439-27
Secondary ID [2] 0 0
SP0902
Universal Trial Number (UTN)
Trial acronym
ALEX-MT
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
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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)
Assessment method [1] 0 0
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
Timepoint [1] 0 0
16 Weeks Maintenance Period (approximately 112 days)
Secondary outcome [1] 0 0
Time to First Occurrence of Any Exit Event During The Maintenance Period
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.
Timepoint [1] 0 0
16 Weeks Maintenance Period (approximately 112 days)
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
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: 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.
Timepoint [2] 0 0
16 Weeks Maintenance Period (approximately 112 days)
Secondary outcome [3] 0 0
Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)
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.
Timepoint [3] 0 0
Visit 9 - Visit 12 (approximately 10 weeks)
Secondary outcome [4] 0 0
Clinical Global Impression of Change (CGIC) From Baseline To Last Visit
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: 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse
Timepoint [4] 0 0
Baseline; Last Visit (approximately 27 weeks)
Secondary outcome [5] 0 0
Patient's Global Impression of Change (PGIC) From Baseline To Last Visit
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.) 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse
Timepoint [5] 0 0
Baseline; Last Visit (approximately 27 weeks)

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
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
426
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
422 - Maroochydore
Recruitment hospital [5] 0 0
420 - Adelaide
Recruitment hospital [6] 0 0
429 - Clayton
Recruitment hospital [7] 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
- Maroochydore
Recruitment postcode(s) [5] 0 0
- Adelaide
Recruitment postcode(s) [6] 0 0
- Clayton
Recruitment postcode(s) [7] 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
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Idaho
Country [12] 0 0
United States of America
State/province [12] 0 0
Illinois
Country [13] 0 0
United States of America
State/province [13] 0 0
Indiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Iowa
Country [15] 0 0
United States of America
State/province [15] 0 0
Kansas
Country [16] 0 0
United States of America
State/province [16] 0 0
Kentucky
Country [17] 0 0
United States of America
State/province [17] 0 0
Maine
Country [18] 0 0
United States of America
State/province [18] 0 0
Maryland
Country [19] 0 0
United States of America
State/province [19] 0 0
Michigan
Country [20] 0 0
United States of America
State/province [20] 0 0
Minnesota
Country [21] 0 0
United States of America
State/province [21] 0 0
Mississippi
Country [22] 0 0
United States of America
State/province [22] 0 0
Missouri
Country [23] 0 0
United States of America
State/province [23] 0 0
Nebraska
Country [24] 0 0
United States of America
State/province [24] 0 0
New Hampshire
Country [25] 0 0
United States of America
State/province [25] 0 0
New Jersey
Country [26] 0 0
United States of America
State/province [26] 0 0
New York
Country [27] 0 0
United States of America
State/province [27] 0 0
North Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
Ohio
Country [29] 0 0
United States of America
State/province [29] 0 0
Oklahoma
Country [30] 0 0
United States of America
State/province [30] 0 0
Oregon
Country [31] 0 0
United States of America
State/province [31] 0 0
Pennsylvania
Country [32] 0 0
United States of America
State/province [32] 0 0
South Carolina
Country [33] 0 0
United States of America
State/province [33] 0 0
Tennessee
Country [34] 0 0
United States of America
State/province [34] 0 0
Texas
Country [35] 0 0
United States of America
State/province [35] 0 0
Utah
Country [36] 0 0
United States of America
State/province [36] 0 0
Virginia
Country [37] 0 0
United States of America
State/province [37] 0 0
Washington
Country [38] 0 0
United States of America
State/province [38] 0 0
Wisconsin
Country [39] 0 0
Austria
State/province [39] 0 0
Innsbruck
Country [40] 0 0
Canada
State/province [40] 0 0
Alberta
Country [41] 0 0
Canada
State/province [41] 0 0
Nova Scotia
Country [42] 0 0
Canada
State/province [42] 0 0
Ontario
Country [43] 0 0
Canada
State/province [43] 0 0
Quebec
Country [44] 0 0
Denmark
State/province [44] 0 0
Aarhus
Country [45] 0 0
Denmark
State/province [45] 0 0
Copenhagen
Country [46] 0 0
France
State/province [46] 0 0
Bron
Country [47] 0 0
France
State/province [47] 0 0
Dijon
Country [48] 0 0
France
State/province [48] 0 0
Ramonville Saint Agne
Country [49] 0 0
Germany
State/province [49] 0 0
Berlin
Country [50] 0 0
Germany
State/province [50] 0 0
Mainz
Country [51] 0 0
Ireland
State/province [51] 0 0
Dublin
Country [52] 0 0
Italy
State/province [52] 0 0
Bologna
Country [53] 0 0
Italy
State/province [53] 0 0
Catanzaro
Country [54] 0 0
Italy
State/province [54] 0 0
Ferrara
Country [55] 0 0
Italy
State/province [55] 0 0
Milano
Country [56] 0 0
Italy
State/province [56] 0 0
Perugia
Country [57] 0 0
Italy
State/province [57] 0 0
Pisa
Country [58] 0 0
Italy
State/province [58] 0 0
Reggio Calabria
Country [59] 0 0
Italy
State/province [59] 0 0
Torrette Di Ancona
Country [60] 0 0
Poland
State/province [60] 0 0
Czestochowa
Country [61] 0 0
Poland
State/province [61] 0 0
Gdansk
Country [62] 0 0
Poland
State/province [62] 0 0
Gdynia
Country [63] 0 0
Poland
State/province [63] 0 0
Krakow
Country [64] 0 0
Poland
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Lublin
Country [65] 0 0
Poland
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Szczecin
Country [66] 0 0
Poland
State/province [66] 0 0
Warszawa
Country [67] 0 0
Puerto Rico
State/province [67] 0 0
San Juan
Country [68] 0 0
Spain
State/province [68] 0 0
Granada
Country [69] 0 0
Spain
State/province [69] 0 0
Santa Cruz De Tenerife
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Blackpool
Country [71] 0 0
United Kingdom
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London
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Manchester
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Middlesborough
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Stoke on Trent
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB BIOSCIENCES, Inc.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
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/NCT01058954