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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
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)
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
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
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)
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
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
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
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Alabama
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Blackpool
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Middlesborough
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Stoke on Trent
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Truro

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00520741
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.
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
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/study/NCT00520741