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Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures (ALEX-MT)

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lacosamide
Lacosamide
Sponsored by
UCB BIOSCIENCES, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Partial Onset Seizures, Lacosamide, Monotherapy, Vimpat

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • 48
  • 10
  • 18
  • 42
  • 14
  • 151
  • 9
  • 150
  • 103
  • 102
  • 7
  • 86
  • 120
  • 156
  • 59
  • 76
  • 45
  • 21
  • 107
  • 60
  • 25
  • 133
  • 37
  • 94
  • 108
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  • 123
  • 132
  • 77
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  • 109
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  • 50
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  • 4
  • 163
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  • 40
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  • 160
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  • 119
  • 164
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  • 30
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  • 105
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  • 154
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  • 27
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  • 3
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  • 47
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  • 2
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  • 157
  • 100
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  • 114
  • 1
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  • 158
  • 323
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  • 360
  • 364
  • 369
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  • 368
  • 367

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lacosamide 400 mg/day

Lacosamide 300 mg/day

Arm Description

Lacosamide 400 mg/day

Lacosamide 300 mg/day

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

Time to First Occurrence of Any Exit Event During The Maintenance Period
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.
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
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.
Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)
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.
Clinical Global Impression of Change (CGIC) From Baseline To Last Visit
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
Patient's Global Impression of Change (PGIC) From Baseline To Last Visit
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

Full Information

First Posted
August 24, 2007
Last Updated
June 20, 2018
Sponsor
UCB BIOSCIENCES, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00520741
Brief Title
Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures
Acronym
ALEX-MT
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB BIOSCIENCES, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Sudden unexplained death in epilepsy have been reported in epilepsy patients. A causal relationship with the administration of antiepileptic drugs has not been established. The most important known risk factor for sudden unexplained death in epilepsy (SUDEP) is the occurrence and frequency of generalized tonic-clonic seizures (GTCS). Twenty-seven patients with only GTCS were enrolled in the conversion to monotherapy study. In this study, two patients with only GTCS had SUDEP. Due to the potential increased risk of SUDEP in patients with only GTCS in a trial setting, the 1 remaining patient with only GTCS was withdrawn from this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Partial Onset Seizures, Lacosamide, Monotherapy, Vimpat

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
426 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lacosamide 400 mg/day
Arm Type
Experimental
Arm Description
Lacosamide 400 mg/day
Arm Title
Lacosamide 300 mg/day
Arm Type
Active Comparator
Arm Description
Lacosamide 300 mg/day
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
Vimpat
Intervention Description
50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
Vimpat
Intervention Description
50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
Primary Outcome Measure Information:
Title
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)
Description
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
Time Frame
16 Weeks Maintenance Period (approximately 112 days)
Secondary Outcome Measure Information:
Title
Time to First Occurrence of Any Exit Event During The Maintenance Period
Description
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.
Time Frame
16 Weeks Maintenance Period (approximately 112 days)
Title
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
Description
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.
Time Frame
16 Weeks Maintenance Period (approximately 112 days)
Title
Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)
Description
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.
Time Frame
Visit 9 - Visit 12 (approximately 10 weeks)
Title
Clinical Global Impression of Change (CGIC) From Baseline To Last Visit
Description
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
Time Frame
Baseline; Last Visit (approximately 27 weeks)
Title
Patient's Global Impression of Change (PGIC) From Baseline To Last Visit
Description
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
Time Frame
Baseline; Last Visit (approximately 27 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
48
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Alabaster
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Alabama
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United States
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10
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Birmingham
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Alabama
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United States
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18
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Huntsville
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Alabama
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42
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Northport
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Alabama
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14
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Phoenix
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151
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Phoenix
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9
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Phoenix
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150
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Sun City
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Tucson
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102
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Jonesboro
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7
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Little Rock
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86
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Little Rock
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La Habra
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156
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Loma Linda
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California
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59
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Los Angeles
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California
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76
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Los Angeles
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California
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45
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Newport Beach
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California
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United States
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21
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Santa Monica
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California
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United States
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107
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Torrance
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California
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60
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Aurora
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Colorado
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25
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Fairfield
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Connecticut
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United States
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133
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Dover
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Delaware
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37
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Washington
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District of Columbia
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94
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Doral
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108
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Gainesville
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Florida
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United States
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130
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Gulf Breeze
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Florida
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55
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Maitland
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Florida
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United States
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123
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Miami
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Florida
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132
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Miami
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Florida
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United States
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77
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Orlando
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Florida
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United States
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49
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Panama City
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Florida
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United States
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109
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Pinellas Park
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Florida
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United States
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129
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Port Charlotte
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Florida
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United States
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50
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Sarasota
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Florida
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United States
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81
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Sarasota
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Florida
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United States
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4
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Tallahassee
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Florida
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United States
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163
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Tampa
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Florida
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United States
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79
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Atlanta
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Georgia
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United States
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72
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Canton
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Georgia
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United States
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40
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Savannah
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Georgia
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United States
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58
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Boise
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Idaho
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United States
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131
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Hines
State/Province
Illinois
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United States
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146
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Peoria
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Illinois
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United States
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11
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Springfield
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Illinois
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United States
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78
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Indianapolis
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Indiana
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United States
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73
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Ames
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Iowa
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United States
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124
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Manhattan
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Kansas
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United States
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160
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Wichita
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Kansas
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United States
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23
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Wichita
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Kansas
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United States
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119
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Lexington
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Kentucky
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United States
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164
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Lexington
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Kentucky
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United States
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62
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Louisville
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Kentucky
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United States
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29
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Scarborough
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Maine
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United States
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20
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Baltimore
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Maryland
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United States
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34
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Baltimore
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Maryland
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United States
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19
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Bethesda
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Maryland
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United States
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65
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Pikesville
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Maryland
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United States
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137
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Waldorf
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Maryland
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United States
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41
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Detroit
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Michigan
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United States
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30
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Golden Valley
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Minnesota
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United States
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71
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Hattiesburg
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Mississippi
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United States
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31
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Chesterfield
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Missouri
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United States
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105
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Columbia
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Missouri
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United States
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66
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Saint Louis
State/Province
Missouri
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United States
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174
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Omaha
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Nebraska
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United States
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17
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Lebanon
State/Province
New Hampshire
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United States
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43
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Edison
State/Province
New Jersey
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United States
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67
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Voorhees
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New Jersey
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United States
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36
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Albany
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New York
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United States
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83
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Buffalo
State/Province
New York
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United States
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69
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Cedarhurst
State/Province
New York
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United States
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154
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Mineola
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New York
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United States
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122
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New York
State/Province
New York
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United States
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27
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New York
State/Province
New York
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United States
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175
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Schenectady
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New York
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United States
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3
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Asheville
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North Carolina
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United States
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63
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Durham
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North Carolina
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United States
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152
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Rocky Mount
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North Carolina
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United States
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117
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Wilmington
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North Carolina
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United States
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47
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Winston-Salem
State/Province
North Carolina
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United States
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15
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Cleveland
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Ohio
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United States
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61
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Columbus
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Ohio
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United States
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2
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Toledo
State/Province
Ohio
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United States
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147
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Oklahoma City
State/Province
Oklahoma
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United States
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8
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Medford
State/Province
Oregon
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United States
Facility Name
157
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Portland
State/Province
Oregon
Country
United States
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100
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Greensburg
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Pennsylvania
Country
United States
Facility Name
32
City
Philadelphia
State/Province
Pennsylvania
Country
United States
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26
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Tarentum
State/Province
Pennsylvania
Country
United States
Facility Name
24
City
Beaufort
State/Province
South Carolina
Country
United States
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114
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
1
City
Nashville
State/Province
Tennessee
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United States
Facility Name
138
City
Austin
State/Province
Texas
Country
United States
Facility Name
111
City
Dallas
State/Province
Texas
Country
United States
Facility Name
22
City
Dallas
State/Province
Texas
Country
United States
Facility Name
46
City
El Paso
State/Province
Texas
Country
United States
Facility Name
51
City
Houston
State/Province
Texas
Country
United States
Facility Name
53
City
Houston
State/Province
Texas
Country
United States
Facility Name
98
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
82
City
Temple
State/Province
Texas
Country
United States
Facility Name
136
City
Layton
State/Province
Utah
Country
United States
Facility Name
161
City
Alexandria
State/Province
Virginia
Country
United States
Facility Name
16
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
106
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
125
City
Winchester
State/Province
Virginia
Country
United States
Facility Name
74
City
Renton
State/Province
Washington
Country
United States
Facility Name
80
City
Madison
State/Province
Wisconsin
Country
United States
Facility Name
28
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
421
City
Capmerdown
State/Province
New South Wales
Country
Australia
Facility Name
425
City
Chatswood
State/Province
New South Wales
Country
Australia
Facility Name
423
City
Herston
State/Province
Queensland
Country
Australia
Facility Name
422
City
Maroochydore
State/Province
Queensland
Country
Australia
Facility Name
420
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
429
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
427
City
Parkville
State/Province
Victoria
Country
Australia
Facility Name
204
City
Innsbruck
Country
Austria
Facility Name
127
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
140
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
116
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
93
City
London
State/Province
Ontario
Country
Canada
Facility Name
91
City
Greenfield Park
State/Province
Quebec
Country
Canada
Facility Name
110
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
113
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
223
City
Aarhus
Country
Denmark
Facility Name
220
City
Copenhagen
Country
Denmark
Facility Name
402
City
Bron
Country
France
Facility Name
404
City
Dijon
Country
France
Facility Name
405
City
Ramonville Saint Agne
Country
France
Facility Name
465
City
Berlin
Country
Germany
Facility Name
461
City
Mainz
Country
Germany
Facility Name
240
City
Dublin
Country
Ireland
Facility Name
442
City
Bologna
Country
Italy
Facility Name
449
City
Catanzaro
Country
Italy
Facility Name
443
City
Ferrara
Country
Italy
Facility Name
441
City
Milano
Country
Italy
Facility Name
450
City
Perugia
Country
Italy
Facility Name
448
City
Pisa
Country
Italy
Facility Name
445
City
Reggio Calabria
Country
Italy
Facility Name
447
City
Torrette Di Ancona
Country
Italy
Facility Name
284
City
Czestochowa
Country
Poland
Facility Name
286
City
Gdansk
Country
Poland
Facility Name
282
City
Gdynia
Country
Poland
Facility Name
280
City
Krakow
Country
Poland
Facility Name
283
City
Lublin
Country
Poland
Facility Name
290
City
Lublin
Country
Poland
Facility Name
289
City
Szczecin
Country
Poland
Facility Name
281
City
Warszawa
Country
Poland
Facility Name
287
City
Warszawa
Country
Poland
Facility Name
158
City
San Juan
Country
Puerto Rico
Facility Name
323
City
Granada
Country
Spain
Facility Name
324
City
Santa Cruz De Tenerife
Country
Spain
Facility Name
360
City
Blackpool
Country
United Kingdom
Facility Name
364
City
London
Country
United Kingdom
Facility Name
369
City
London
Country
United Kingdom
Facility Name
361
City
Manchester
Country
United Kingdom
Facility Name
363
City
Middlesborough
Country
United Kingdom
Facility Name
368
City
Stoke on Trent
Country
United Kingdom
Facility Name
367
City
Truro
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24915838
Citation
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.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA safety Alerts and Recalls

Learn more about this trial

Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures

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