Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures
ALEX-MT
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
2 other identifiers
interventional
426
12 countries
157
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the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2007
Longer than P75 for phase_3
157 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 24, 2007
CompletedFirst Posted
Study publicly available on registry
August 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
April 23, 2014
CompletedJuly 19, 2018
July 1, 2017
5.3 years
August 24, 2007
November 26, 2013
June 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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: 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
16 Weeks Maintenance Period (approximately 112 days)
Secondary Outcomes (5)
Time to First Occurrence of Any Exit Event During The Maintenance Period
16 Weeks Maintenance Period (approximately 112 days)
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
16 Weeks Maintenance Period (approximately 112 days)
Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)
Visit 9 - Visit 12 (approximately 10 weeks)
Clinical Global Impression of Change (CGIC) From Baseline To Last Visit
Baseline; Last Visit (approximately 27 weeks)
Patient's Global Impression of Change (PGIC) From Baseline To Last Visit
Baseline; Last Visit (approximately 27 weeks)
Study Arms (2)
Lacosamide 400 mg/day
EXPERIMENTALLacosamide 400 mg/day
Lacosamide 300 mg/day
ACTIVE COMPARATORLacosamide 300 mg/day
Interventions
50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (158)
48
Alabaster, Alabama, United States
10
Birmingham, Alabama, United States
18
Huntsville, Alabama, United States
42
Northport, Alabama, United States
14
Phoenix, Arizona, United States
151
Phoenix, Arizona, United States
9
Phoenix, Arizona, United States
150
Sun City, Arizona, United States
103
Tucson, Arizona, United States
102
Jonesboro, Arkansas, United States
7
Little Rock, Arkansas, United States
86
Little Rock, Arkansas, United States
120
La Habra, California, United States
156
Loma Linda, California, United States
59
Los Angeles, California, United States
76
Los Angeles, California, United States
45
Newport Beach, California, United States
21
Santa Monica, California, United States
107
Torrance, California, United States
60
Aurora, Colorado, United States
25
Fairfield, Connecticut, United States
133
Dover, Delaware, United States
37
Washington D.C., District of Columbia, United States
94
Doral, Florida, United States
108
Gainesville, Florida, United States
130
Gulf Breeze, Florida, United States
55
Maitland, Florida, United States
123
Miami, Florida, United States
132
Miami, Florida, United States
77
Orlando, Florida, United States
49
Panama City, Florida, United States
109
Pinellas Park, Florida, United States
129
Port Charlotte, Florida, United States
50
Sarasota, Florida, United States
81
Sarasota, Florida, United States
4
Tallahassee, Florida, United States
163
Tampa, Florida, United States
79
Atlanta, Georgia, United States
72
Canton, Georgia, United States
40
Savannah, Georgia, United States
58
Boise, Idaho, United States
131
Hines, Illinois, United States
146
Peoria, Illinois, United States
11
Springfield, Illinois, United States
78
Indianapolis, Indiana, United States
73
Ames, Iowa, United States
124
Manhattan, Kansas, United States
160
Wichita, Kansas, United States
23
Wichita, Kansas, United States
119
Lexington, Kentucky, United States
164
Lexington, Kentucky, United States
62
Louisville, Kentucky, United States
29
Scarborough, Maine, United States
20
Baltimore, Maryland, United States
34
Baltimore, Maryland, United States
19
Bethesda, Maryland, United States
65
Pikesville, Maryland, United States
137
Waldorf, Maryland, United States
41
Detroit, Michigan, United States
30
Golden Valley, Minnesota, United States
71
Hattiesburg, Mississippi, United States
31
Chesterfield, Missouri, United States
105
Columbia, Missouri, United States
66
St Louis, Missouri, United States
174
Omaha, Nebraska, United States
17
Lebanon, New Hampshire, United States
43
Edison, New Jersey, United States
67
Voorhees Township, New Jersey, United States
36
Albany, New York, United States
83
Buffalo, New York, United States
69
Cedarhurst, New York, United States
154
Mineola, New York, United States
122
New York, New York, United States
27
New York, New York, United States
175
Schenectady, New York, United States
3
Asheville, North Carolina, United States
63
Durham, North Carolina, United States
152
Rocky Mount, North Carolina, United States
117
Wilmington, North Carolina, United States
47
Winston-Salem, North Carolina, United States
15
Cleveland, Ohio, United States
61
Columbus, Ohio, United States
2
Toledo, Ohio, United States
147
Oklahoma City, Oklahoma, United States
8
Medford, Oregon, United States
157
Portland, Oregon, United States
100
Greensburg, Pennsylvania, United States
32
Philadelphia, Pennsylvania, United States
26
Tarentum, Pennsylvania, United States
24
Beaufort, South Carolina, United States
114
Chattanooga, Tennessee, United States
1
Nashville, Tennessee, United States
138
Austin, Texas, United States
111
Dallas, Texas, United States
22
Dallas, Texas, United States
46
El Paso, Texas, United States
51
Houston, Texas, United States
53
Houston, Texas, United States
98
San Antonio, Texas, United States
82
Temple, Texas, United States
136
Layton, Utah, United States
161
Alexandria, Virginia, United States
16
Charlottesville, Virginia, United States
106
Richmond, Virginia, United States
125
Winchester, Virginia, United States
74
Renton, Washington, United States
80
Madison, Wisconsin, United States
28
Milwaukee, Wisconsin, United States
421
Capmerdown, New South Wales, Australia
425
Chatswood, New South Wales, Australia
423
Herston, Queensland, Australia
422
Maroochydore, Queensland, Australia
420
Adelaide, South Australia, Australia
429
Clayton, Victoria, Australia
427
Parkville, Victoria, Australia
204
Innsbruck, Austria
127
Calgary, Alberta, Canada
140
Halifax, Nova Scotia, Canada
116
Hamilton, Ontario, Canada
93
London, Ontario, Canada
91
Greenfield Park, Quebec, Canada
110
Montreal, Quebec, Canada
113
Montreal, Quebec, Canada
223
Aarhus, Denmark
220
Copenhagen, Denmark
402
Bron, France
404
Dijon, France
405
Ramonville-Saint-Agne, France
465
Berlin, Germany
461
Mainz, Germany
240
Dublin, Ireland
442
Bologna, Italy
449
Catanzaro, Italy
443
Ferrara, Italy
441
Milan, Italy
450
Perugia, Italy
448
Pisa, Italy
445
Reggio Calabria, Italy
447
Torrette Di Ancona, Italy
284
Częstochowa, Poland
286
Gdansk, Poland
282
Gdynia, Poland
280
Krakow, Poland
283
Lublin, Poland
290
Lublin, Poland
289
Szczecin, Poland
281
Warsaw, Poland
287
Warsaw, Poland
158
San Juan, Puerto Rico
323
Granada, Spain
324
Santa Cruz de Tenerife, Spain
360
Blackpool, United Kingdom
364
London, United Kingdom
369
London, United Kingdom
361
Manchester, United Kingdom
363
Middlesbrough, United Kingdom
368
Stoke-on-Trent, United Kingdom
367
Truro, United Kingdom
Related Publications (1)
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.
PMID: 24915838DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
August 24, 2007
First Posted
August 27, 2007
Study Start
August 1, 2007
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
July 19, 2018
Results First Posted
April 23, 2014
Record last verified: 2017-07