EpilepsyPhase 3ALEX-MTNCT00520741
Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures
A Phase 3 study testing Lacosamide in people with Epilepsy, run by UCB BIOSCIENCES, Inc. at 158 sites in 13 countries.
Trial 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the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Lacosamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 158 sitesin 13 countries
- Study dates
- Aug 2007to Dec 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
158 sites in 13 countries.
158 sites in 13 countries
United States108 sites
48
Alabaster, Alabama
36
Albany, New York
161
Alexandria, Virginia
73
Ames, Iowa
3
Asheville, North Carolina
79
Atlanta, Georgia
60
Aurora, Colorado
138
Austin, Texas
20
Baltimore, Maryland
34
Baltimore, Maryland
24
Beaufort, South Carolina
19
Bethesda, Maryland
10
Birmingham, Alabama
58
Boise, Idaho
83
Buffalo, New York
72
Canton, Georgia
69
Cedarhurst, New York
16
Charlottesville, Virginia
114
Chattanooga, Tennessee
31
Chesterfield, Missouri
15
Cleveland, Ohio
105
Columbia, Missouri
61
Columbus, Ohio
111
Dallas, Texas
22
Dallas, Texas
41
Detroit, Michigan
94
Doral, Florida
133
Dover, Delaware
63
Durham, North Carolina
43
Edison, New Jersey
46
El Paso, Texas
25
Fairfield, Connecticut
108
Gainesville, Florida
30
Golden Valley, Minnesota
100
Greensburg, Pennsylvania
130
Gulf Breeze, Florida
71
Hattiesburg, Mississippi
131
Hines, Illinois
51
Houston, Texas
53
Houston, Texas
18
Huntsville, Alabama
78
Indianapolis, Indiana
102
Jonesboro, Arkansas
120
La Habra, California
136
Layton, Utah
17
Lebanon, New Hampshire
119
Lexington, Kentucky
164
Lexington, Kentucky
7
Little Rock, Arkansas
86
Little Rock, Arkansas
156
Loma Linda, California
59
Los Angeles, California
76
Los Angeles, California
62
Louisville, Kentucky
80
Madison, Wisconsin
55
Maitland, Florida
124
Manhattan, Kansas
8
Medford, Oregon
123
Miami, Florida
132
Miami, Florida
28
Milwaukee, Wisconsin
154
Mineola, New York
1
Nashville, Tennessee
122
New York, New York
27
New York, New York
45
Newport Beach, California
42
Northport, Alabama
147
Oklahoma City, Oklahoma
174
Omaha, Nebraska
77
Orlando, Florida
49
Panama City, Florida
146
Peoria, Illinois
32
Philadelphia, Pennsylvania
14
Phoenix, Arizona
151
Phoenix, Arizona
9
Phoenix, Arizona
65
Pikesville, Maryland
109
Pinellas Park, Florida
129
Port Charlotte, Florida
157
Portland, Oregon
74
Renton, Washington
106
Richmond, Virginia
152
Rocky Mount, North Carolina
98
San Antonio, Texas
21
Santa Monica, California
50
Sarasota, Florida
81
Sarasota, Florida
40
Savannah, Georgia
29
Scarborough, Maine
175
Schenectady, New York
11
Springfield, Illinois
66
St Louis, Missouri
150
Sun City, Arizona
4
Tallahassee, Florida
163
Tampa, Florida
26
Tarentum, Pennsylvania
82
Temple, Texas
2
Toledo, Ohio
107
Torrance, California
103
Tucson, Arizona
67
Voorhees Township, New Jersey
137
Waldorf, Maryland
37
Washington D.C., District of Columbia
160
Wichita, Kansas
23
Wichita, Kansas
117
Wilmington, North Carolina
125
Winchester, Virginia
47
Winston-Salem, North Carolina
Poland9 sites
284
Częstochowa
286
Gdansk
282
Gdynia
280
Krakow
283
Lublin
290
Lublin
289
Szczecin
281
Warsaw
287
Warsaw
Italy8 sites
442
Bologna
449
Catanzaro
443
Ferrara
441
Milan
450
Perugia
448
Pisa
445
Reggio Calabria
447
Torrette Di Ancona
Australia7 sites
420
Adelaide, South Australia
421
Capmerdown, New South Wales
425
Chatswood, New South Wales
429
Clayton, Victoria
423
Herston, Queensland
422
Maroochydore, Queensland
427
Parkville, Victoria
Canada7 sites
127
Calgary, Alberta
91
Greenfield Park, Quebec
140
Halifax, Nova Scotia
116
Hamilton, Ontario
93
London, Ontario
110
Montreal, Quebec
113
Montreal, Quebec
United Kingdom7 sites
360
Blackpool
364
London
369
London
361
Manchester
363
Middlesbrough
368
Stoke-on-Trent
367
Truro
About this study
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
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Lacosamide
- Keywords
- Epilepsy, Partial Onset Seizures, Lacosamide, Monotherapy, Vimpat
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacosamideDrug
Also called Vimpat
50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
LacosamideDrug
Also called Vimpat
50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide 400 mg/day | Experimental | Lacosamide 400 mg/day Receives: Drug: Lacosamide |
| Lacosamide 300 mg/day | Active comparator | Lacosamide 300 mg/day Receives: Drug: Lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 Weeks Maintenance Period (approximately 112 days)
Secondary outcomes (5)
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.
Measured: 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
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.
Measured: 16 Weeks Maintenance Period (approximately 112 days)
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.
Measured: Visit 9 - Visit 12 (approximately 10 weeks)
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
Measured: Baseline; Last Visit (approximately 27 weeks)
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
Measured: Baseline; Last Visit (approximately 27 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520741
- Sponsor's protocol ID
- SP0902
- Other IDs
- 2007-005439-27
- Acronym
- ALEX-MT
- Status last verified
- Jul 2017
- First submitted
- 24 Aug 2007
- Last updated
- 19 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Expanded access
- Available
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.
PubMed 24915838
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00520741
- Acronym / sponsor ID
- ALEX-MT / SP0902
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Partial Onset Seizures, Lacosamide, Monotherapy, Vimpat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Aug 2007 (estimated)
- Results
- Posted 23 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lacosamide 400 mg/day | Experimental | Drug: LacosamideLacosamide 400 mg/day |
| Lacosamide 300 mg/day | Active comparator | Drug: LacosamideLacosamide 300 mg/day |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LacosamideAlso: Vimpat50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. | Drug | Lacosamide 400 mg/day |
| LacosamideAlso: Vimpat50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. | Drug | Lacosamide 300 mg/day |
Primary outcome
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)
Time frame: 16 Weeks Maintenance Period (approximately 112 days)
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
5 secondary outcomes
Time to First Occurrence of Any Exit Event During The Maintenance Period
Time frame: 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
Time frame: 16 Weeks Maintenance Period (approximately 112 days)
Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)
Time frame: Visit 9 - Visit 12 (approximately 10 weeks)
Clinical Global Impression of Change (CGIC) From Baseline To Last Visit
Time frame: Baseline; Last Visit (approximately 27 weeks)
Patient's Global Impression of Change (PGIC) From Baseline To Last Visit
Time frame: Baseline; Last Visit (approximately 27 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24915838Wechsler 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.
- FDA safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
158 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lacosamide in people with Epilepsy, run by UCB BIOSCIENCES, Inc. at 158 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 158 sites in United States, Poland, Italy, Australia, Canada and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 16 Weeks Maintenance Period (approximately 112 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00520741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.