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

June 20, 2018 updated by: UCB BIOSCIENCES, Inc.

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the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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increased risk of SUDEP in patients with only GTCS in a trial setting, the 1 remaining patient with only GTCS was withdrawn from this study.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 Type

Interventional

Enrollment (Actual)

426

Phase

  • Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Capmerdown, New South Wales, Australia
        • 421
      • Chatswood, New South Wales, Australia
        • 425
    • Queensland
      • Herston, Queensland, Australia
        • 423
      • Maroochydore, Queensland, Australia
        • 422
    • South Australia
      • Adelaide, South Australia, Australia
        • 420
    • Victoria
      • Clayton, Victoria, Australia
        • 429
      • Parkville, Victoria, Australia
        • 427
  • Austria
      • Innsbruck, Austria
        • 204
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • 127
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • 140
    • Ontario
      • Hamilton, Ontario, Canada
        • 116
      • London, Ontario, Canada
        • 93
    • Quebec
      • Greenfield Park, Quebec, Canada
        • 91
      • Montreal, Quebec, Canada
        • 110
      • Montreal, Quebec, Canada
        • 113
  • Denmark
      • Aarhus, Denmark
        • 223
      • Copenhagen, Denmark
        • 220
  • France
      • Bron, France
        • 402
      • Dijon, France
        • 404
      • Ramonville Saint Agne, France
        • 405
  • Germany
      • Berlin, Germany
        • 465
      • Mainz, Germany
        • 461
  • Ireland
      • Dublin, Ireland
        • 240
  • Italy
      • Bologna, Italy
        • 442
      • Catanzaro, Italy
        • 449
      • Ferrara, Italy
        • 443
      • Milano, Italy
        • 441
      • Perugia, Italy
        • 450
      • Pisa, Italy
        • 448
      • Reggio Calabria, Italy
        • 445
      • Torrette Di Ancona, Italy
        • 447
  • Poland
      • Czestochowa, Poland
        • 284
      • Gdansk, Poland
        • 286
      • Gdynia, Poland
        • 282
      • Krakow, Poland
        • 280
      • Lublin, Poland
        • 283
      • Lublin, Poland
        • 290
      • Szczecin, Poland
        • 289
      • Warszawa, Poland
        • 281
      • Warszawa, Poland
        • 287
  • Puerto Rico
      • San Juan, Puerto Rico
        • 158
  • Spain
      • Granada, Spain
        • 323
      • Santa Cruz De Tenerife, Spain
        • 324
  • United Kingdom
      • Blackpool, United Kingdom
        • 360
      • London, United Kingdom
        • 364
      • London, United Kingdom
        • 369
      • Manchester, United Kingdom
        • 361
      • Middlesborough, United Kingdom
        • 363
      • Stoke on Trent, United Kingdom
        • 368
      • Truro, United Kingdom
        • 367
  • United States
    • Alabama
      • Alabaster, Alabama, United States
        • 48
      • Birmingham, Alabama, United States
        • 10
      • Huntsville, Alabama, United States
        • 18
      • Northport, Alabama, United States
        • 42
    • Arizona
      • Phoenix, Arizona, United States
        • 14
      • Phoenix, Arizona, United States
        • 151
      • Phoenix, Arizona, United States
        • 9
      • Sun City, Arizona, United States
        • 150
      • Tucson, Arizona, United States
        • 103
    • Arkansas
      • Jonesboro, Arkansas, United States
        • 102
      • Little Rock, Arkansas, United States
        • 7
      • Little Rock, Arkansas, United States
        • 86
    • California
      • La Habra, California, United States
        • 120
      • Loma Linda, California, United States
        • 156
      • Los Angeles, California, United States
        • 59
      • Los Angeles, California, United States
        • 76
      • Newport Beach, California, United States
        • 45
      • Santa Monica, California, United States
        • 21
      • Torrance, California, United States
        • 107
    • Colorado
      • Aurora, Colorado, United States
        • 60
    • Connecticut
      • Fairfield, Connecticut, United States
        • 25
    • Delaware
      • Dover, Delaware, United States
        • 133
    • District of Columbia
      • Washington, District of Columbia, United States
        • 37
    • Florida
      • Doral, Florida, United States
        • 94
      • Gainesville, Florida, United States
        • 108
      • Gulf Breeze, Florida, United States
        • 130
      • Maitland, Florida, United States
        • 55
      • Miami, Florida, United States
        • 123
      • Miami, Florida, United States
        • 132
      • Orlando, Florida, United States
        • 77
      • Panama City, Florida, United States
        • 49
      • Pinellas Park, Florida, United States
        • 109
      • Port Charlotte, Florida, United States
        • 129
      • Sarasota, Florida, United States
        • 50
      • Sarasota, Florida, United States
        • 81
      • Tallahassee, Florida, United States
        • 4
      • Tampa, Florida, United States
        • 163
    • Georgia
      • Atlanta, Georgia, United States
        • 79
      • Canton, Georgia, United States
        • 72
      • Savannah, Georgia, United States
        • 40
    • Idaho
      • Boise, Idaho, United States
        • 58
    • Illinois
      • Hines, Illinois, United States
        • 131
      • Peoria, Illinois, United States
        • 146
      • Springfield, Illinois, United States
        • 11
    • Indiana
      • Indianapolis, Indiana, United States
        • 78
    • Iowa
      • Ames, Iowa, United States
        • 73
    • Kansas
      • Manhattan, Kansas, United States
        • 124
      • Wichita, Kansas, United States
        • 160
      • Wichita, Kansas, United States
        • 23
    • Kentucky
      • Lexington, Kentucky, United States
        • 119
      • Lexington, Kentucky, United States
        • 164
      • Louisville, Kentucky, United States
        • 62
    • Maine
      • Scarborough, Maine, United States
        • 29
    • Maryland
      • Baltimore, Maryland, United States
        • 20
      • Baltimore, Maryland, United States
        • 34
      • Bethesda, Maryland, United States
        • 19
      • Pikesville, Maryland, United States
        • 65
      • Waldorf, Maryland, United States
        • 137
    • Michigan
      • Detroit, Michigan, United States
        • 41
    • Minnesota
      • Golden Valley, Minnesota, United States
        • 30
    • Mississippi
      • Hattiesburg, Mississippi, United States
        • 71
    • Missouri
      • Chesterfield, Missouri, United States
        • 31
      • Columbia, Missouri, United States
        • 105
      • Saint Louis, Missouri, United States
        • 66
    • Nebraska
      • Omaha, Nebraska, United States
        • 174
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • 17
    • New Jersey
      • Edison, New Jersey, United States
        • 43
      • Voorhees, New Jersey, United States
        • 67
    • New York
      • Albany, New York, United States
        • 36
      • Buffalo, New York, United States
        • 83
      • Cedarhurst, New York, United States
        • 69
      • Mineola, New York, United States
        • 154
      • New York, New York, United States
        • 122
      • New York, New York, United States
        • 27
      • Schenectady, New York, United States
        • 175
    • North Carolina
      • Asheville, North Carolina, United States
        • 3
      • Durham, North Carolina, United States
        • 63
      • Rocky Mount, North Carolina, United States
        • 152
      • Wilmington, North Carolina, United States
        • 117
      • Winston-Salem, North Carolina, United States
        • 47
    • Ohio
      • Cleveland, Ohio, United States
        • 15
      • Columbus, Ohio, United States
        • 61
      • Toledo, Ohio, United States
        • 2
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 147
    • Oregon
      • Medford, Oregon, United States
        • 8
      • Portland, Oregon, United States
        • 157
    • Pennsylvania
      • Greensburg, Pennsylvania, United States
        • 100
      • Philadelphia, Pennsylvania, United States
        • 32
      • Tarentum, Pennsylvania, United States
        • 26
    • South Carolina
      • Beaufort, South Carolina, United States
        • 24
    • Tennessee
      • Chattanooga, Tennessee, United States
        • 114
      • Nashville, Tennessee, United States
        • 1
    • Texas
      • Austin, Texas, United States
        • 138
      • Dallas, Texas, United States
        • 111
      • Dallas, Texas, United States
        • 22
      • El Paso, Texas, United States
        • 46
      • Houston, Texas, United States
        • 51
      • Houston, Texas, United States
        • 53
      • San Antonio, Texas, United States
        • 98
      • Temple, Texas, United States
        • 82
    • Utah
      • Layton, Utah, United States
        • 136
    • Virginia
      • Alexandria, Virginia, United States
        • 161
      • Charlottesville, Virginia, United States
        • 16
      • Richmond, Virginia, United States
        • 106
      • Winchester, Virginia, United States
        • 125
    • Washington
      • Renton, Washington, United States
        • 74
    • Wisconsin
      • Madison, Wisconsin, United States
        • 80
      • Milwaukee, Wisconsin, United States
        • 28

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lacosamide 400 mg/day
Drug: Lacosamide
50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
Other Names:
  • Vimpat
Drug: Lacosamide
50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
Other Names:
  • Vimpat
ACTIVE_COMPARATOR: Lacosamide 300 mg/day
Drug: Lacosamide
50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.
Other Names:
  • Vimpat
Drug: Lacosamide
50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
Other Names:
  • Vimpat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
16 Weeks Maintenance Period (approximately 112 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Occurrence of Any Exit Event During The Maintenance Period
Time Frame: 16 Weeks Maintenance Period (approximately 112 days)
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.
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)

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.
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)
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.
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)

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
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)

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
Baseline; Last Visit (approximately 27 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB BIOSCIENCES, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

August 24, 2007

First Submitted That Met QC Criteria

August 24, 2007

First Posted (ESTIMATE)

August 27, 2007

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2018

Last Update Submitted That Met QC Criteria

June 20, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0902
  • 2007-005439-27 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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