Trial record 1 of 1 for:    NCT00520741
Previous Study | Return to List | Next Study

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00520741
First received: August 24, 2007
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.


Condition Intervention Phase
Epilepsy
Drug: Lacosamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

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) [ Time Frame: 16 Weeks Maintenance Period (approximately 112 days) ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Time to First Occurrence of Any Exit Event During The Maintenance Period [ Time Frame: 16 Weeks Maintenance Period (approximately 112 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 16 Weeks Maintenance Period (approximately 112 days) ] [ Designated as safety issue: No ]

    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.


  • 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline; Last Visit (approximately 27 weeks) ] [ Designated as safety issue: No ]

    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

  • Patient's Global Impression of Change (PGIC) From Baseline To Last Visit [ Time Frame: Baseline; Last Visit (approximately 27 weeks) ] [ Designated as safety issue: No ]

    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


Enrollment: 426
Study Start Date: August 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacosamide 400 mg/day
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 Name: Vimpat
Active Comparator: Lacosamide 300 mg/day
Lacosamide 300 mg/day
Drug: Lacosamide
50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.
Other Name: Vimpat

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.

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520741

  Hide Study Locations
Locations
United States, Alabama
48
Alabaster, Alabama, United States
10
Birmingham, Alabama, United States
18
Huntsville, Alabama, United States
42
Northport, Alabama, United States
United States, Arizona
9
Phoenix, Arizona, United States
14
Phoenix, Arizona, United States
151
Phoenix, Arizona, United States
150
Sun City, Arizona, United States
103
Tucson, Arizona, United States
United States, Arkansas
102
Jonesboro, Arkansas, United States
7
Little Rock, Arkansas, United States
86
Little Rock, Arkansas, United States
United States, California
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
United States, Colorado
60
Aurora, Colorado, United States
United States, Connecticut
25
Fairfield, Connecticut, United States
United States, Delaware
133
Dover, Delaware, United States
United States, District of Columbia
37
Washington, District of Columbia, United States
United States, Florida
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
United States, Georgia
79
Atlanta, Georgia, United States
72
Canton, Georgia, United States
40
Savannah, Georgia, United States
United States, Idaho
58
Boise, Idaho, United States
United States, Illinois
131
Hines, Illinois, United States
146
Peoria, Illinois, United States
11
Springfield, Illinois, United States
United States, Indiana
78
Indianapolis, Indiana, United States
United States, Iowa
73
Ames, Iowa, United States
United States, Kansas
124
Manhattan, Kansas, United States
23
Wichita, Kansas, United States
160
Wichita, Kansas, United States
United States, Kentucky
119
Lexington, Kentucky, United States
164
Lexington, Kentucky, United States
62
Louisville, Kentucky, United States
United States, Maine
29
Scarborough, Maine, United States
United States, Maryland
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
United States, Michigan
41
Detroit, Michigan, United States
United States, Minnesota
30
Golden Valley, Minnesota, United States
United States, Mississippi
71
Hattiesburg, Mississippi, United States
United States, Missouri
31
Chesterfield, Missouri, United States
105
Columbia, Missouri, United States
66
St Louis, Missouri, United States
United States, Nebraska
174
Omaha, Nebraska, United States
United States, New Hampshire
17
Lebanon, New Hampshire, United States
United States, New Jersey
43
Edison, New Jersey, United States
67
Voorhees, New Jersey, United States
United States, New York
36
Albany, New York, United States
83
Buffalo, New York, United States
69
Cedarhurst, New York, United States
154
Mineola, New York, United States
27
New York, New York, United States
122
New York, New York, United States
175
Schenectady, New York, United States
United States, North Carolina
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
United States, Ohio
15
Cleveland, Ohio, United States
61
Columbus, Ohio, United States
2
Toledo, Ohio, United States
United States, Oklahoma
147
Oklahoma City, Oklahoma, United States
United States, Oregon
8
Medford, Oregon, United States
157
Portland, Oregon, United States
United States, Pennsylvania
100
Greensburg, Pennsylvania, United States
32
Philadelphia, Pennsylvania, United States
26
Tarentum, Pennsylvania, United States
United States, South Carolina
24
Beaufort, South Carolina, United States
United States, Tennessee
114
Chattanooga, Tennessee, United States
1
Nashville, Tennessee, United States
United States, Texas
138
Austin, Texas, United States
22
Dallas, Texas, United States
111
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
United States, Utah
136
Layton, Utah, United States
United States, Virginia
161
Alexandria, Virginia, United States
16
Charlottesville, Virginia, United States
106
Richmond, Virginia, United States
125
Winchester, Virginia, United States
United States, Washington
74
Renton, Washington, United States
United States, Wisconsin
80
Madison, Wisconsin, United States
28
Milwaukee, Wisconsin, United States
Australia, New South Wales
421
Capmerdown, New South Wales, Australia
425
Chatswood, New South Wales, Australia
Australia, Queensland
423
Herston, Queensland, Australia
422
Maroochydore, Queensland, Australia
Australia, South Australia
420
Adelaide, South Australia, Australia
Australia, Victoria
429
Clayton, Victoria, Australia
427
Parkville, Victoria, Australia
Austria
204
Innsbruck, Austria
Canada, Alberta
127
Calgary, Alberta, Canada
Canada, Nova Scotia
140
Halifax, Nova Scotia, Canada
Canada, Ontario
116
Hamilton, Ontario, Canada
93
London, Ontario, Canada
Canada, Quebec
91
Greenfield Park, Quebec, Canada
110
Montreal, Quebec, Canada
113
Montreal, Quebec, Canada
Denmark
223
Aarhus, Denmark
220
Copenhagen, Denmark
France
402
Bron, France
404
Dijon, France
405
Ramonville Saint Agne, France
Germany
465
Berlin, Germany
461
Mainz, Germany
Ireland
240
Dublin, Ireland
Italy
442
Bologna, Italy
449
Catanzaro, Italy
443
Ferrara, Italy
441
Milano, Italy
450
Perugia, Italy
448
Pisa, Italy
445
Reggio Calabria, Italy
447
Torrette Di Ancona, Italy
Poland
284
Czestochowa, Poland
286
Gdansk, Poland
282
Gdynia, Poland
280
Krakow, Poland
283
Lublin, Poland
290
Lublin, Poland
289
Szczecin, Poland
281
Warszawa, Poland
287
Warszawa, Poland
Puerto Rico
158
San Juan, Puerto Rico
Spain
323
Granada, Spain
324
Santa Cruz De Tenerife, Spain
United Kingdom
360
Blackpool, United Kingdom
364
London, United Kingdom
369
London, United Kingdom
361
Manchester, United Kingdom
363
Middlesborough, United Kingdom
368
Stoke on Trent, United Kingdom
367
Truro, United Kingdom
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00520741     History of Changes
Obsolete Identifiers: NCT01058954
Other Study ID Numbers: SP902
Study First Received: August 24, 2007
Results First Received: November 26, 2013
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Spanish Agency of Medicines
Denmark: Danish Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
Italy: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB, Inc.:
Epilepsy
Partial Onset Seizures
Lacosamide
Monotherapy
Vimpat

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 08, 2014