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

NCT ID: NCT00520741

Last Updated: 2018-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 426 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2012-12-31

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the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.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increased risk of SUDEP in patients with only GTCS in a trial setting, the 1 remaining patient with only GTCS was withdrawn from this study.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Lacosamide 400 mg/day

Lacosamide 400 mg/day

Group Type: EXPERIMENTAL

Lacosamide

Intervention Type: DRUG

50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.

Lacosamide 300 mg/day

Lacosamide 300 mg/day

Group Type: ACTIVE_COMPARATOR

Lacosamide

Intervention Type: DRUG

50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.

Interventions

Lacosamide

50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.

Intervention Type: DRUG

Lacosamide

50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.

Intervention Type: DRUG

Other Intervention Names

Vimpat; Vimpat

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB BIOSCIENCES, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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

Countries

United States; Australia; Austria; Canada; Denmark; France; Germany; Ireland; Italy; Poland; Puerto Rico; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 24915838 (View on PubMed)

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA safety Alerts and Recalls

Other Identifiers

2007-005439-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP0902

Identifier Type: -

Identifier Source: org_study_id

NCT01058954

Identifier Type: -

Identifier Source: nct_alias