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

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Lacosamide (Drug); Lacosamide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: UCB BIOSCIENCES, Inc.

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)

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the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.

Clinical Details

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

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

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)

Secondary outcome:

Time to First Occurrence of Any Exit Event During The Maintenance Period

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

Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)

Clinical Global Impression of Change (CGIC) From Baseline To Last Visit

Patient's Global Impression of Change (PGIC) From Baseline To Last Visit

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

Minimum age: 16 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

204, Innsbruck, Austria

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, Milano, Italy

450, Perugia, Italy

448, Pisa, Italy

445, Reggio Calabria, Italy

447, Torrette Di Ancona, Italy

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

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, Middlesborough, United Kingdom

368, Stoke on Trent, United Kingdom

367, Truro, United Kingdom

48, Alabaster, Alabama, United States

10, Birmingham, Alabama, United States

18, Huntsville, Alabama, United States

42, Northport, Alabama, United States

127, Calgary, Alberta, Canada

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, 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, New Jersey, United States

421, Capmerdown, New South Wales, Australia

425, Chatswood, New South Wales, Australia

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

140, Halifax, Nova Scotia, Canada

15, Cleveland, Ohio, United States

61, Columbus, Ohio, United States

2, Toledo, Ohio, United States

147, Oklahoma City, Oklahoma, United States

116, Hamilton, Ontario, Canada

93, London, Ontario, Canada

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

91, Greenfield Park, Quebec, Canada

110, Montreal, Quebec, Canada

113, Montreal, Quebec, Canada

423, Herston, Queensland, Australia

422, Maroochydore, Queensland, Australia

420, Adelaide, South Australia, Australia

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

429, Clayton, Victoria, Australia

427, Parkville, Victoria, Australia

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

Additional Information

Product information

FDA safety Alerts and Recalls

Starting date: August 2007
Last updated: July 13, 2015

Page last updated: August 23, 2015

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