Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures

Epilepsy Clinical Trial

Official title:

A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects With Partial-onset Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530855
• Other study ID #: SP0904
• Secondary ID: 2007-005440-25
• Status: Completed
• Phase: Phase 3
• Start date: February 2008
• Est. completion date: December 2014

Study information

• Verified date: July 2017
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This open-label extension trial will assess the long-term use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

• Subject has entered the Maintenance Phase of the double-blind trial, SP902, (ie, has taken at least 1 dose of SP902 Maintenance Phase trial medication) and either completed SP902 or met an exit criterion in SP902; subject is allowed up to 2 concomitant Antiepileptic Drugs (AEDs)

Exclusion Criteria:

• Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial, or is experiencing an ongoing Serious Adverse Event (SAE)

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Drug:
• Lacosamide
50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years

Locations

Country	Name	City	State
Australia	420	Adelaide	South Australia
Australia	421	Capmerdown	New South Wales
Australia	425	Chatswood	New South Wales
Australia	423	Herston	Queensland
Australia	427	Parkville	Victoria
Canada	127	Calgary
Canada	091	Greenfield Park	Quebec
Canada	140	Halifax	Nova Scotia
Canada	116	Hamilton	Ontario
Canada	093	London	Ontario
Canada	110	Montreal	Quebec
Canada	113	Montreal	Quebec
Denmark	223	Aarhus
Germany	461	Mainz
Italy	443	Ferrara
Italy	445	Reggio Calabria
Italy	447	Torrette Di Ancona
Poland	284	Czestochowa
Poland	286	Gdansk
Poland	282	Gdynia
Poland	280	Krakow
Poland	290	Lublin
Poland	289	Szczecin
Poland	281	Warszawa
Poland	287	Warszawa
Spain	324	Santa Cruz de Tenerife
United Kingdom	360	Blackpool
United Kingdom	367	Cornwall
United Kingdom	364	London
United Kingdom	369	London
United Kingdom	363	Middlesborough
United States	048	Alabaster	Alabama
United States	036	Albany	New York
United States	161	Alexandria	Virginia
United States	073	Ames	Iowa
United States	003	Asheville	North Carolina
United States	079	Atlanta	Georgia
United States	060	Aurora	Colorado
United States	138	Austin	Texas
United States	020	Baltimore	Maryland
United States	034	Baltimore	Maryland
United States	024	Beaufort	South Carolina
United States	010	Birmingham	Alabama
United States	058	Boise	Idaho
United States	083	Buffalo	New York
United States	069	Cedarhurst	New York
United States	016	Charlottesville	Virginia
United States	114	Chattanooga	Tennessee
United States	031	Chesterfield	Missouri
United States	015	Cleveland	Ohio
United States	061	Columbus	Ohio
United States	022	Dallas	Texas
United States	041	Detroit	Michigan
United States	094	Doral	Florida
United States	063	Durham	North Carolina
United States	046	El Paso	Texas
United States	025	Fairfield	Connecticut
United States	108	Gainesville	Florida
United States	030	Golden Valley	Minnesota
United States	100	Greensburg	Pennsylvania
United States	071	Hattiesburg	Mississippi
United States	131	Hines	Illinois
United States	051	Houston	Texas
United States	053	Houston	Texas
United States	078	Indianapolis	Indiana
United States	102	Jonesboro	Arkansas
United States	120	La Habra	California
United States	136	Layton	Utah
United States	017	Lebanon	New Hampshire
United States	164	Lexington	Kentucky
United States	007	Little Rock	Arkansas
United States	086	Little Rock	Arkansas
United States	059	Los Angeles	California
United States	062	Louisville	Kentucky
United States	080	Madison	Wisconsin
United States	124	Manhattan	Kansas
United States	123	Miami	Florida
United States	132	Miami	Florida
United States	001	Nashville	Tennessee
United States	027	New York	New York
United States	122	New York	New York
United States	042	Northport	Alabama
United States	147	Oklahoma City	Oklahoma
United States	077	Orlando	Florida
United States	049	Panama City	Florida
United States	146	Peoria	Illinois
United States	032	Philadelphia	Pennsylvania
United States	009	Phoenix	Arizona
United States	014	Phoenix	Arizona
United States	151	Phoenix	Arizona
United States	065	Pikesville	Maryland
United States	129	Port Charlotte	Florida
United States	074	Renton	Washington
United States	066	Saint Louis	Missouri
United States	098	San Antonio	Texas
United States	021	Santa Monica	California
United States	050	Sarasota	Florida
United States	029	Scarborough	Maine
United States	011	Springfield	Illinois
United States	004	Tallahassee	Florida
United States	002	Toledo	Ohio
United States	107	Torrance	California
United States	103	Tucson	Arizona
United States	067	Voorhees	New Jersey
United States	137	Waldorf	Maryland
United States	023	Wichita	Kansas
United States	160	Wichita	Kansas
United States	117	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Denmark,  Germany,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study	Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.	From Visit 1 to End of Study (approximately 2 years)
Primary	Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study	Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.	From Visit 1 to End of Study (approximately 2 years)
Secondary	Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study	A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.; An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).	From Visit 1 to End of Study (approximately 2 years)
Secondary	Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study		From Visit 1 to End of Study (approximately 2 years)

External Links

•   FDA Safety Alerts and Recalls
•   Product Information