Clinical trial NCT00552305: To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
Official title: An Open-label Extension Trial to Determine Tolerability and Efficacy of Long-term Oral SPM 927 as Adjunctive Therapy in Patients With Partial Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Partial Epilepsies
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-11-01
Enrollment: 370
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy.


Eligibility criteria: Inclusion Criteria:

* Completion of parent clinical trial for treatment of partial seizures.

Exclusion Criteria:

* Receiving any study drug or experimental device other than lacosamide.
* Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event.

Primary outcomes:
measure: Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)
timeFrame: During the Treatment Period (up to 8 years)
measure: Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)
timeFrame: During the Treatment Period (up to 8 years)
measure: Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years)
timeFrame: During the Treatment Period (up to 8 years)
Secondary outcomes:
measure: Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years)
timeFrame: Baseline, End of Treatment Period (up to 8 years)
measure: Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years)
timeFrame: Treatment Period (up to 8 years)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Englewood
country: United States
state: Colorado
city: Gainesville
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Ponte Vedra Beach
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Wichita
country: United States
state: Kansas
city: Crestview Hills
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Frederick
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Saint Paul
country: United States
state: Minnesota
city: Chesterfield
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Somerset
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Wichita Falls
country: United States
state: Texas
city: Bennington
country: United States
state: Vermont
city: Charlottesville
country: United States
state: Virginia
city: Marshfield
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Bonn
country: Germany
city: Erlangen
country: Germany
city: Kehl Kork
country: Germany
city: Schwalmstedt-Treysa
country: Germany
city: Budapest
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: Poznan
country: Poland
city: Goteborg
country: Sweden
city: Stockholm
country: Sweden
city: Bern/Biel
country: Switzerland
city: Zurich
country: Switzerland
city: Bucks/London
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Liverpool
country: United Kingdom
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Rosenfeld W, Fountain NB, Kaubrys G, Ben-Menachem E, McShea C, Isojarvi J, Doty P; SP615 Study Investigators. Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years. Epilepsy Behav. 2014 Dec;41:164-70. doi: 10.1016/j.yebeh.2014.09.074. Epub 2014 Oct 27.