Clinical trial NCT00522275: Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
Official title: An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 in Patients With Partial Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Partial Epilepsies
Keywords: Adjunctive treatment in epilepsy
add-on treatment for epilepsy
partial seizures
AEDs
antiepileptic drugs
seizures
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-08-29
Enrollment: 308
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
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 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
timeFrame: During the Treatment Period (Maximum 6 years)
measure: Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
timeFrame: During the Treatment Period (Maximum 6 years)
measure: Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)
timeFrame: During the Treatment Period (Maximum 6 years)
Secondary outcomes:
measure: Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)
timeFrame: Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)
measure: Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)
timeFrame: Treatment Period (Maximum 6 years)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Englewood
country: United States
state: Colorado
city: Fairfield
country: United States
state: Connecticut
city: Bradenton
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Bethesda
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Golden Valley
country: United States
state: Minnesota
city: Saint Cloud
country: United States
state: Minnesota
city: Saint Paul
country: United States
state: Minnesota
city: Chesterfield
country: United States
state: Missouri
city: Somerset
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Winston-Salem
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: Toledo
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Beaufort
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Newport News
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
city: Marshfield
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Husain A, Chung S, Faught E, Isojarvi J, McShea C, Doty P. Long-term safety and efficacy in patients with uncontrolled partial-onset seizures treated with adjunctive lacosamide: results from a Phase III open-label extension trial. Epilepsia. 2012 Mar;53(3):521-8. doi: 10.1111/j.1528-1167.2012.03407.x.