Clinical trial NCT01118962: Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
Official title: An Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Long-Term Oral Lacosamide for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Keywords: Primary Generalized Tonic-Clonic (PGTC) Seizures
Absence Seizures
Myoclonic Seizures
Idiopathic Generalized Epilepsy (IGE)
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-05-07
Enrollment: 39
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose is to obtain data on the safety and seizure frequency associated with long-term oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed SP0961 (NCT01118949) to continue to receive Lacosamide.


Eligibility criteria: Inclusion Criteria:

* Subject completed the SP0961 (NCT01118949) study
* Subject is expected to benefit from participation in an open-label extension study with Lacosamide, in the opinion of the investigator

Exclusion Criteria:

* Subject meets the withdrawal criteria for SP0961 (NCT01118949) or is experiencing an ongoing Serious Adverse Event (SAE)

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)
timeFrame: From Visit 1 to the end of study (Approximately 61 weeks)
measure: Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)
timeFrame: From Visit 1 to the end of study (Approximately 61 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: 603
state: Arizona
city: Little Rock
country: United States
facility: 602
state: Arkansas
city: Aurora
country: United States
facility: 628
state: Colorado
city: Atlanta
country: United States
facility: 613
state: Georgia
city: Boise
country: United States
facility: 617
state: Idaho
city: Fort Wayne
country: United States
facility: 614
state: Indiana
city: Lexington
country: United States
facility: 605
state: Kentucky
city: Louisville
country: United States
facility: 616
state: Kentucky
city: Scarborough
country: United States
facility: 619
state: Maine
city: Bethesda
country: United States
facility: 609
state: Maryland
city: Chesterfield
country: United States
facility: 615
state: Missouri
city: New York
country: United States
facility: 607
state: New York
city: Columbus
country: United States
facility: 620
state: Ohio
city: Charleston
country: United States
facility: 608
state: South Carolina
city: Nashville
country: United States
facility: 601
state: Tennessee
city: Dallas
country: United States
facility: 612
state: Texas
city: Norfolk
country: United States
facility: 610
state: Virginia
city: Renton
country: United States
facility: 623
state: Washington
city: Madison
country: United States
facility: 624
state: Wisconsin
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Wechsler RT, Yates SL, Messenheimer J, Leroy R, Beller C, Doty P. Lacosamide for uncontrolled primary generalized tonic-clonic seizures: An open-label pilot study with 59-week extension. Epilepsy Res. 2017 Feb;130:13-20. doi: 10.1016/j.eplepsyres.2016.12.015. Epub 2016 Dec 29.