Clinical trial NCT01118949: Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
Official title: An Open-Label Pilot Study to Assess the Safety of Oral Lacosamide as Adjunctive Therapy 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: 49
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 assess the safety of Lacosamide in subjects with uncontrolled Primary Generalized Tonic-Clonic (PGTC) seizures with Idiopathic Generalized Epilepsy.


Eligibility criteria: Inclusion Criteria:

* Subject has a diagnosis of uncontrolled epilepsy with primary generalized tonic-clonic (PGTC) seizures and idiopathic generalized epilepsy. Diagnosis should have been established by an electroencephalogram (EEG) with generalized spike-wave discharges within 5 years of the screening visit
* Subject has ≥1 PGTC seizure within the 12 weeks prior to the screening visit
* Subject has a stable dose regimen of 1 to 3 marketed antiepileptic drug(s) (AEDs) with or without additional concurrent stable Vagus Nerve Stimulation (VNS). The VNS must have been in place for at least 6 months prior to study entry with constant settings for at least 28 days prior to the screening visit and during the Baseline Phase. Benzodiazepines will be counted as an AED

Exclusion Criteria:

* Subject has a history of partial-onset seizures or EEG findings consistent with partial onset seizures
* Subject has a history of status epilepticus within the 5-year Period prior to Visit 1
* Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events
* Subject has any medical or psychiatric condition
* Subject has any history of alcohol or drug abuse
* Subject is currently taking felbamate
* Subject has ever taken vigabatrin and has no visual fields examination report available or if results of the examination are abnormal
* Subject is on a ketogenic diet
* Subject has a known sodium channelopathy

Primary outcomes:
measure: Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase
timeFrame: From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)
measure: Change in the Number of Seizure Days With Myoclonic Seizures From the Baseline Phase to the Maintenance Phase
timeFrame: From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)
Secondary outcomes:
measure: Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)
timeFrame: From Visit 2 (Week 4) to Visit 6 (Week 8)
measure: Changes in Count of 3 Hertz (Hz) Spike-wave Discharges (During Waking Hours) on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)
timeFrame: From Visit 2 (Week 4) to Visit 6 (Week 8)
measure: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period
timeFrame: From Visit 2 (Week 4) to Visit 7 (Week 13)
measure: Number of Subjects Withdrawn From the Study Due to Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period
timeFrame: From Visit 2 (Week 4) to Visit 7 (Week 13)
Other outcomes:
Locations:
city: Alabaster
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: San Francisco
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Atlanta
country: United States
state: Georgia
city: Rome
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Fort Wayne
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Scarborough
country: United States
state: Maine
city: Bethesda
country: United States
state: Maryland
city: Chesterfield
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Renton
country: United States
state: Washington
city: Madison
country: United States
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.