Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
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
2 other identifiers
interventional
49
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2010
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 5, 2010
CompletedFirst Posted
Study publicly available on registry
May 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
September 7, 2012
CompletedJuly 17, 2018
March 1, 2018
1.3 years
May 5, 2010
August 8, 2012
June 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase
During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded: * Seizure type * Seizure frequency A negative value in change of seizure days with absence seizures shows a decrease in seizure days with absence seizures.
From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)
Change in the Number of Seizure Days With Myoclonic Seizures From the Baseline Phase to the Maintenance Phase
During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded: * Seizure type * Seizure frequency A negative value in change of seizure days with myoclonic seizures shows a decrease in seizure days with myoclonic seizures.
From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)
Secondary Outcomes (4)
Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)
From Visit 2 (Week 4) to Visit 6 (Week 8)
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)
From Visit 2 (Week 4) to Visit 6 (Week 8)
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period
From Visit 2 (Week 4) to Visit 7 (Week 13)
Number of Subjects Withdrawn From the Study Due to Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period
From Visit 2 (Week 4) to Visit 7 (Week 13)
Study Arms (1)
Lacosamide
EXPERIMENTALInterventions
Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
Alabaster, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Aurora, Colorado, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Rome, Georgia, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Fort Wayne, Indiana, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Scarborough, Maine, United States
Unknown Facility
Bethesda, Maryland, United States
Unknown Facility
Chesterfield, Missouri, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Hershey, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Charlottesville, Virginia, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Renton, Washington, United States
Unknown Facility
Madison, Wisconsin, United States
Related Publications (1)
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.
PMID: 28086164RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
May 5, 2010
First Posted
May 7, 2010
Study Start
May 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
July 17, 2018
Results First Posted
September 7, 2012
Record last verified: 2018-03