Back to resultsOpen-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lacosamide
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Primary Generalized Tonic-Clonic (PGTC) Seizures, Absence Seizures, Myoclonic Seizures, Idiopathic Generalized Epilepsy (IGE)
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lacosamide
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)
Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The general spike-wave discharges are calculated per interpretable hours.
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)
Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The 3 Hertz (Hz) spike-wave discharges are calculated per awake hours.
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Number of Subjects Withdrawn From the Study Due to Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01118949
Brief Title
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB BIOSCIENCES, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Primary Generalized Tonic-Clonic (PGTC) Seizures, Absence Seizures, Myoclonic Seizures, Idiopathic Generalized Epilepsy (IGE)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lacosamide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
Vimpat®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase
Description
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.
Time Frame
From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)
Title
Change in the Number of Seizure Days With Myoclonic Seizures From the Baseline Phase to the Maintenance Phase
Description
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.
Time Frame
From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)
Secondary Outcome Measure Information:
Title
Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)
Description
Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The general spike-wave discharges are calculated per interpretable hours.
Time Frame
From Visit 2 (Week 4) to Visit 6 (Week 8)
Title
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)
Description
Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The 3 Hertz (Hz) spike-wave discharges are calculated per awake hours.
Time Frame
From Visit 2 (Week 4) to Visit 6 (Week 8)
Title
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period
Description
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Time Frame
From Visit 2 (Week 4) to Visit 7 (Week 13)
Title
Number of Subjects Withdrawn From the Study Due to Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period
Description
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Time Frame
From Visit 2 (Week 4) to Visit 7 (Week 13)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Alabaster
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
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San Francisco
State/Province
California
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United States
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Aurora
State/Province
Colorado
Country
United States
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Atlanta
State/Province
Georgia
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United States
City
Rome
State/Province
Georgia
Country
United States
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Boise
State/Province
Idaho
Country
United States
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Fort Wayne
State/Province
Indiana
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
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Louisville
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Kentucky
Country
United States
City
Scarborough
State/Province
Maine
Country
United States
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Bethesda
State/Province
Maryland
Country
United States
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Chesterfield
State/Province
Missouri
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United States
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New York
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New York
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United States
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Columbus
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Ohio
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United States
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Hershey
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Pennsylvania
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United States
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Charleston
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South Carolina
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United States
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Nashville
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Tennessee
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United States
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Dallas
State/Province
Texas
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United States
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Houston
State/Province
Texas
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United States
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Charlottesville
State/Province
Virginia
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United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Renton
State/Province
Washington
Country
United States
City
Madison
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28086164
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.
Results Reference
result
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
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