Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01118949
First received: May 5, 2010
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

The purpose is to assess the safety of Lacosamide in subjects with uncontrolled Primary Generalized Tonic-Clonic (PGTC) seizures with Idiopathic Generalized Epilepsy.


Condition Intervention Phase
Epilepsy
Drug: Lacosamide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase [ Time Frame: From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13) ] [ Designated as safety issue: No ]

    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 [ Time Frame: From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13) ] [ Designated as safety issue: No ]

    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) [ Time Frame: From Visit 2 (Week 4) to Visit 6 (Week 8) ] [ Designated as safety issue: No ]
    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) [ Time Frame: From Visit 2 (Week 4) to Visit 6 (Week 8) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Visit 2 (Week 4) to Visit 7 (Week 13) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Visit 2 (Week 4) to Visit 7 (Week 13) ] [ Designated as safety issue: No ]
    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.


Enrollment: 49
Study Start Date: May 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacosamide Drug: Lacosamide
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.
Other Name: Vimpat®

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has a diagnosis of uncontrolled epilepsy with primary generalized tonic-clonic seizures and idiopathic generalized epilepsy. Diagnosis should have been established by an 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118949

  Hide Study Locations
Locations
United States, Alabama
Alabaster, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
San Francisco, California, United States
United States, Colorado
Aurora, Colorado, United States
United States, Georgia
Atlanta, Georgia, United States
Rome, Georgia, United States
United States, Idaho
Boise, Idaho, United States
United States, Indiana
Fort Wayne, Indiana, United States
United States, Kentucky
Lexington, Kentucky, United States
Louisville, Kentucky, United States
United States, Maine
Scarborough, Maine, United States
United States, Maryland
Bethesda, Maryland, United States
United States, Missouri
Chesterfield, Missouri, United States
United States, New York
New York, New York, United States
United States, Ohio
Columbus, Ohio, United States
United States, Pennsylvania
Hershey, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
United States, Virginia
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
United States, Washington
Renton, Washington, United States
United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01118949     History of Changes
Other Study ID Numbers: SP0961
Study First Received: May 5, 2010
Results First Received: August 8, 2012
Last Updated: August 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB Pharma:
Primary Generalized Tonic-Clonic (PGTC) Seizures
Absence Seizures
Myoclonic Seizures
Idiopathic Generalized Epilepsy (IGE)

Additional relevant MeSH terms:
Seizures
Epilepsy
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lacosamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014