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

May 5, 2010
August 8, 2012
May 2010
August 2011   (final data collection date for primary outcome measure)
  • 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.

  • Change in the number of seizure days with absence seizures from the Baseline Phase (Weeks 0 to 4) to the Maintenance Phase (Weeks 8 to 13) [ Time Frame: Baseline Phase (Weeks 0 to 4), Maintenance Phase (Weeks 8 to 13) ] [ Designated as safety issue: No ]
  • Change in the number of seizure days with myoclonic seizures from the Baseline Phase (Weeks 0 to 4) to the Maintenance Phase (Weeks 8 to 13) [ Time Frame: Baseline Phase (Weeks 0 to 4), Maintenance Phase (Weeks 8 to 13) ] [ Designated as safety issue: No ]
  • Percentage change in primary generalized tonic-clonic (PGTC) seizure frequency per 28 days from the Baseline Phase (Weeks 0 to 4) to the Maintenance Phase (weeks 8 to 13) [ Time Frame: Baseline Phase (Weeks 0 to 4), Maintenance Phase (Weeks 8 to 13) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01118949 on ClinicalTrials.gov Archive Site
  • 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.
  • 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: Visit 2 (i.e., Week 4), Visit 6 (i.e., Week 8) ] [ Designated as safety issue: No ]
  • Changes in count of 3 Hertz (Hz) spike-wave discharges on 24-hour ambulatory electrocardiogram (ECG) from Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase) [ Time Frame: Visit 2 (i.e., Week 4), Visit 6 (i.e., Week 8) ] [ Designated as safety issue: No ]
  • Number of participants with treatment emergent adverse events (TEAEs) during the 10-week treatment period [ Time Frame: Visit 2 (i.e., Week 4) to Visit 7 (i.e., Week 13) ] [ Designated as safety issue: No ]
  • Number of participants withdrawn from the study due to treatment emergent adverse events (TEAEs) during the 10-week treatment period [ Time Frame: Visit 2 (i.e., Week 4) to Visit 7 (i.e., Week 13) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
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®
Experimental: Lacosamide
Intervention: Drug: Lacosamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
16 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01118949
SP0961
Yes
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP