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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Gen

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.

Detailed Summary:
Sponsor: UCB BIOSCIENCES, Inc.

Current Primary Outcome:

  • 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) ]

    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) ]

    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.



Original Primary Outcome:

  • 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) ]
  • 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) ]
  • 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) ]


Current Secondary Outcome:

  • 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) ]
    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) ]
    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) ]
    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) ]
    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.


Original Secondary Outcome:

  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]


Information By: UCB Pharma

Dates:
Date Received: May 5, 2010
Date Started: May 2010
Date Completion:
Last Updated: March 10, 2015
Last Verified: March 2015