Clinical Trial: Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy

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

Official Title: An International, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Study: Evaluation of the Safety and Efficacy of Brivaracetam in Subjects (≥ 16 to 70 Years Old) Suff

Brief Summary: This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo in subjects suffering from Epilepsy.

Detailed Summary:
Sponsor: UCB Pharma SA

Current Primary Outcome:

  • Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period [ Time Frame: Week 2 to the end of the Treatment Period (Week 16) ]
    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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
  • Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period [ Time Frame: Baseline (Week 0) to the end of the Treatment Period (Week 16) ]

    Partial (Type I) seizures can be classified into one of the following three groups:

    • Simple partial seizures
    • Complex partial seizures
    • Partial seizures evolving to generalized tonic-clonic convulsions.

    Partial Onset Seizure (POS) frequency per week over the Treatment Period (TP) was calculated as:

    (Total Type I seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)



Original Primary Outcome: To assess the safety and tolerability of brivaracetam during 16 weeks of treatment in subjects suffering from localization-related epilepsy or generalized epilepsy. [ Time Frame: 16 weeks ]

Current Secondary Outcome:

  • Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period [ Time Frame: Baseline (Week 0) to the end of Treatment Period (Week 16) ]
    The responder rate was presented as the percentage of responders and non-responders. A subject is a responder, if the subject has at least 50 % reduction in Partial Onset Seizure frequency per week from Baseline to Treatment Period. Subjects with zero seizure frequency per week at Baseline were considered as non-responders.
  • Seizure Frequency (All Seizure Types) Per Week Over the 16-week Treatment Period [ Time Frame: Baseline (Week 0) to the end of Treatment Period (Week 16) ]

    There are three different types of seizures:

    • Type I: Partial seizures
    • Type II: Generalized seizures
    • Type III: Unclassified epileptic seizures. All seizure frequency per week over Treatment Period (TP) was calculated as: (Total number of seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)
  • Percent Change From Baseline to the 16-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week [ Time Frame: Baseline (Week 0) to end of Treatment Period (Week 16) ]

    Percent change from Baseline was calculated as percent reduction by:

    (weekly seizure frequency Baseline - weekly seizure frequency Treatment)*100/(weekly seizure frequency Baseline).

    A negative value in percent Change from Baseline indicates an improvement from Baseline.

    The higher the negative values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline.

  • Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period [ Time Frame: Baseline to 16-week Treatment Period ]

    Subjects were classified in 1 of the following categories based on their percent reduction from Baseline to Treatment Period in Partial Onset Seizure (POS) frequency per week: <-25 %, -25 % to <25 %, 25 % to <50 %, 50 % to <75 %, 75 % to <100 %, and 100 %.

    Subjects having zero for Baseline seizure frequency per week were classified in the <-25 % category.

  • Seizure Freedom Rate (All Seizure Types) Over the 16-week Treatment Period [ Time Frame: Baseline (Week 0) to the end of Treatment Period (Week 16) ]

    Subjects were considered seizure free if their seizure counts for every day over the Treatment Period (TP) was zero and if they did not discontinue before the end of the TP. Seizure freedom rate was calculated as:

    (total number of seizure - free subjects in treatment group during TP)/(total number of evaluable Intent-To-Treat (ITT) subjects in treatment group)

  • Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 16-week Treatment Period [ Time Frame: Baseline to 16-week Treatment Period ]
    The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period.
  • Time to First Type I Seizure During the 16-week Treatment Period [ Time Frame: Baseline to 16-week Treatment Period ]
    Time to first Type I seizure during the 16-week Treatment Period was measured in days.
  • Time to Fifth Type I Seizure During the 16-week Treatment Period [ Time Frame: Baseline to 16-week Treatment Period ]
    Time to fifth Type I seizure during the 16-week Treatment Period was measured in days.
  • Time to Tenth Type I Seizure During Treatment Period [ Time Frame: Baseline to 16-week Treatment Period ]
    Time to tenth Type I seizure during the 16-week Treatment Period was measured in days.
  • Change From Baseline to the 16-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score [ Time Frame: Baseline to 16-week Treatment Period ]
    The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into 7 multi-item subscales: Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items), and a Health Status item. In addition to the 31 items of the QOLIE-31, the QOLIE-31-P con

    Original Secondary Outcome: To confirm the efficacy of brivaracetam during 16 weeks of treatment in reducing the partial onset seizure frequency, to assess its effect on the patients Health-related quality of life and to assess its efficacy in reducing seizure days in the epileptic [ Time Frame: 16 weeks ]

    Information By: UCB Pharma

    Dates:
    Date Received: July 19, 2007
    Date Started: October 2007
    Date Completion:
    Last Updated: January 27, 2017
    Last Verified: January 2017