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A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.

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ClinicalTrials.gov Identifier: NCT00175825
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : August 22, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
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Brief Summary:
This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.

Condition or disease Intervention/treatment Phase
Epilepsy Other: Placebo Drug: Brivaracetam Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, 4 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment at Doses of 5, 20 and 50 mg/Day in b.i.d. Administration (Oral Tablets of 2.5 or 10 mg) for a Maximum of 7 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized
Actual Study Start Date : November 7, 2005
Actual Primary Completion Date : June 29, 2006
Actual Study Completion Date : June 29, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Matching Placebo tablets administered twice a day
 Other: Placebo
Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period
Experimental: Brivaracetam 5 mg/day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
 Drug: Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period
Other Name: Briviact
Experimental: Brivaracetam 20 mg/day
Brivaracetam 20 mg/day, 10 mg administered twice a day
 Drug: Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period
Other Name: Briviact
Experimental: Brivaracetam 50 mg/day
Brivaracetam 50 mg/day, 25 mg administered twice a day
 Drug: Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period
Other Name: Briviact


Outcome Measures
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Primary Outcome Measures :
  1. Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period [ Time Frame: During the 7-week Treatment Period ]
    Calculated as 7-day partial onset seizure frequency.


Secondary Outcome Measures :
  1. Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period [ Time Frame: Baseline, during the 7-week Treatment Period ]
    Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.

  2. Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period [ Time Frame: During the 7-week Treatment Period ]
    Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or nonconvulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 7-day period.

  3. Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period [ Time Frame: During the 7-week Treatment Period ]
    Calculated as 7-day Partial Onset Seizures (Type I) frequency during the 7-week Treatment Period 7-day seizure frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.

  4. Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period [ Time Frame: During the 7-week Treatment Period ]
    Calculated as 7-day seizure frequency during the 7-week Treatment Period 7-day seizure (Types I + II + III) frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.

  5. Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period [ Time Frame: During the 7-week Treatment Period ]
    Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.

  6. Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period [ Time Frame: During the 7-week Treatment Period ]
    A responder was defined as a subject with a >= 50 % reduction in seizure frequency per week from the Baseline Period to the end of the Treatment Period.

  7. Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period [ Time Frame: During the 7-week Treatment Period ]
    Categories of percentage reductions in seizures from baseline were as following: < -25 %; -25 % to <25 %; 25 % to <75 %; 75 % to <100 %; 100 %.

  8. Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period [ Time Frame: During the 7-week Treatment Period ]
    A subject was considered seizure free, if no seizure was reported during the 7-week Treatment Period.

  9. Number of Seizure-free Days Per 4 Weeks [ Time Frame: Baseline, during the 7-week Treatment Period ]
    A day was considered seizure-free, if no seizure was reported during 24 hours.

  10. Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period [ Time Frame: During the 7-week Treatment Period ]
    Number of days to first, fifth, and tenth seizure after baseline.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male/female from 16 to 65 years
  • Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
  • History of partial onset seizures
  • Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1
  • Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.

Exclusion Criteria:

  • Seizure type IA non-motor as only seizure type
  • Seizures occurring only in clusters
  • Status epilepticus during the last 2 years before Visit 1
  • History of cerebrovascular accident (CVA)
  • Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175825


Locations
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United States, Arizona
Phoenix, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Fresno, California, United States
United States, Florida
Bradenton, Florida, United States
Jacksonville, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kentucky
Paducah, Kentucky, United States
United States, Louisiana
Ruston, Louisiana, United States
United States, Maryland
Bethesda, Maryland, United States
United States, Massachusetts
Burlington, Massachusetts, United States
United States, Michigan
Grand Rapids, Michigan, United States
United States, Minnesota
Rochester, Minnesota, United States
United States, Mississippi
Tupelo, Mississippi, United States
United States, Missouri
Chesterfield, Missouri, United States
United States, Montana
Great Falls, Montana, United States
United States, New Jersey
Englewood Cliffs, New Jersey, United States
Toms River, New Jersey, United States
United States, New York
New York, New York, United States
United States, North Carolina
Wilmington, North Carolina, United States
United States, Ohio
Columbus, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Rhode Island
Woonsocket, Rhode Island, United States
United States, South Carolina
Greenville, South Carolina, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Brazil
Florianopolis, Brazil
Salvador, Brazil
Sao Paulo, Brazil
India
Bangalore, India
Hyderabad, India
Lucknow, India
Parel Mumbai, India
Trivandrum, India
Mexico
Aguascalientes, Mexico
Chichuahua, Mexico
Chihuahua, Mexico
Guadalajara, Mexico
Monterrey, Mexico
San Luis Potosi, Mexico
Valle Oriente Garza Garcia, Mexico
Zapopan, Mexico
Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Cares +1 844 599 2273 (UCB)
More Information
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Additional Information:
Product Information  This link exits the ClinicalTrials.gov site FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

Publications of Results:

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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00175825    
Other Study ID Numbers: N01193
First Posted: September 15, 2005    Key Record Dates
Results First Posted: August 22, 2018
Last Update Posted: October 2, 2018
Last Verified: September 2018
Keywords provided by UCB Pharma:
Epilepsy: partial onset seizures
brivaracetam
Additional relevant MeSH terms:
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Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurologic Manifestations
Signs and Symptoms
Brivaracetam
Anticonvulsants