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Trial record 100 of 146 for:    epilepsy AND Bethesda

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 15, 2005
Results First Submitted Date  ICMJE October 26, 2017
Results First Posted Date  ICMJE August 22, 2018
Last Update Posted Date October 2, 2018
Actual Study Start Date  ICMJE November 7, 2005
Actual Primary Completion Date June 29, 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
To evaluate the efficacy of brivaracetam by measuring the reduction in seizure frequency over 7 weeks.
Change History Complete list of historical versions of study NCT00175825 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 %.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • • To evaluate the safety and tolerability of brivaracetam in partial onset seizures
  • • To narrow down the dose range of clinical interest
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • 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
  • Drug: Brivaracetam
    Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period
    Other Name: Briviact
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Matching Placebo tablets administered twice a day
    Intervention: Other: Placebo
  • Experimental: Brivaracetam 5 mg/day
    Brivaracetam 5 mg/day, 2.5 mg administered twice a day
    Intervention: Drug: Brivaracetam
  • Experimental: Brivaracetam 20 mg/day
    Brivaracetam 20 mg/day, 10 mg administered twice a day
    Intervention: Drug: Brivaracetam
  • Experimental: Brivaracetam 50 mg/day
    Brivaracetam 50 mg/day, 25 mg administered twice a day
    Intervention: Drug: Brivaracetam
Publications * Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016 Jul;57(7):1139-51. doi: 10.1111/epi.13416. Epub 2016 Jun 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2010)
210
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
204
Actual Study Completion Date  ICMJE June 29, 2006
Actual Primary Completion Date June 29, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   India,   Mexico,   United States
Removed Location Countries Panama
 
Administrative Information
NCT Number  ICMJE NCT00175825
Other Study ID Numbers  ICMJE N01193
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Cares +1 844 599 2273 (UCB)
PRS Account UCB Pharma
Verification Date September 2018

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