Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy
NCT ID: NCT00504881
Last Updated: 2018-04-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
480 participants
INTERVENTIONAL
2007-10-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Matching Placebo tablets administered twice a day
Placebo
Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 16-week Treatment Period
Brivaracetam
A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
Brivaracetam
Daily oral dose of two equal intakes, morning and evening, Brivaracetam 20 mg/day or Brivaracetam 50 mg/day or Brivaracetam 100 mg/day or Brivaracetam 150 mg/day, in a double-blinded way for the 16-week Treatment Period
Interventions
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Placebo
Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 16-week Treatment Period
Brivaracetam
Daily oral dose of two equal intakes, morning and evening, Brivaracetam 20 mg/day or Brivaracetam 50 mg/day or Brivaracetam 100 mg/day or Brivaracetam 150 mg/day, in a double-blinded way for the 16-week Treatment Period
Eligibility Criteria
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Inclusion Criteria
* Subjects had well-characterized localization-related Epilepsy or generalized Epilepsy according to the International League Against Epilepsy (ILAE) classification
* For subjects suffering from localization-related Epilepsy: subjects had at least 2 Partial-Onset Seizures (POSs) whether or not secondarily generalized per month during the 3 months preceding Visit 1 according to the ILAE classification
* For subjects suffering from localization-related Epilepsy: subjects had at least 4 Partial-Onset Seizures (POSs) whether or not secondarily generalized during the 4-week Baseline Period according to the ILAE classification
* For subjects suffering from generalized Epilepsy: subjects had at least 2 Type II-seizure days per month during the 3 months preceding Visit 1 according to the ILAE classification
* For subjects suffering from generalized Epilepsy: subjects had at least 4 Type II-seizure days during the 4 week Baseline Period according to the ILAE classification
* Subjects were uncontrolled while treated by 1 to 3 permitted concomitant Antiepileptic Drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant AED
Exclusion Criteria
* Subjects with a history or presence of Status Epilepticus during the year preceding Visit 1 or during Baseline
16 Years
70 Years
ALL
No
Sponsors
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UCB Pharma SA
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Graz, , Austria
Innsbrick, , Austria
Linz, , Austria
Vienna, , Austria
Bruges, , Belgium
Godinne, , Belgium
Leuven, , Belgium
Montignies-sur-Sambre, , Belgium
Beroun, , Czechia
Brno, , Czechia
Ostrava Trebovice, , Czechia
Prague, , Czechia
Zlín, , Czechia
Berlin, , Germany
Bernau, , Germany
Bielefeld, , Germany
Erlangen, , Germany
Göttingen, , Germany
Jena, , Germany
München, , Germany
Hong Kong, , Hong Kong
Bangalore, , India
Hyderabad, , India
Mumbai, , India
New Delhi, , India
Pune Maharashtra, , India
Tirupati, , India
Bari, , Italy
Milan, , Italy
Pavia, , Italy
Roma, , Italy
Siena, , Italy
Bergen, , Norway
Fredrikstad, , Norway
Oslo, , Norway
Sandvika, , Norway
Trondheim, , Norway
Kazan', , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Yaroslavi, , Russia
Singapore, , Singapore
Cape Town, , South Africa
George, , South Africa
Johannesburg, , South Africa
Tygeberg, , South Africa
Gwangju, , South Korea
Seoul, , South Korea
Gothenburg, , Sweden
Stockholm, , Sweden
Umeå, , Sweden
Taichung, , Taiwan
Tainan City, , Taiwan
Taoyuan Hsien, , Taiwan
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Uzhhorod, , Ukraine
Countries
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References
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Kwan P, Trinka E, Van Paesschen W, Rektor I, Johnson ME, Lu S. Adjunctive brivaracetam for uncontrolled focal and generalized epilepsies: results of a phase III, double-blind, randomized, placebo-controlled, flexible-dose trial. Epilepsia. 2014 Jan;55(1):38-46. doi: 10.1111/epi.12391. Epub 2013 Oct 3.
Mukuria C, Young T, Keetharuth A, Borghs S, Brazier J. Sensitivity and responsiveness of the EQ-5D-3L in patients with uncontrolled focal seizures: an analysis of Phase III trials of adjunctive brivaracetam. Qual Life Res. 2017 Mar;26(3):749-759. doi: 10.1007/s11136-016-1483-3. Epub 2016 Dec 21.
Bresnahan R, Panebianco M, Marson AG. Brivaracetam add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2022 Mar 14;3(3):CD011501. doi: 10.1002/14651858.CD011501.pub3.
Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.
Other Identifiers
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2006-006346-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
N01254
Identifier Type: -
Identifier Source: org_study_id
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