Clinical trial NCT00504881: Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy
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) Suffering From Localization-related or Generalized Epilepsy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Epilepsy
Brivaracetam
Partial Onset Seizures
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-07-20
Enrollment: 480
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Subjects were aged from 16 to 70 years, inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted
* 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:

* For subjects who suffered from localization-related Epilepsy: history or presence of Seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 2 or occurring only as Type IA non-motor
* Subjects with a history or presence of Status Epilepticus during the year preceding Visit 1 or during Baseline

Primary outcomes:
measure: Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period
timeFrame: Week 2 to the end of the Treatment Period (Week 16)
measure: Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period
timeFrame: Baseline (Week 0) to the end of the Treatment Period (Week 16)
Secondary outcomes:
measure: Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period
timeFrame: Baseline (Week 0) to the end of Treatment Period (Week 16)
measure: Seizure Frequency (All Seizure Types) Per Week Over the 16-week Treatment Period
timeFrame: Baseline (Week 0) to the end of Treatment Period (Week 16)
measure: Percent Change From Baseline to the 16-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week
timeFrame: Baseline (Week 0) to end of Treatment Period (Week 16)
measure: Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period
timeFrame: Baseline to 16-week Treatment Period
measure: Seizure Freedom Rate (All Seizure Types) Over the 16-week Treatment Period
timeFrame: Baseline (Week 0) to the end of Treatment Period (Week 16)
measure: Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 16-week Treatment Period
timeFrame: Baseline to 16-week Treatment Period
measure: Time to First Type I Seizure During the 16-week Treatment Period
timeFrame: Baseline to 16-week Treatment Period
measure: Time to Fifth Type I Seizure During the 16-week Treatment Period
timeFrame: Baseline to 16-week Treatment Period
measure: Time to Tenth Type I Seizure During Treatment Period
timeFrame: Baseline to 16-week Treatment Period
measure: 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
timeFrame: Baseline to 16-week Treatment Period
measure: Change From Baseline to the 16-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
timeFrame: Baseline to 16-week Treatment Period
measure: Change From Baseline to the 16-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
timeFrame: Baseline to 16-week Treatment Period
measure: Change From Baseline to the 16-week Treatment Period in Hospital Anxiety Score
timeFrame: Baseline to 16-week Treatment Period
measure: Change From Baseline to the 16-week Treatment Period in Hospital Depression Score
timeFrame: Baseline to 16-week Treatment Period
measure: Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit
timeFrame: Baseline to last visit or early discontinuation visit in the 16-week Treatment Period
measure: Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit
timeFrame: Baseline to Last Visit or Early Discontinuation Visit in the 16-week Treatment Period
measure: Change From Baseline to the 16-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
timeFrame: Baseline to 16-week Treatment Period
measure: Change From Baseline to the 16-week Treatment Period in Emotional Well-being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
timeFrame: Baseline to 16-week Treatment Period
measure: Change From Baseline to the 16-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
timeFrame: Baseline to 16-week Treatment Period
measure: Change From Baseline to the 16-week Treatment Period in Overall Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
timeFrame: Baseline to 16-week Treatment Period
measure: Change From Baseline to the 16-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
timeFrame: Baseline to 16-week Treatment Period
Other outcomes:
Locations:
city: Graz
country: Austria
city: Innsbrick
country: Austria
city: Linz
country: Austria
city: Vienna
country: Austria
city: Wien
country: Austria
city: Brugge
country: Belgium
city: Godinne
country: Belgium
city: Leuven
country: Belgium
city: Montignies Sur Sambre
country: Belgium
city: Beroun
country: Czechia
city: Brno
country: Czechia
city: Ostrava Trebovice
country: Czechia
city: Praha 2
country: Czechia
city: Praha 5
country: Czechia
city: Zlin
country: Czechia
city: Berlin
country: Germany
city: Bernau
country: Germany
city: Bielefeld
country: Germany
city: Erlangen
country: Germany
city: Göttingen
country: Germany
city: Jena
country: Germany
city: München
country: Germany
city: Hong Kong
country: Hong Kong
city: Bangalore
country: India
city: Hyderabad
country: India
city: Mumbai
country: India
city: New Delhi
country: India
city: Pune Maharashtra
country: India
city: Tirupati
country: India
city: Bari
country: Italy
city: Milano
country: Italy
city: Pavia
country: Italy
city: Roma
country: Italy
city: Siena
country: Italy
city: Gwangju
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Bergen
country: Norway
city: Fredrikstad
country: Norway
city: Oslo
country: Norway
city: Sandvika
country: Norway
city: Trondheim
country: Norway
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
city: Samara
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Yaroslavi
country: Russian Federation
city: Singapore
country: Singapore
city: Cape Town
country: South Africa
city: George
country: South Africa
city: Johannesburg
country: South Africa
city: Tygeberg
country: South Africa
city: Göteborg
country: Sweden
city: Stockholm
country: Sweden
city: Umea
country: Sweden
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taoyuan Hsien
country: Taiwan
city: Donetsk
country: Ukraine
city: Kharkov
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Uzhgorod
country: Ukraine
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.