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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00464269




Registration number
NCT00464269
Ethics application status
Date submitted
19/04/2007
Date registered
23/04/2007
Date last updated
21/07/2022

Titles & IDs
Public title
Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures
Scientific title
An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures
Secondary ID [1] 0 0
2006-006345-14
Secondary ID [2] 0 0
N01253
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Other interventions - Placebo
Treatment: Drugs - Brivaracetam 2.5 mg
Treatment: Drugs - Brivaracetam 10 mg
Treatment: Drugs - Brivaracetam 25 mg

Placebo comparator: Placebo - Matching Placebo tablets administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period.

Experimental: Brivaracetam 5 mg/day - Brivaracetam 5 mg/day, 2.5 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 5 mg /day in a double-blinded way for the 12-week Treatment Period.

Experimental: BRV 20mg/day - Brivaracetam 20 mg/day, 10 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg /day in a double-blinded way for the 12-week Treatment Period.

Experimental: BRV 50mg/day - Brivaracetam 50 mg/day, 25 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg /day, in a double-blinded way for the 12-week Treatment Period.


Other interventions: Placebo
* Active Substance: Placebo
* Pharmaceutical Form: Film-coated tablet
* Concentration: 2.5 mg, 10 mg and 25 mg
* Route of Administration: Oral use

Treatment: Drugs: Brivaracetam 2.5 mg
* Active Substance: Brivaracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 2.5 mg
* Route of Administration: Oral use

Treatment: Drugs: Brivaracetam 10 mg
* Active Substance: Brivaracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 10 mg
* Route of Administration: Oral use

Treatment: Drugs: Brivaracetam 25 mg
* Active Substance: Brivaracetam
* Pharmaceutical Form: Film-coated tablet
* Concentration: 25 mg
* Route of Administration: Oral use
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period
Timepoint [1] 0 0
Baseline to 12-week Treatment Period
Secondary outcome [1] 0 0
Responder Rate for Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period
Timepoint [1] 0 0
Baseline to 12-week Treatment Period
Secondary outcome [2] 0 0
All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period
Timepoint [2] 0 0
Baseline to 12-week Treatment Period
Secondary outcome [3] 0 0
Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week
Timepoint [3] 0 0
Baseline to 12-week Treatment Period
Secondary outcome [4] 0 0
Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period
Timepoint [4] 0 0
Baseline to 12-week Treatment Period
Secondary outcome [5] 0 0
Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period
Timepoint [5] 0 0
Baseline to 12-week Treatment Period
Secondary outcome [6] 0 0
Time to First Type I Seizure During the 12-week Treatment Period
Timepoint [6] 0 0
Baseline to 12-week Treatment Period
Secondary outcome [7] 0 0
Time to Fifth Type I Seizure During the 12-week Treatment Period
Timepoint [7] 0 0
Baseline to 12-week Treatment Period
Secondary outcome [8] 0 0
Time to Tenth Type I Seizure During the 12-week Treatment Period
Timepoint [8] 0 0
Baseline to 12-week Treatment Period
Secondary outcome [9] 0 0
Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period
Timepoint [9] 0 0
Baseline to 12-week Treatment Period
Secondary outcome [10] 0 0
Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Timepoint [10] 0 0
Baseline to 12-week Treatment Period
Secondary outcome [11] 0 0
Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Timepoint [11] 0 0
Baseline to 12-week Treatment Period
Secondary outcome [12] 0 0
Change From Baseline to the 12-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Timepoint [12] 0 0
Baseline to 12-week Treatment Period
Secondary outcome [13] 0 0
Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score
Timepoint [13] 0 0
Baseline to 12-week Treatment Period
Secondary outcome [14] 0 0
Change From Baseline to the 12-week Treatment Period in Hospital Depression Score
Timepoint [14] 0 0
Baseline to 12-week Treatment Period
Secondary outcome [15] 0 0
Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit
Timepoint [15] 0 0
Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period
Secondary outcome [16] 0 0
Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit
Timepoint [16] 0 0
Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period
Secondary outcome [17] 0 0
Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Timepoint [17] 0 0
From Baseline to 12-week Treatment Period
Secondary outcome [18] 0 0
Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Timepoint [18] 0 0
From Baseline to 12-week Treatment Period
Secondary outcome [19] 0 0
Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Timepoint [19] 0 0
From Baseline to 12-week Treatment Period
Secondary outcome [20] 0 0
Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Timepoint [20] 0 0
From Baseline to 12-week Treatment Period
Secondary outcome [21] 0 0
Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Timepoint [21] 0 0
From Baseline to 12-week Treatment Period
Secondary outcome [22] 0 0
Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
Timepoint [22] 0 0
From Baseline to 12-week Treatment Period

Eligibility
Key inclusion criteria
* Subjects were 16 to 70 years, both inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted
* Subjects with well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
* Subjects had a history of partial onset seizures (POS) whether or not secondarily generalized (Type I seizures according to the ILAE classification)
* Subjects had at least 2 POS whether or not secondarily generalized per month during the 3 months preceding Visit 1 (V1)
* Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week Baseline Period
* Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic drug(s) (AEDs). Vagal nerve stimulation (VNS) was allowed and was not counted as a concomitant AED
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 3
* History or presence of status epilepticus during the year preceding Visit 1 or during Baseline

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2009
Sample size
Target
Accrual to date
Final
400
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
- Chatswood
Recruitment hospital [2] 0 0
- Randwick
Recruitment hospital [3] 0 0
- Woodville
Recruitment hospital [4] 0 0
- Clayton
Recruitment hospital [5] 0 0
- Fitzroy
Recruitment hospital [6] 0 0
- Parkville
Recruitment hospital [7] 0 0
- Adelaide
Recruitment hospital [8] 0 0
- West Heidelberg
Recruitment postcode(s) [1] 0 0
- Chatswood
Recruitment postcode(s) [2] 0 0
- Randwick
Recruitment postcode(s) [3] 0 0
- Woodville
Recruitment postcode(s) [4] 0 0
- Clayton
Recruitment postcode(s) [5] 0 0
- Fitzroy
Recruitment postcode(s) [6] 0 0
- Parkville
Recruitment postcode(s) [7] 0 0
- Adelaide
Recruitment postcode(s) [8] 0 0
- West Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
United States of America
State/province [25] 0 0
Wisconsin
Country [26] 0 0
Brazil
State/province [26] 0 0
Campinas
Country [27] 0 0
Brazil
State/province [27] 0 0
Curitiba
Country [28] 0 0
Brazil
State/province [28] 0 0
Florianópolis
Country [29] 0 0
Brazil
State/province [29] 0 0
Porto Alegre
Country [30] 0 0
Brazil
State/province [30] 0 0
Ribeirao Preto
Country [31] 0 0
Brazil
State/province [31] 0 0
Salvador
Country [32] 0 0
Brazil
State/province [32] 0 0
Sao Jose do Rio Preto
Country [33] 0 0
Brazil
State/province [33] 0 0
Sao Paulo
Country [34] 0 0
Brazil
State/province [34] 0 0
São Paulo
Country [35] 0 0
Canada
State/province [35] 0 0
Alberta
Country [36] 0 0
Canada
State/province [36] 0 0
Quebec
Country [37] 0 0
Mexico
State/province [37] 0 0
DF
Country [38] 0 0
Mexico
State/province [38] 0 0
NL
Country [39] 0 0
Mexico
State/province [39] 0 0
Aguascalientes
Country [40] 0 0
Mexico
State/province [40] 0 0
Chihuahua
Country [41] 0 0
Mexico
State/province [41] 0 0
Mexico DF
Country [42] 0 0
Mexico
State/province [42] 0 0
Monterrey
Country [43] 0 0
Mexico
State/province [43] 0 0
Nuevo León
Country [44] 0 0
Mexico
State/province [44] 0 0
San Luis Potosi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Pharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
Address 0 0
+1 877 822 9493 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Biton V, Berkovic SF, Abou-Khalil B, Sperling MR, ... [More Details]
Journal Toledo M, Whitesides J, Schiemann J, Johnson ME, E... [More Details]
Journal Ben-Menachem E, Mameniskiene R, Quarato PP, Klein ... [More Details]
Journal Brodie MJ, Whitesides J, Schiemann J, D'Souza J, J... [More Details]
Journal Mukuria C, Young T, Keetharuth A, Borghs S, Brazie... [More Details]
Journal Moseley BD, Sperling MR, Asadi-Pooya AA, Diaz A, E... [More Details]
Journal Brandt C, Borghs S, Elmoufti S, Mueller K, Townsen... [More Details]
Journal Klein P, Johnson ME, Schiemann J, Whitesides J. Ti... [More Details]
Journal Asadi-Pooya AA, Sperling MR, Chung S, Klein P, Dia... [More Details]
Journal Benbadis S, Klein P, Schiemann J, Diaz A, Elmoufti... [More Details]
Journal Brodie MJ, Fakhoury T, McDonough B, Colson AO, Sto... [More Details]
Journal Klein P, Laloyaux C, Elmoufti S, Gasalla T, Martin... [More Details]
Journal Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asad... [More Details]
Journal Ryvlin P, Dimova S, Elmoufti S, Floricel F, Laloya... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00464269