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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00698581




Registration number
NCT00698581
Ethics application status
Date submitted
12/06/2008
Date registered
17/06/2008
Date last updated
11/07/2018

Titles & IDs
Public title
A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (= 16 to 75 Years Old) With Partial Onset Seizures
Scientific title
An International, Double-blind, Randomized, Multi-center, Parallel Group, Historical-control Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (= 16 to 75 Years Old) With Partial Onset Seizures With or Without Secondary Generalization
Secondary ID [1] 0 0
2008-000144-14
Secondary ID [2] 0 0
N01276
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
Treatment: Drugs - Brivaracetam
Treatment: Drugs - Brivaracetam

Experimental: Brivaracetam 50 mg - 50 mg/day

Experimental: Brivaracetam 100 mg - 100 mg/day


Treatment: Drugs: Brivaracetam
25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)

Treatment: Drugs: Brivaracetam
25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase - The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722.
Timepoint [1] 0 0
From Week 1 up to Week 17
Secondary outcome [1] 0 0
The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study
Timepoint [1] 0 0
Baseline through Re-conversion (approximately 31 weeks)
Secondary outcome [2] 0 0
The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study
Timepoint [2] 0 0
Baseline through Re-conversion (approximately 31 weeks)
Secondary outcome [3] 0 0
The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study
Timepoint [3] 0 0
Baseline through Re-conversion (approximately 31 weeks)

Eligibility
Key inclusion criteria
- Subjects from 16 to 75 years, both inclusive

- Well-characterized focal epilepsy or epileptic syndrome

- Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not
secondarily generalized per 4 weeks during the 8-week Baseline Period

- Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic
Drugs (AEDs) with the second AED = 50 % of the minimum recommended maintenance dose
Minimum age
16 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Seizure type IA non-motor as only seizure type

- History or presence of seizures occurring too frequently or indistinctly separated to
be reliably counted during the 6 months preceding Visit 1 or during Baseline

- Other serious uncontrolled disease

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
- Chatswood
Recruitment hospital [2] 0 0
- Adelaide
Recruitment hospital [3] 0 0
- Clayton
Recruitment hospital [4] 0 0
- Fitzroy
Recruitment hospital [5] 0 0
- Parkville
Recruitment hospital [6] 0 0
- West Heidelberg
Recruitment postcode(s) [1] 0 0
- Chatswood
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment postcode(s) [4] 0 0
- Fitzroy
Recruitment postcode(s) [5] 0 0
- Parkville
Recruitment postcode(s) [6] 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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
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
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
West Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
Belgium
State/province [20] 0 0
Gent
Country [21] 0 0
Belgium
State/province [21] 0 0
Kortrijk
Country [22] 0 0
Canada
State/province [22] 0 0
Alberta
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Saskatchewan
Country [25] 0 0
Czechia
State/province [25] 0 0
Brno
Country [26] 0 0
Czechia
State/province [26] 0 0
Litomysl
Country [27] 0 0
Czechia
State/province [27] 0 0
Ostava
Country [28] 0 0
Czechia
State/province [28] 0 0
Ostrava-Trebovice
Country [29] 0 0
Czechia
State/province [29] 0 0
Praha 2
Country [30] 0 0
Czechia
State/province [30] 0 0
Praha-4
Country [31] 0 0
Germany
State/province [31] 0 0
Aschaffenburg
Country [32] 0 0
Germany
State/province [32] 0 0
Halle (Saale)
Country [33] 0 0
Germany
State/province [33] 0 0
Mainz
Country [34] 0 0
Germany
State/province [34] 0 0
Regensburg
Country [35] 0 0
Sweden
State/province [35] 0 0
Goteborg
Country [36] 0 0
Sweden
State/province [36] 0 0
Lund
Country [37] 0 0
Sweden
State/province [37] 0 0
Stockholm
Country [38] 0 0
Sweden
State/province [38] 0 0
Uppsala

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

Ethics approval
Ethics application status

Summary
Brief summary
Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited
number of AEDs are approved for use as monotherapy. The objective of this study is to
evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure
patients from combination treatment to monotherapy
Trial website
https://clinicaltrials.gov/show/NCT00698581
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00698581