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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00761774




Registration number
NCT00761774
Ethics application status
Date submitted
26/09/2008
Date registered
30/09/2008
Date last updated
11/07/2018

Titles & IDs
Public title
An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam
Scientific title
An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy.
Secondary ID [1] 0 0
2008-001433-98
Secondary ID [2] 0 0
N01315
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

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Brivaracetam

Experimental: Brivaracetam - Brivaracetam at flexible dosing up to 200mg /day


Treatment: Drugs: Brivaracetam
Subjects will begin at a recommended dose of Brivaracetam 100 mg/day. Subjects will continue treatment at a dose up to a maximum of 200 mg/day with a twice per day administration. Up- and down-titration steps may be performed in steps of a maximum of 50 mg/day on a weekly basis. Full down-titration should include a one week step on 20 mg/day. The study medication will come in 10 mg and 25 mg tablet strengths.

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

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) - Treatment-emergent Adverse events (TEAE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.
Timepoint [1] 0 0
During the Evaluation Period (up to 9 years)
Primary outcome [2] 0 0
Percentage of Subjects Who Withdrew Due to Adverse Event (AE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) - Adverse Events (AE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.
Timepoint [2] 0 0
During the Evaluation Period (up to 9 years)
Primary outcome [3] 0 0
Percentage of Subjects With a Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) - An SAE was any untoward medical occurrence that, at any dose resulted in death, was life threatening, required in-subject hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Timepoint [3] 0 0
During the Evaluation Period (up to 9 years)
Secondary outcome [1] 0 0
Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 3 Months of the Evaluation Period (up to 9 Years) - BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
Timepoint [1] 0 0
During the Evaluation Period (up to 9 years)
Secondary outcome [2] 0 0
Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 6 Months, of the Evaluation Period (up to 9 Years) - BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
Timepoint [2] 0 0
During the Evaluation Period (up to 9 years)
Secondary outcome [3] 0 0
Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 12 Months of the Evaluation Period (up to 9 Years) - BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
Timepoint [3] 0 0
During the Evaluation Period (up to 9 years)

Eligibility
Key inclusion criteria
- Subjects with epilepsy who participated in previous brivaracetam trials which allow
access to the present trial.

- Subjects from whom the Investigator believes a reasonable potential benefit from the
long-term administration of brivaracetam may be expected.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Severe medical, neurological and psychiatric disorders, including current suicidal
ideation or behaviour, or laboratory values which may have an impact on the safety of the
subject, as determined by the investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
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
400 - Chatswood
Recruitment hospital [2] 0 0
404 - Adelaide
Recruitment hospital [3] 0 0
402 - Fitzroy
Recruitment hospital [4] 0 0
401 - Parkville
Recruitment postcode(s) [1] 0 0
- Chatswood
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Fitzroy
Recruitment postcode(s) [4] 0 0
- Parkville
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
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
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United States of America
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Ohio
Country [11] 0 0
United States of America
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Oklahoma
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United States of America
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Tennessee
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United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Vermont
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
West Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Belgium
State/province [19] 0 0
Gent
Country [20] 0 0
Belgium
State/province [20] 0 0
Kortrijk
Country [21] 0 0
Canada
State/province [21] 0 0
Alberta
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Czechia
State/province [23] 0 0
Brno
Country [24] 0 0
Czechia
State/province [24] 0 0
Litomysl
Country [25] 0 0
Czechia
State/province [25] 0 0
Ostava
Country [26] 0 0
Czechia
State/province [26] 0 0
Ostrava-Trebovice
Country [27] 0 0
Czechia
State/province [27] 0 0
Praha 4
Country [28] 0 0
France
State/province [28] 0 0
Bethune
Country [29] 0 0
France
State/province [29] 0 0
Toulouse Cedex 09
Country [30] 0 0
Germany
State/province [30] 0 0
Berlin
Country [31] 0 0
Germany
State/province [31] 0 0
Bernau
Country [32] 0 0
Germany
State/province [32] 0 0
Bielefeld
Country [33] 0 0
Germany
State/province [33] 0 0
Mainz
Country [34] 0 0
Germany
State/province [34] 0 0
Munchen
Country [35] 0 0
Germany
State/province [35] 0 0
Regensburg
Country [36] 0 0
Hungary
State/province [36] 0 0
Budapest
Country [37] 0 0
Italy
State/province [37] 0 0
Bergamo
Country [38] 0 0
Italy
State/province [38] 0 0
Messina
Country [39] 0 0
Italy
State/province [39] 0 0
Orbassano
Country [40] 0 0
Italy
State/province [40] 0 0
Perugia
Country [41] 0 0
Italy
State/province [41] 0 0
Pisa
Country [42] 0 0
Spain
State/province [42] 0 0
Madrid
Country [43] 0 0
Sweden
State/province [43] 0 0
Goteborg
Country [44] 0 0
Sweden
State/province [44] 0 0
Lund
Country [45] 0 0
Sweden
State/province [45] 0 0
Stockholm

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

Ethics approval
Ethics application status

Summary
Brief summary
The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16
years and older with epilepsy. This study permits continued access to treatment for subjects
who participated in a previous epilepsy study. The study will explore the long-term safety
and efficacy of brivaracetam.
Trial website
https://clinicaltrials.gov/show/NCT00761774
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
+1 844 599 2273(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
Other publications