Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00150800
Registration number
NCT00150800
Ethics application status
Date submitted
6/09/2005
Date registered
8/09/2005
Date last updated
17/08/2021
Titles & IDs
Public title
This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment
Query!
Scientific title
An Open-label, Multi-center, Follow-up Trial to Evaluate Long Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy
Query!
Secondary ID [1]
0
0
N01199
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Epilepsy
0
0
Query!
Condition category
Condition code
Neurological
0
0
0
0
Query!
Epilepsy
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Brivaracetam
Experimental: Brivaracetam - Brivaracetam used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg/day on a weekly basis.
Treatment: Drugs: Brivaracetam
* Active Substance: Brivaracetam
* Pharmaceutical Form: Tablet
* Concentration: 10 mg and 25 mg
* Route of Administration: Oral
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period
Query!
Assessment method [1]
0
0
Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Query!
Timepoint [1]
0
0
Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Query!
Primary outcome [2]
0
0
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period
Query!
Assessment method [2]
0
0
Adverse Events (AE) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Query!
Timepoint [2]
0
0
Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Query!
Primary outcome [3]
0
0
Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period
Query!
Assessment method [3]
0
0
A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.
Query!
Timepoint [3]
0
0
Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Query!
Secondary outcome [1]
0
0
Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
Query!
Assessment method [1]
0
0
Baseline is the Baseline from subject's previous study of enrollment period. N01193 \[NCT00175825\], N01252 \[NCT00490035\], N01253 \[NCT00464269\], N01254 \[NCT00504881\].
A 28 day Type 1 seizure frequency is the total number of Type 1 seizures divided by the total number of days evaluated multiplied by 28.
Query!
Timepoint [1]
0
0
From Baseline of the previous study to the Evaluation Period (up to 11 years)
Query!
Secondary outcome [2]
0
0
Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period
Query!
Assessment method [2]
0
0
The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as:
(the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines.
Query!
Timepoint [2]
0
0
From Baseline of the previous study to the Evaluation Period (up to 11 years)
Query!
Secondary outcome [3]
0
0
Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period
Query!
Assessment method [3]
0
0
A responder is defined as a subject with a higher than or equal to (\>=) 50 % change in seizure frequency from Baseline period of the previous study.
Query!
Timepoint [3]
0
0
From Baseline of the previous study to the Evaluation Period (up to 11 years)
Query!
Eligibility
Key inclusion criteria
* Male/ female subjects from 16 years and on. Subjects under 18 years may only be included where legally permitted and ethically accepted
* Subjects with epilepsy who have participated in previous brivaracetam trials which allow access to the present study
* Subjects for whom the investigator believes a reasonable benefit from the long term administration of brivaracetam may be expected
* Female subjects without childbearing potential. Female subjects with child bearing potential are eligible if they use a medically accepted contraceptive method for the duration of the study
* Subject/ legally acceptable representative considered as reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the Investigator
Query!
Minimum age
16
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Severe medical, neurological and psychiatric disorders or laboratory values which may have an impact on the safety of the subject
* Poor compliance with the visit schedule or medication intake in the previous brivaracetam study
* Pregnant or lactating women
* Participation in any clinical study of another investigational drug or device during the study
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/01/2006
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/09/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
668
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Query!
Recruitment hospital [1]
0
0
N01199 1420 - Chatswood
Query!
Recruitment hospital [2]
0
0
N01199 1430 - Randwick
Query!
Recruitment hospital [3]
0
0
N01199 1423 - Adelaide
Query!
Recruitment hospital [4]
0
0
N01199 1428 - Woodville
Query!
Recruitment hospital [5]
0
0
N01199 1427 - Clayton
Query!
Recruitment hospital [6]
0
0
N01199 1426 - Parkville
Query!
Recruitment hospital [7]
0
0
N01199 1421 - West Heidelberg
Query!
Recruitment hospital [8]
0
0
N01199 1422 - Fitzroy
Query!
Recruitment postcode(s) [1]
0
0
- Chatswood
Query!
Recruitment postcode(s) [2]
0
0
- Randwick
Query!
Recruitment postcode(s) [3]
0
0
- Adelaide
Query!
Recruitment postcode(s) [4]
0
0
- Woodville
Query!
Recruitment postcode(s) [5]
0
0
- Clayton
Query!
Recruitment postcode(s) [6]
0
0
- Parkville
Query!
Recruitment postcode(s) [7]
0
0
- West Heidelberg
Query!
Recruitment postcode(s) [8]
0
0
- Fitzroy
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Kansas
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kentucky
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Louisiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Minnesota
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Mississippi
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Missouri
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Montana
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New Jersey
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New York
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Ohio
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Oregon
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Pennsylvania
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
South Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Tennessee
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Texas
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Utah
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Virginia
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Washington
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Wisconsin
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Campinas
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Curitiba
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
Florianopolis
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Florianópolis
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
Porto Alegre
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
Riberao Preto
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
Salvador
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
Sao Paulo
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
São José do Rio Preto
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Alberta
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Quebec
Query!
Country [39]
0
0
India
Query!
State/province [39]
0
0
Maharashti
Query!
Country [40]
0
0
India
Query!
State/province [40]
0
0
Bangalore
Query!
Country [41]
0
0
India
Query!
State/province [41]
0
0
Chennai
Query!
Country [42]
0
0
India
Query!
State/province [42]
0
0
Hyderabad
Query!
Country [43]
0
0
India
Query!
State/province [43]
0
0
Jaipur
Query!
Country [44]
0
0
India
Query!
State/province [44]
0
0
Lucknow
Query!
Country [45]
0
0
India
Query!
State/province [45]
0
0
Mumbai
Query!
Country [46]
0
0
India
Query!
State/province [46]
0
0
Parel Mumbai
Query!
Country [47]
0
0
India
Query!
State/province [47]
0
0
Pune Maharashtra
Query!
Country [48]
0
0
India
Query!
State/province [48]
0
0
Pune
Query!
Country [49]
0
0
India
Query!
State/province [49]
0
0
Tirupati
Query!
Country [50]
0
0
Mexico
Query!
State/province [50]
0
0
Nuevo Leon
Query!
Country [51]
0
0
Mexico
Query!
State/province [51]
0
0
Aguascalientes
Query!
Country [52]
0
0
Mexico
Query!
State/province [52]
0
0
Chihuahua
Query!
Country [53]
0
0
Mexico
Query!
State/province [53]
0
0
Guadalajara
Query!
Country [54]
0
0
Mexico
Query!
State/province [54]
0
0
Mexico City
Query!
Country [55]
0
0
Mexico
Query!
State/province [55]
0
0
Monterrey
Query!
Country [56]
0
0
Mexico
Query!
State/province [56]
0
0
San Luis Potosi
Query!
Country [57]
0
0
Mexico
Query!
State/province [57]
0
0
Zapopan
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
UCB PHARMA Inc. (US)
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This trial, evaluating the long-term safety and tolerability of brivaracetam will provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00150800
Query!
Trial related presentations / publications
O'Brien TJ, Borghs S, He QJ, Schulz AL, Yates S, Biton V. Long-term safety, efficacy, and quality of life outcomes with adjunctive brivaracetam treatment at individualized doses in patients with epilepsy: An up to 11-year, open-label, follow-up trial. Epilepsia. 2020 Apr;61(4):636-646. doi: 10.1111/epi.16484. Epub 2020 Mar 28. Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24. Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
UCB Cares
Query!
Address
0
0
+1 844 599 2273 (UCB)
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/00/NCT00150800/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/00/NCT00150800/SAP_001.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
O'Brien TJ, Borghs S, He QJ, Schulz AL, Yates S, B...
[
More Details
]
Journal
Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asad...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00150800
Download to PDF