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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
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
Secondary ID [1] 0 0
N01199
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 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period
Timepoint [1] 0 0
Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Primary outcome [2] 0 0
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period
Timepoint [2] 0 0
Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Primary outcome [3] 0 0
Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period
Timepoint [3] 0 0
Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Secondary outcome [1] 0 0
Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
Timepoint [1] 0 0
From Baseline of the previous study to the Evaluation Period (up to 11 years)
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
Timepoint [2] 0 0
From Baseline of the previous study to the Evaluation Period (up to 11 years)
Secondary outcome [3] 0 0
Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period
Timepoint [3] 0 0
From Baseline of the previous study to the Evaluation Period (up to 11 years)

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
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2017
Sample size
Target
Accrual to date
Final
668
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
N01199 1420 - Chatswood
Recruitment hospital [2] 0 0
N01199 1430 - Randwick
Recruitment hospital [3] 0 0
N01199 1423 - Adelaide
Recruitment hospital [4] 0 0
N01199 1428 - Woodville
Recruitment hospital [5] 0 0
N01199 1427 - Clayton
Recruitment hospital [6] 0 0
N01199 1426 - Parkville
Recruitment hospital [7] 0 0
N01199 1421 - West Heidelberg
Recruitment hospital [8] 0 0
N01199 1422 - Fitzroy
Recruitment postcode(s) [1] 0 0
- Chatswood
Recruitment postcode(s) [2] 0 0
- Randwick
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Woodville
Recruitment postcode(s) [5] 0 0
- Clayton
Recruitment postcode(s) [6] 0 0
- Parkville
Recruitment postcode(s) [7] 0 0
- West Heidelberg
Recruitment postcode(s) [8] 0 0
- Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
Arkansas
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United States of America
State/province [3] 0 0
California
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United States of America
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Georgia
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United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
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United States of America
State/province [7] 0 0
Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Montana
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New Jersey
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New York
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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United States of America
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Wisconsin
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Brazil
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Campinas
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Brazil
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Curitiba
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Brazil
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Florianopolis
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Brazil
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Florianópolis
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Brazil
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Porto Alegre
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Brazil
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Riberao Preto
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Brazil
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Salvador
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Brazil
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Sao Paulo
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Brazil
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São José do Rio Preto
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Canada
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Alberta
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Canada
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Quebec
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India
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Maharashti
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India
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Bangalore
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India
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Chennai
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India
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Hyderabad
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India
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Jaipur
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India
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Lucknow
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India
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Mumbai
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India
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Parel Mumbai
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India
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Pune Maharashtra
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India
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Pune
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India
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Tirupati
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Mexico
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Nuevo Leon
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Aguascalientes
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Chihuahua
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Guadalajara
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Mexico City
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Mexico
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Monterrey
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Mexico
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San Luis Potosi
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Mexico
State/province [57] 0 0
Zapopan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB PHARMA Inc. (US)
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00150800
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.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00150800