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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00150800




Registration number
NCT00150800
Ethics application status
Date submitted
6/09/2005
Date registered
8/09/2005
Date last updated
5/12/2018

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 - 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.
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 - 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.
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 - A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.
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 - 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.
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 - 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.
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 - 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.
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
Gender
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
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
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
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United States of America
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Arizona
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Arkansas
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California
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Georgia
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Illinois
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Kansas
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Kentucky
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Louisiana
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Maryland
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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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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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Florianopolis
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Florianópolis
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Porto Alegre
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Brazil
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Riberao Preto
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Salvador
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Sao Paulo
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São José do Rio Preto
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Quebec
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India
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Maharashti
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Bangalore
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Chennai
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Hyderabad
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Jaipur
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Lucknow
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Mumbai
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Parel Mumbai
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Pune Maharashtra
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Pune
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India
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Tirupati
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Chihuahua
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Mexico City
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Monterrey
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San Luis Potosi
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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/show/NCT00150800
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