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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
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
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
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Montana
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Utah
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
United States of America
State/province [27] 0 0
Wisconsin
Country [28] 0 0
Brazil
State/province [28] 0 0
Campinas
Country [29] 0 0
Brazil
State/province [29] 0 0
Curitiba
Country [30] 0 0
Brazil
State/province [30] 0 0
Florianopolis
Country [31] 0 0
Brazil
State/province [31] 0 0
Florianópolis
Country [32] 0 0
Brazil
State/province [32] 0 0
Porto Alegre
Country [33] 0 0
Brazil
State/province [33] 0 0
Riberao Preto
Country [34] 0 0
Brazil
State/province [34] 0 0
Salvador
Country [35] 0 0
Brazil
State/province [35] 0 0
Sao Paulo
Country [36] 0 0
Brazil
State/province [36] 0 0
São José do Rio Preto
Country [37] 0 0
Canada
State/province [37] 0 0
Alberta
Country [38] 0 0
Canada
State/province [38] 0 0
Quebec
Country [39] 0 0
India
State/province [39] 0 0
Maharashti
Country [40] 0 0
India
State/province [40] 0 0
Bangalore
Country [41] 0 0
India
State/province [41] 0 0
Chennai
Country [42] 0 0
India
State/province [42] 0 0
Hyderabad
Country [43] 0 0
India
State/province [43] 0 0
Jaipur
Country [44] 0 0
India
State/province [44] 0 0
Lucknow
Country [45] 0 0
India
State/province [45] 0 0
Mumbai
Country [46] 0 0
India
State/province [46] 0 0
Parel Mumbai
Country [47] 0 0
India
State/province [47] 0 0
Pune Maharashtra
Country [48] 0 0
India
State/province [48] 0 0
Pune
Country [49] 0 0
India
State/province [49] 0 0
Tirupati
Country [50] 0 0
Mexico
State/province [50] 0 0
Nuevo Leon
Country [51] 0 0
Mexico
State/province [51] 0 0
Aguascalientes
Country [52] 0 0
Mexico
State/province [52] 0 0
Chihuahua
Country [53] 0 0
Mexico
State/province [53] 0 0
Guadalajara
Country [54] 0 0
Mexico
State/province [54] 0 0
Mexico City
Country [55] 0 0
Mexico
State/province [55] 0 0
Monterrey
Country [56] 0 0
Mexico
State/province [56] 0 0
San Luis Potosi
Country [57] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT00150800