Open-label Follow up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Aged 16 Years or Older Suffering From Epilepsy. - Full Text View

Purpose

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.

Condition	Intervention	Phase
Epilepsy	Drug: Brivaracetam	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Occurrence of at least one treatment-emergent adverse event during the Evaluation Period (approximately 10 years) [ Time Frame: From Entry visit 1 through the end of treatment (approximately 10 years) ] [ Designated as safety issue: No ]
Treatment-emergent adverse events are defined as adverse events with an onset date on or after the first study drug administration date.
Occurrence of discontinuations due to a treatment-emergent adverse event during the Evaluation Period (approximately 10 years). [ Time Frame: From Entry visit 1 through the end of treatment (approximately 10 years) ] [ Designated as safety issue: No ]
Treatment-emergent adverse events are defined as adverse events with an onset date on or after the first study drug administration date.

Secondary Outcome Measures:

For partial onset seizure (POS) subjects, Percent reduction from Baseline in Type 1 seizure frequency per 28 days over the Evaluation Period (up to maximum of 10 yrs). [ Time Frame: From baseline of original first study to maximum of 10 yrs ] [ Designated as safety issue: No ]
Baseline is the baseline from subject's original first study of enrollment period).

N01193-NCT00175825 N01252 NCT00490035 N01253- NCT00464269 N01254-NCT00504881 A 28-day Type I seizure frequency is the total number of Type I seizures divided by the total number of days evaluated multiplied by 28.
For Partial onset seizure (POS), Proportion of continuously seizure-free subjects for all seizure types (l+ll+lll) over the Evaluation Period (maximum of 10 yrs) [ Time Frame: From Entry visit 1 through the end of treatment (approximately 10 years) ] [ Designated as safety issue: No ]
Responder rate in partial onset seizure (POS) (Type l ) over the Evaluation Period. A responder is defined as a subject with an equal to or greater than 50 percent reduction in seizure frequency from the Baseline period of the prior study. [ Time Frame: From baseline of original first study to maximum of 10 yrs. ] [ Designated as safety issue: No ]
Baseline is the baseline from subject's original first study of enrollment Period).

N01193-NCT00175825 N01252 NCT00490035 N01253- NCT00464269 N01254-NCT00504881

Enrollment:	668
Study Start Date:	January 2006
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Brivaracetam Brivaracetam used as adjunctive treatment, Flexible dosing up to 200 mg /day in b.i.d administration. Dose increase or decrease can be made in increments of maximum 50 mg/day on a weekly basis.	Drug: Brivaracetam 10 mg and 25 mg tablets of brivarcacetam, flexible dosing up to a maximum of 200 mg given in b.i.d administration. The study will continue until a marketing authorization is granted by any Health Authority in an indication of adjunctive treatment in adults with refractory partial onset seizures (POS), whether or not secondarily generalized, until the Sponsor decides to close the study, or until brivaracetam development is stopped by the Sponsor.

Arms

Assigned Interventions

Experimental: Brivaracetam

Brivaracetam used as adjunctive treatment, Flexible dosing up to 200 mg /day in b.i.d administration. Dose increase or decrease can be made in increments of maximum 50 mg/day on a weekly basis.

Drug: Brivaracetam

10 mg and 25 mg tablets of brivarcacetam, flexible dosing up to a maximum of 200 mg given in b.i.d administration.

The study will continue until a marketing authorization is granted by any Health Authority in an indication of adjunctive treatment in adults with refractory partial onset seizures (POS), whether or not secondarily generalized, until the Sponsor decides to close the study, or until brivaracetam development is stopped by the Sponsor.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150800

Show 99 Study Locations

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00150800 History of Changes
Other Study ID Numbers:	N01199
Study First Received:	September 6, 2005
Last Updated:	May 23, 2013
Health Authority:	United States: Food and Drug Administration Brazil: National Committee of Ethics in Research Mexico: Ministry of Health India: Ministry of Health Canada: Health Canada Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by UCB, Inc.:

Brivaracetam
Epilepsy
partial onset seizures
open label

Additional relevant MeSH terms:

Epilepsy
Stress, Psychological
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 23, 2013