Follow-up Trial to Evaluate Long-Term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00175916

Purpose

This trial, evaluating the long-term safety and tolerability of brivaracetam and the maintenance of efficacy over time, will give subjects suffering from partial onset seizures, who may have benefited from brivaracetam the opportunity to continue the treatment.

Condition	Intervention	Phase
Epilepsy, Partial	Drug: Brivaracetam (ucb 34714)	Phase III

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	An Open-Label, Multicenter, Follow-up Trial to Evaluate Long-Term Safety and Efficacy of Ucb 34714 Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 150 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy

Further study details as provided by UCB:

Primary Outcome Measures:

Evaluate the long-term safety and tolerability of brivaracetam at individualized doses with a maximum of 150 mg/day in subjects suffering from epilepsy. [ Time Frame: This long tern follow up will end when approval of brivaracetam has been obtained in the EU or until the investigational product development is stopped. ]

Secondary Outcome Measures:

To evaluate the maintenance of efficacy over time of brivaracetam. [ Time Frame: This long tern follow up will end when approval of brivaracetam has been obtained in the EU or until the investigational product development is stopped. ]

Estimated Enrollment:	1000
Study Start Date:	September 2005
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Flexible dosing, can up and down titrate as needed.	Drug: Brivaracetam (ucb 34714) 2.5mg, 10mg, 25mg tablets. Flexible dosing up to 150mg/day in BID administration. Until approval in EU is obtained or when investigational product development is stopped.

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 or older. Subjects under 18 years may only be included where legally permitted and ethically accepted.
Inpatients or outpatients with partial onset seizures who were treated with ucb 34714 in previous trials / programs which allow access to the present trial.
Subjects for whom the Investigator believes a reasonable benefit from the long-term administration of ucb 34714 may be expected.

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175916

Show 122 Study Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	N01125, EudraCT 2004-002140-10
Study First Received:	September 9, 2005
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00175916
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; Czech Republic: State Institute for Drug Control; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Netherlands: Medicines Evaluation Board (MEB); Poland: Ministry of Health; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Austria: Federal Ministry for Health and Women; Norway: Norwegian Medicines Agency; Singapore: Health Sciences Authority; Turkey: Ministry of Health; Switzerland: Swissmedic; Italy: Ministry of Health

Keywords provided by UCB:

Epilepsy: partial onset seizures,
brivaracetam.

Study placed in the following topic categories:

Epilepsies, Partial
Epilepsy
Seizures
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009