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

Purpose

This trial, evaluating the long-term safety and tolerability of brivaracetam, will give subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity to continue the treatment. The study will also evaluate the maintenance of efficacy over time of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures (PGS).

Condition	Intervention	Phase
Epilepsy	Drug: Brivaracetam (ucb 34714)	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, Multicenter, 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 study (over a maximum 11 years) [ Time Frame: From entry visit 1 up to maximum 11 years ] [ Designated as safety issue: No ]
Occurrence of at least one treatment-emergent drug related adverse event during the study (over a maximum 11 years) [ Time Frame: From entry visit 1 up to maximum 11 years ] [ Designated as safety issue: No ]
Occurrence of discontinuations due to a treatment-emergent adverse event (over maximum 11 years) [ Time Frame: From entry visit 1 up to maximum 11 years ] [ Designated as safety issue: No ]
Occurrence of at least one serious adverse event during the study (over maximum 11 years) [ Time Frame: From entry visit 1 up to maximum 11 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

For subjects with focal-onset epilepsy, partial onset seizure (type I) frequency per 28 days during the evaluation period (maximum 11 years) [ Time Frame: From entry visit 1 up to maximum of 11 years ] [ Designated as safety issue: No ]
a 28-day type I seizure frequency is the total number of type I seizures divided by the total number of days multiplied by 28
For subjects with focal-onset epilepsy, percent reduction in partial onset seizure (type I) frequency per 28 days from baseline of the previous study through the evaluation period (maximum 11 years) [ Time Frame: From entry visit 1 up to maximum of 11 years ] [ Designated as safety issue: No ]
baseline is the baseline from subject original first study of enrollment( N01114 - NCT00175929 N01252 - NCT00490035 N01254 - NCT00504881)

a 28-day type I seizure frequency is the total number of type I seizures divided by the total number of days multiplied by 28
For subjects with focal-onset epilepsy, responder rate for partial onset seizure (Type I) frequency over the evaluation period (maximum 11 years [ Time Frame: From entry visit 1 up to maximum of 11 years ] [ Designated as safety issue: No ]
baseline is the baseline from subject original first study of enrollment N01114 - NCT00175929 N01252 - NCT00490035 N01254 - NCT00504881 a responder is defined as a subject with a ≥50% reduction in seizure frequency from baseline

Enrollment:	853
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Brivaracetam Flexible dosing, can up and down titrate as needed.	Drug: Brivaracetam (ucb 34714) 10 mg and 25 mg tablets. Flexible dosing up to 200 mg/day, twice daily. The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor.

Arms

Assigned Interventions

Experimental: Brivaracetam

Flexible dosing, can up and down titrate as needed.

Drug: Brivaracetam (ucb 34714)

10 mg and 25 mg tablets. Flexible dosing up to 200 mg/day, twice daily. The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product 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 (where legally permitted and ethically accepted) or 18 years onwards suffering from epilepsy and having completed a previous study with brivaracetam as adjunctive treatment, which allowed access to this study
Subjects with POS/PGS: inpatients or outpatients with epilepsy who participated in previous brivaracetam studies / programs which allow access to the present study
Subjects with ULD: inpatients or outpatients with epilepsy who were treated with brivaracetam in previous studies / programs 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

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 visit schedule or medication intake in previous brivaracetam study
Participation in any clinical study of another investigational drug or device during the study
Pregnant or lactating woman

Contacts and Locations

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

Show 153 Study Locations

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493

More Information

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00175916 History of Changes
Other Study ID Numbers:	N01125, 2004-002140-10
Study First Received:	September 9, 2005
Last Updated:	April 24, 2013
Health Authority:	Austria: Federal Ministry for Health and Women Belgium: Federal Agency for Medicines and Health Products, FAMHP Czech Republic: State Institute for Drug Control Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Italy: The Italian Medicines Agency Israel: Israeli Health Ministry Pharmaceutical Administration Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Norway: Norwegian Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health of the Russian Federation Serbia and Montenegro: Agency for Drugs and Medicinal Devices South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Switzerland: Swissmedic Tunisia: Ministry of Public Health Ukraine: Ministry of Health Canada: Health Canada United States: Food and Drug Administration Hong Kong: Department of Health Singapore: Health Sciences Authority South Korea: Korea Food and Drug Administration (KFDA) Taiwan : Food and Drug Administration

Keywords provided by UCB, Inc.:

Brivaracetam
Epilepsy
long term

Additional relevant MeSH terms:

Epilepsy
Stress, Psychological
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on June 18, 2013