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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00175916
First received: September 9, 2005
Last updated: August 28, 2014
Last verified: August 2014
  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:


Further study details as provided by UCB Pharma:

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: January 2017
Estimated Primary Completion Date: January 2017 (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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 153 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00175916     History of Changes
Other Study ID Numbers: N01125, 2004-002140-10
Study First Received: September 9, 2005
Last Updated: August 28, 2014
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 Pharma:
Brivaracetam
Epilepsy
long term

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014