Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB PHARMA Inc. (US) )
ClinicalTrials.gov Identifier:
NCT00150800
First received: September 6, 2005
Last updated: November 17, 2016
Last verified: November 2016
  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:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Incidence of at least one Treatment-Emergent Adverse Event (TEAE) during the Evaluation Period [ Time Frame: Visit 1 through last Evaluation Period (up to 11 years) ] [ Designated as safety issue: No ]
    Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.

  • Incidence of subjects who withdraw due to an Adverse Event (AE) during the Evaluation Period [ Time Frame: Visit 1 through the last Evaluation Period (up to 11 years) ] [ Designated as safety issue: No ]
    Adverse Events (AE) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.

  • Incidence of a Serious Adverse Event (SAE) during the Evaluation Period [ Time Frame: Visit 1 through the last Evaluation Period (up to 11 years) ] [ Designated as safety issue: No ]
    A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.


Secondary Outcome Measures:
  • Partial Onset Seizure (POS) (type I) frequency per 28 days during the Evaluation Period [ Time Frame: From Baseline of the previous study to the Evaluation Period (up to 11 years) ] [ Designated as safety issue: No ]

    Baseline is the Baseline from subject's previous study of enrollment period. N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254 [NCT00504881].

    A 28 day Type 1 seizure frequency is the total number of Type 1 seizures divided by the total number of days evaluated multiplied by 28.


  • Percent reduction in Partial Onset Seizure (POS) (type I) frequency per 28 days from Baseline of the previous study to the Evaluation Period [ Time Frame: From Baseline of previous study( up to 11 years) ] [ Designated as safety issue: No ]

    Baseline is the Baseline from subject's previous study of enrollment period. N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254 [NCT00504881].

    A 28 day Type 1 seizure frequency is the total number of Type 1 seizures divided by the total number of days evaluated multiplied by 28.


  • Responder rate for Partial Onset Seizure (POS) (type I) frequency over the Evaluation Period [ Time Frame: From Baseline of previous study (up to 11 years) ] [ Designated as safety issue: No ]
    Responder rate for POS ( type 1) frequency over the Evaluation Period. A responder is defined as a subject with a -≥ 50 % reduction in seizure frequency from Baseline period of the previous study.


Enrollment: 668
Study Start Date: January 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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 (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg/day on a weekly basis.
Drug: Brivaracetam
  • Active Substance: Brivaracetam
  • Pharmaceutical Form: Tablet
  • Concentration: 10 mg and 25 mg
  • Route of Administration: Oral

  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
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
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: NCT00150800

  Show 99 Study Locations
Sponsors and Collaborators
UCB PHARMA Inc. (US)
Investigators
Study Director: UCB Cares +1 877 822 9493 (UCB)
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB PHARMA Inc. (US)
ClinicalTrials.gov Identifier: NCT00150800     History of Changes
Other Study ID Numbers: N01199 
Study First Received: September 6, 2005
Last Updated: November 17, 2016
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 Pharma:
Brivaracetam
Epilepsy
Partial Onset Seizures
open label

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

ClinicalTrials.gov processed this record on December 06, 2016