Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03250377
Recruitment Status : Enrolling by invitation
First Posted : August 15, 2017
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Tracking Information
First Submitted Date  ICMJE July 31, 2017
First Posted Date  ICMJE August 15, 2017
Last Update Posted Date August 7, 2020
Actual Study Start Date  ICMJE August 5, 2017
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2019)
Adverse Events (AEs) [ Time Frame: From study entry until Final Visit (up to 70 months) ]
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
  • Number of subjects with Adverse Events (AEs) during the study [ Time Frame: From study entry until Final Visit (up to 70 months) ]
    An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
  • Number of subjects who withdraw from the study due to Adverse Events (AEs) [ Time Frame: From study entry until Final Visit (up to 70 months) ]
    An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
  • Number of subjects with Serious Adverse Events (SAEs) during the study [ Time Frame: From study entry until Final Visit (up to 70 months) ]
    A SAE must meet 1 or more of the following criteria:
    • Death
    • Life-threatening
    • Significant or persistent disability/incapacity
    • Congenital anomaly/birth defect
    • Initial inpatient hospitalization or prolongation of hospitalization
    • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Percent change in partial seizure frequency per 28 days from Baseline of EP0083 or N01358 to the Evaluation Period [ Time Frame: Baseline of EP0083 or N01358 and by 3-month periods over the Evaluation Period (up to 70 months) ]
    The seizure frequency is calculated as number of seizures per 28 days. This evaluation will be done every 3 months of the Evaluation Period (by 3-month periods). Change in seizure frequency from Baseline of EP0083 (NCT03083665) or N01358 (NCT01261325) is calculated as the seizure frequency at the evaluation time point minus the seizure frequency at Baseline of EP0083 or N01358.
  • Responder rate in partial seizure frequency per 28 days over the Evaluation Period [ Time Frame: Baseline of EP0083 or N01358 and by 3-month periods over the Evaluation Period (up to 70 months) ]
    The seizure frequency is calculated as number of seizures per 28 days. This evaluation will be done every 3 months of the Evaluation Period (by 3-month periods). A responder is defined as a subject with a >= 50% reduction in seizure frequency from the Baseline Period of EP0083 or N01358.
  • Percentage of subjects continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 6 months during the Evaluation Period [ Time Frame: During the Evaluation Period (up to 70 months) ]
    A subject was considered seizure free, if no seizure occurred during 6 consecutive months in the Evaluation Period.
  • Percentage of subjects continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 12 months during the Evaluation Period [ Time Frame: During the Evaluation Period (up to 70 months) ]
    A subject was considered seizure free, if no seizure occurred during 12 consecutive months in the Evaluation Period.
  • Percentage of subjects continuously seizure-free for partial seizure and all seizure types during the Evaluation Period [ Time Frame: During the Evaluation Period (up to 70 months) ]
    A subject was considered seizure free (partial, all epileptic seizure), if no seizure occurred during the Evaluation Period.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
  • Percent change in partial seizure frequency per 28 days from Baseline of EP0083 or N01358 by 3-month periods over the Evaluation Period [ Time Frame: Baseline of EP0083 or N01358 and by 3-month periods over the Evaluation Period (up to 70 months) ]
    The seizure frequency is calculated as number of seizures per 28 days. This evaluation will be done every 3 months over the Evaluation Period. Percent change in seizure frequency from Baseline of EP0083 (NCT03083665) or N01358 (NCT01261325) is calculated from the seizure frequency during the 3-month period and that at Baseline of EP0083 or N01358.
  • Responder rate in partial seizure frequency per 28 days by 3-month periods over the Evaluation Period [ Time Frame: Baseline of EP0083 or N01358 and by 3-month periods over the Evaluation Period (up to 70 months) ]
    The seizure frequency is calculated as number of seizures per 28 days. This evaluation will be done every 3 months over the Evaluation Period. A responder is defined as a subject with a >= 50% reduction in seizure frequency from the Baseline Period of EP0083 or N01358.
  • Percentage of subjects continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 6 months during the Evaluation Period [ Time Frame: During the Evaluation Period (up to 70 months) ]
    A subject was considered seizure free, if no seizure occurred during 6 consecutive months in the Evaluation Period.
  • Percentage of subjects continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 12 months during the Evaluation Period [ Time Frame: During the Evaluation Period (up to 70 months) ]
    A subject was considered seizure free, if no seizure occurred during 12 consecutive months in the Evaluation Period.
  • Number of subjects with abnormal findings in laboratory tests [ Time Frame: By 3-month periods over the Evaluation Period (up to 70 months) ]
    Safety will be assessed by number of subjects with abnormal findings in laboratory tests (blood chemistry, hematology, and urinalysis).
  • Number of subjects with abnormal findings in vital signs [ Time Frame: By 3-month periods over the Evaluation Period (up to 70 months) ]
    Safety will be assessed by number of subjects with abnormal findings in vital signs.
  • Number of subjects with abnormal findings in body weight [ Time Frame: By 3-month periods over the Evaluation Period (up to 70 months) ]
    Safety will be assessed by number of subjects with abnormal findings in body weight.
  • Number of subjects with abnormal findings in 12-lead electrocardiogram (ECG) [ Time Frame: By 3-month periods over the Evaluation Period (up to 70 months) ]
    Safety will be assessed by number of subjects with abnormal findings in 12-lead electrocardiogram (ECG)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization
Official Title  ICMJE An Open-Label, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization
Brief Summary The purpose of the study is to evaluate the long-term safety and tolerability of Brivaracetam (BRV) in focal epilepsy subjects with partial seizures and to evaluate the maintenance of efficacy of BRV over time.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Partial Seizures With or Without Secondary Generalization
  • Epilepsy
Intervention  ICMJE Drug: Brivaracetam
  • Pharmaceutical form: Film-coated tablet
  • Concentration: 25 mg and 50 mg
  • Route of administration: Oral use
Other Name: Briviact
Study Arms  ICMJE Experimental: Brivaracetam
Subjects randomized to this arm will receive open-label Brivaracetam
Intervention: Drug: Brivaracetam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: April 9, 2019)
227
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2017)
124
Estimated Study Completion Date  ICMJE February 2025
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male/female subject from 16 years of age or older. Subjects who are not legal adults may only be included where legally permitted and ethically accepted
  • Subject completed the Treatment Period and Transition Period of EP0083 or is ongoing in N01379 sites in Japan
  • Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method

Exclusion Criteria:

  • Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core study
  • Severe medical, neurological or 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 BRV studies
  • Planned participation in any other clinical study of another investigational drug or device during this study
  • Pregnant or lactating woman
  • Any medical condition which, in the Investigator's opinion, warrants exclusion
  • Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
  • Subject has >2 x upper limit of normal (ULN) of any of the following at the Entry Visit (EV): alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (≥1.5x ULN total bilirubin if known Gilbert's syndrome)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03250377
Other Study ID Numbers  ICMJE EP0085
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party UCB Pharma ( UCB Biopharma S.P.R.L. )
Study Sponsor  ICMJE UCB Biopharma S.P.R.L.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Cares 001 844 599 2273 (UCB)
PRS Account UCB Pharma
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP