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Trial record 1 of 1 for:    NCT03250377
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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 : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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.

Condition or disease Intervention/treatment Phase
Partial Seizures With or Without Secondary Generalization Epilepsy Drug: Brivaracetam Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 227 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 5, 2017
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
Experimental: Brivaracetam
Subjects randomized to this arm will receive open-label Brivaracetam
Drug: Brivaracetam
  • Pharmaceutical form: Film-coated tablet
  • Concentration: 25 mg and 50 mg
  • Route of administration: Oral use
Other Name: Briviact




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250377


Locations
Show Show 32 study locations
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)

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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03250377    
Other Study ID Numbers: EP0085
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Brivaracetam
Epilepsy
Partial seizures with or without secondary generalization
Briviact
Additional relevant MeSH terms:
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Neoplasm Metastasis
Epilepsy
Seizures
Neoplastic Processes
Neoplasms
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Brivaracetam
Anticonvulsants