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A Study to Evaluate the Safety and Tolerability of Intravenous Brivaracetam (BRV) as Replacement for Oral Brivaracetam in Japanese Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

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ClinicalTrials.gov Identifier: NCT03685630
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : July 21, 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 safety and tolerability of intravenous (iv) brivaracetam (BRV) as adjunctive therapy administered as a replacement for oral BRV at doses ranging from BRV 50 mg/day to 200 mg/day in Japanese subjects >=16 years of age with partial seizures with or without secondary generalization and to evaluate the partial seizure frequency after switching from oral administration to iv BRV.

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
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Intravenous Brivaracetam as Replacement for Oral Brivaracetam in Japanese Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization
Actual Study Start Date : January 4, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arm Intervention/treatment
Experimental: Brivaracetam
Subjects in this arm will receive open-label Brivaracetam.
Drug: Brivaracetam
  • Pharmaceutical form: Solution for injection
  • Concentration: 10 mg/ml
  • Route of administration: Intravenous injection
Other Name: Briviact




Primary Outcome Measures :
  1. Adverse Events (AEs) as reported spontaneously by the subject or observed by the Investigator [ Time Frame: From study entry until Final Visit (up to 7 days) ]
    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.

  2. Subject withdrawal due to Adverse Events (AEs) [ Time Frame: From study entry until Final Visit (up to 7 days) ]
    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.

  3. Occurrence of Serious Adverse Events (SAEs) [ Time Frame: From study entry until Final Visit (up to 7 days) ]

    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


Secondary Outcome Measures :
  1. Partial seizure frequency during the Treatment Period [ Time Frame: During the Treatment Period (from Day 1 to Day 5) ]
    Partial Seizures can be classified into one of the following three groups: Simple Partial Seizures, Complex Partial Seizures, Partial Seizures evolving to Secondarily Generalized Seizures. The partial seizure frequency will be assessed using the seizure count information recorded on the daily record card (DRC). The written information will be discussed with the subject in order to ensure completeness and accuracy. As a result of the discussion, the Investigator will assess the seizures according to the International League Against Epilepsy (ILAE) codes and record the seizure types and frequency on the DRC.

  2. Brivaracetam (BRV) plasma concentration (at Day 1) [ Time Frame: Day 1 ]
    The plasma concentration level of brivaracetam 5 minutes postdose on Day 1.

  3. Brivaracetam (BRV) plasma concentration (at Day 2) [ Time Frame: Day 2 ]
    The plasma concentration level of brivaracetam 5 minutes postdose on Day 2.

  4. Brivaracetam (BRV) plasma concentration (at Day 5) [ Time Frame: Day 5 ]
    The plasma concentration level of brivaracetam 5 minutes postdose on Day 5.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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:

  • Subject has, in the opinion of the Investigator, adequate seizure control for participation in the study, and is willing and able to comply with all study requirements including hospitalization, multiple blood draws, and intravenous (iv) injection
  • Female subjects without childbearing potential (postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
  • Japanese subject is currently enrolled in EP0085 [NCT03250377] receiving oral brivaracetam (BRV) for the treatment of partial seizures and has been enrolled for at least 8 weeks prior to entry into EP0118
  • Subject has been on a stable twice daily dosage regimen of BRV 50 mg/day to 200 mg/day for the 4 weeks prior to entry into EP0118
  • Subject has been receiving concomitant antiepileptic drug (AED(s)) at doses that have remained stable for the 4 weeks (12 weeks for phenobarbital, phenytoin, and primidone) prior to entry into EP0118
  • Subject has been receiving drugs with possible central nervous system (CNS) effects at doses that have remained stable for the 4 weeks prior to entry into EP0118, if applicable
  • Subject has been receiving drugs that significantly influence the metabolism of BRV at doses that have remained stable for the 4 weeks prior to entry into EP0118, if applicable
  • Subject has had stable vagal nerve stimulation (VNS) settings for the 4 weeks prior to entry into EP0118, if applicable

Exclusion Criteria:

  • Subject is receiving an investigational medicinal product (IMP) or unapproved medication other than oral BRV, or using an experimental medical device
  • Subject has previously been treated with intravenous (iv) brivaracetam (BRV)
  • Subject has a known hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol
  • Subject has a confirmed clinically relevant abnormality by electrocardiogram (ECG)
  • Subject has a severe medical, neurological, or psychiatric disorder, or abnormal laboratory values which may have an impact on the safety of the subject
  • Subject has demonstrated poor compliance with the visit schedule or medication intake in previous BRV studies
  • Subject has planned participation in any other clinical study of another IMP or device during this study
  • Subject is a pregnant or lactating female
  • Subject has any medical condition which, in the Investigator's opinion, warrants exclusion
  • Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) "Since Last Visit" at Screening
  • Subject has >2x upper limit of normal (ULN) of any of the following prior to Day 1 (from liver function assessment in EP0085): 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): NCT03685630


Contacts
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Contact: UCB Cares 001844599 ext 2273 UCBCares@ucb.com

Locations
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Japan
Ep0118 116 Recruiting
Asaka, Japan
Ep0118 111 Recruiting
Hamamatsu, Japan
Ep0118 121 Recruiting
Itami, Japan
Ep0118 112 Recruiting
Koshi, Japan
Ep0118 104 Recruiting
Shizuoka, Japan
Ep0118 109 Recruiting
Yamagata, Japan
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: NCT03685630    
Other Study ID Numbers: EP0118
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 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
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Brivaracetam
Epilepsy
Partial seizures with or without secondary generalization
Japanese subjects
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Epilepsy
Seizures
Neoplastic Processes
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Brivaracetam
Anticonvulsants