- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03685630
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
April 12, 2021 updated by: UCB Biopharma S.P.R.L.
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Asaka, Japan
- Ep0118 116
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Bunkyo, Japan
- Ep0118 126
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Hamamatsu, Japan
- Ep0118 111
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Itami, Japan
- Ep0118 121
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Kamakura, Japan
- Ep0118 142
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Koshi, Japan
- Ep0118 112
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Shizuoka, Japan
- Ep0118 104
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Tsukuba, Japan
- Ep0118 138
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Yamagata, Japan
- Ep0118 109
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Brivaracetam
Subjects in this arm will receive open-label Brivaracetam.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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From study entry until Final Visit (up to 7 days)
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Subject withdrawal due to Adverse Events (AEs)
Time Frame: From study entry until Final Visit (up to 7 days)
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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.
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From study entry until Final Visit (up to 7 days)
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Occurrence of Serious Adverse Events (SAEs)
Time Frame: From study entry until Final Visit (up to 7 days)
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A SAE must meet 1 or more of the following criteria:
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From study entry until Final Visit (up to 7 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Partial seizure frequency during the Treatment Period
Time Frame: During the Treatment Period (from Day 1 to Day 5)
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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.
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During the Treatment Period (from Day 1 to Day 5)
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Brivaracetam (BRV) plasma concentration (at Day 1)
Time Frame: Day 1
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The plasma concentration level of brivaracetam 5 minutes postdose on Day 1.
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Day 1
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Brivaracetam (BRV) plasma concentration (at Day 2)
Time Frame: Day 2
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The plasma concentration level of brivaracetam 5 minutes postdose on Day 2.
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Day 2
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Brivaracetam (BRV) plasma concentration (at Day 5)
Time Frame: Day 5
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The plasma concentration level of brivaracetam 5 minutes postdose on Day 5.
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Day 5
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 4, 2019
Primary Completion (ACTUAL)
March 27, 2021
Study Completion (ACTUAL)
March 27, 2021
Study Registration Dates
First Submitted
September 20, 2018
First Submitted That Met QC Criteria
September 20, 2018
First Posted (ACTUAL)
September 26, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 13, 2021
Last Update Submitted That Met QC Criteria
April 12, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EP0118
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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