Brivaracetam
Drug- Pharmaceutical form: Solution for injection
- Concentration: 10 mg/ml
- Route of administration: Intravenous injection
Other names: Briviact
NCT Number: NCT03685630
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.
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Notify Me16 year and older
All sexes
Interventional
Phase 3
Ep0118 116, Asaka, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Briviact
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.
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.
Time frame: From study entry until Final Visit (up to 7 days)
A SAE must meet 1 or more of the following criteria:
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.
Time frame: Day 1
The plasma concentration level of brivaracetam 5 minutes postdose on Day 1.
Time frame: Day 2
The plasma concentration level of brivaracetam 5 minutes postdose on Day 2.
Time frame: Day 5
The plasma concentration level of brivaracetam 5 minutes postdose on Day 5.
UCB Biopharma S.P.R.L.
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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