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Tests treatment safety and results for Epilepsy
Official title A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
ClinicalTrials.gov ID: NCT04715646
What this study is testing
What is Brivaracetam?
Brivaracetam is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for epilepsy.
Also referred to as BRV, Briviact.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 and older
You may be able to join if
- for long-term follow-up (LTFU) study participants only
- Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 [NCT01364597] and/or N01349...
- Study participant is ≥ 4 years to \< 16 years of age
- Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years
- Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment with at least 1 antiepileptic drug (AED)
You likely can't join if
- Exclusion criteria for all study participants
- Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant
- Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV)...
- Study participant has a history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures
- Study participant has a history of status epilepticus in the 30 days prior to the Screening Visit (ScrV) or during the Screening Period
- Study participant has any clinically significant illness
See the full eligibility criteria
- for long-term follow-up (LTFU) study participants only
- Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 [NCT01364597] and/or N01349 [NCT03325439] for directly enrolled (DE) study participants in Japan only
- Study participant is ≥ 4 years to \< 16 years of age
- Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years
- Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment with at least 1 antiepileptic drug (AED)
- Study participant had at least 1 POS during the 4-week Screening Period
- Exclusion criteria for all study participants
- Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant
- Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV). Exclusion criteria for long-term follow-up (LTFU) study participants...
- Study participant has a history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures
- Study participant has a history of status epilepticus in the 30 days prior to the Screening Visit (ScrV) or during the Screening Period
- Study participant has any clinically significant illness
- Study participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
- Study participant has a clinically significant ECG abnormality
- Study participant had major surgery within 6 months prior to the ScrV
The study team makes the final eligibility decision.
Where it's taking place
- Hawthorne, New York, United States
- Durham, North Carolina, United States
- Leuven, Belgium
- Prague, Czechia
- Loos, France
- Freiburg im Breisgau, Germany
- Budapest, Hungary
- Miskolc, Hungary
- Roma, Italy
- Bunkyō City, Japan
- Chūō, Japan
- Gifu, Japan
- Hiroshima, Japan
- Kodaira-shi, Japan
- Kōshi, Japan
- Kyoto, Japan
- Nagoya, Japan
- Niigata, Japan
- Osaka, Japan
- Ōbu, Japan
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hawthorne, New York, United States; Durham, North Carolina, United States; Leuven, Belgium; Prague, Czechia; Loos, France; Freiburg im Breisgau, Germany and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.