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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508095-11-00 | Registry Identifier | EU Trial Number | |
| U1111-1303-1174 | Other Identifier | Universal Trial Number |
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The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brivaracetam arm | Experimental | Subjects in this arm will receive various brivaracetam doses as oral solution or film-coated tablet twice per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brivaracetam Film-coated tablet | Drug | Drug: Brivaracetam Film-coated tablet Pharmaceutical form: Film-coated tablet Route of administration: Oral use Brivaracetam film-coated tablet [10, 25 or 50 mg] will be administered twice per day in equal doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) during the study | An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP). | From Entry Visit up to the Safety Visit (up to 3 years) |
| Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of investigational medicinal product (IMP) during the study | An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP). | From Entry Visit up to the Safety Visit (up to 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse events (SAEs) during the study | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
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Inclusion Criteria:
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
◦ Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the final dose of IMP.
- Capable of and provides informed consent/assent, and the participant's parent/legal representative/caregiver provides signed informed consent for minor participants, which includes compliance with the requirements and restrictions listed in the Informed Consent form (ICF)/Assent form and in this protocol
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ep0224 50140 | Birmingham | Alabama | 35233-2110 | United States | ||
| Ep0224 50639 |
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
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| Brivaracetam oral solution | Drug | Pharmaceutical form: Oral solution Route of administration: Oral use Brivaracetam oral solution [10 mg/mL]) will be administered twice per day in equal doses. |
|
| From Entry Visit up to the Safety Visit (up to 3 years) |
| Incidence of IMP related TEAEs during the study | An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP). | From Entry Visit up to the Safety Visit (up to 3 years) |
| Orange |
| California |
| 92868 |
| United States |
| Ep0224 50268 | Miami | Florida | 33155 | United States |
| Ep0224 50638 | New Brunswick | New Jersey | 08901 | United States |
| Ep0224 50640 | Winston-Salem | North Carolina | 27157 | United States |
| Ep0224 20321 | Tbilisi | Georgia |
| Ep0224 20322 | Tbilisi | Georgia |
| Ep0224 20323 | Tbilisi | Georgia |
| Ep0224 20324 | Tbilisi | Georgia |
| Ep0224 40144 | Abbiategrasso | Italy |
| Ep0224 40765 | Messina | Italy |
| Ep0224 40764 | Pavia | Italy |
| Ep0224 40629 | Roma | Italy |
| Ep0224 40766 | Roma | Italy |
| Ep0224 40763 | Verona | Italy |
| Ep0224 40767 | Bucharest | Romania |
| Ep0224 40769 | Bucharest | Romania |
| Ep0224 40768 | Iași | Romania |
| Ep0224 40770 | Timișoara | Romania |
| Ep0224 40771 | Bardejov | Slovakia |
| Ep0224 40772 | Dubnica nad Váhom | Slovakia |
| Ep0224 20328 | Uzhhorod | Ukraine |
| ID | Term |
|---|---|
| D004832 | Epilepsy, Absence |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000073376 | Epileptic Syndromes |
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| ID | Term |
|---|---|
| C482793 | brivaracetam |
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