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NCT06315322 · ClinicalTrials.gov registry record · Phase 3
A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
A Phase 3 study of Childhood Absence Epilepsy and Juvenile Absence Epilepsy, sponsored by UCB Biopharma SRL.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT06315322: Recruiting Phase 3 study of Childhood Absence Epilepsy and Juvenile Absence Epilepsy, sponsored by UCB Biopharma SRL.
NCT06315322 is a Phase 3 study of Childhood Absence Epilepsy and Juvenile Absence Epilepsy that is actively recruiting participants, run by UCB Biopharma SRL. The registered enrollment target is 120 participants, below the 264-participant average among 3 other Childhood Absence Epilepsy trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06315322, a Phase 3 study of Childhood Absence Epilepsy and Juvenile Absence Epilepsy, is actively recruiting participants, sponsored by UCB Biopharma SRL.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Brivaracetam Film-coated tablet
- DRUG Brivaracetam oral solution
Study Locations (20)
Other
- Ep0224 20321 - Tbilisi
- Ep0224 20322 - Tbilisi
- Ep0224 20323 - Tbilisi
- Ep0224 20324 - Tbilisi
- Ep0224 40144 - Abbiategrasso
- Ep0224 40765 - Messina
- Ep0224 40764 - Pavia
- Ep0224 40629 - Roma
- Ep0224 40766 - Roma
- Ep0224 40763 - Verona
- Ep0224 40767 - Bucharest
- Ep0224 40769 - Bucharest
- Ep0224 40768 - Iași
- Ep0224 40770 - Timișoara
- Ep0224 40771 - Bardejov
Alabama
- Ep0224 50140 - Birmingham
California
- Ep0224 50639 - Orange
Florida
- Ep0224 50268 - Miami
New Jersey
- Ep0224 50638 - New Brunswick
North Carolina
- Ep0224 50640 - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-07-10 |
| Est. Completion | 2030-03-01 |
| Phase | Phase 3 |
What NCT06315322 shows while recruiting
NCT06315322 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 264-participant average among 3 other Childhood Absence Epilepsy trials with a reported enrollment target (55% lower).
The record links to 2 conditions, with Childhood Absence Epilepsy appearing as the primary indexed condition, and to 2 interventions - of which Brivaracetam Film-coated tablet is the first listed.
NCT06315322 names 20 study sites across 6 states, led by Other, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT06315322 about?
NCT06315322 is a clinical study titled "A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy". 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.
What is the current status of trial NCT06315322?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2024-07-10. Estimated completion is 2030-03-01.
What conditions does trial NCT06315322 study?
This clinical trial studies the following conditions: Childhood Absence Epilepsy, Juvenile Absence Epilepsy.
What interventions are being tested in trial NCT06315322?
The interventions under investigation include: Brivaracetam Film-coated tablet (DRUG), Brivaracetam oral solution (DRUG).
Who is sponsoring clinical trial NCT06315322?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06315322 being conducted?
This trial has 20 study locations across Alabama, California, Florida, New Jersey, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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