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NCT04666610 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age 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.
- Active
- Registry status
- Phase 3
- Development phase
- 153
- Enrollment target
- 20
- Study locations
NCT04666610: Active Phase 3 study of Childhood Absence Epilepsy and Juvenile Absence Epilepsy, sponsored by UCB Biopharma SRL.
NCT04666610 is a Phase 3 study of Childhood Absence Epilepsy and Juvenile Absence Epilepsy that is active but no longer recruiting, run by UCB Biopharma SRL. The registered enrollment target is 153 participants, below the 253-participant average among 3 other Childhood Absence Epilepsy trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04666610, a Phase 3 study of Childhood Absence Epilepsy and Juvenile Absence Epilepsy, is active but no longer recruiting, sponsored by UCB Biopharma SRL.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 153 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to test the efficacy, safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).
Primary Outcome
A 24-hour ambulatory electroencephalogram (EEG) will be performed at day 14. The awake hours from the EEG will be analyzed for absence seizures. Every 24-hour EEG will include hyperventilation as a standard provocation test at the beginning of the EEG. Patient will be regarded as not meeting the criteria for absence seizure freedom if they received benzodiazepine in the 4 days prior to the EEG or during the EEG.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Brivaracetam
Study Locations (20)
Other
- N01269 400 - Tbilisi
- N01269 401 - Tbilisi
- N01269 402 - Tbilisi
- N01269 403 - Tbilisi
- N01269 405 - Tbilisi
- N01269 323 - Messina
- N01269 321 - Milan
- N01269 324 - Milan
- N01269 320 - Pavia
- N01269 322 - Roma
Florida
- N01269 111 - Miami
- N01269 101 - Tampa
- N01269 104 - Winter Park
Alabama
- N01269 115 - Birmingham
California
- N01269 105 - Orange
Colorado
- N01269 116 - Denver
Georgia
- N01269 110 - Augusta
New Jersey
- N01269 100 - New Brunswick
North Carolina
- N01269 109 - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2021-07-29 |
| Est. Completion | 2026-08-24 |
| Phase | Phase 3 |
What the registry record for NCT04666610 still lists
NCT04666610 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 253-participant average among 3 other Childhood Absence Epilepsy trials with a reported enrollment target (40% lower).
The record links to 2 conditions, with Childhood Absence Epilepsy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04666610 names 20 study sites across 9 states, led by Other, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT04666610 about?
NCT04666610 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy". The purpose of the study is to test the efficacy, safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).
What is the current status of trial NCT04666610?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 153 participants. The study started on 2021-07-29. Estimated completion is 2026-08-24.
What conditions does trial NCT04666610 study?
This clinical trial studies the following conditions: Childhood Absence Epilepsy, Juvenile Absence Epilepsy.
What interventions are being tested in trial NCT04666610?
The interventions under investigation include: Placebo (OTHER), Brivaracetam (DRUG).
Who is sponsoring clinical trial NCT04666610?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04666610 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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