Trial · NCT04666610
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
NCT04666610, Phase 3, Completed, UCB Biopharma SRL
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT04666610. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04666610
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT04666610
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 154 participants, actual
- Lead sponsor
- UCB Biopharma SRL
- Conditions
- Childhood Absence Epilepsy, Juvenile Absence Epilepsy
- Interventions
- Brivaracetam, Placebo
- First posted
- 2020-12-14
- Last updated
- 2026-10-30
- Other registries' IDs
- eudract:2020-002750-24
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of participants who met the criteria for absence seizure freedom within 4 days prior to or during the 24-hour ambulatory electroencephalogram (EEG) at Day 14 | Day 14 | 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. |
| Secondary | Percentage of participants who met the criteria for absence seizure freedom during the randomized withdrawal (RDW) period as determined by electroencephalogram (EEG) | From Week 13 to Week 17 | Study participants (or their care givers) who believe they are experiencing a recurrence of absence seizures will contact the clinical site for a 1-hour EEG (with hyperventilation (HV)). If no absence seizure is observed during this 1hr EEG (locally read), the study participant will receive a 24-hour ambulatory EEG. If an absence seizure is observed during either EEG, the study participant will be considered as not Absence seizure free and leave the study. If no absence seizures are determined by 1/24hr ambulatory EEG the participant will conduct a 24-hour EEG at week 17. 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. The awake hours from the EEG will be analyzed for absence seizures. Every 24-hour EEG will include HV as a standard provocation test at the beginning of the EEG. |
| Secondary | Percent change from Baseline to Day 14 in number of absence seizures on 24-hour ambulatory electroencephalogram (EEG) | From Baseline to Day 14 | A 24-hour ambulatory electroencephalogram (EEG) will be performed at baseline and 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. This endpoint is the difference between the number of seizures at baseline and Day 14. |
| Secondary | Percentage of participants who met the criteria for absence seizure freedom based on diary during the 4 days prior to the visit at Day 14 | Day 14 | During the study subjects will keep a diary to record daily seizure activity from Visit 1 until end of the randomized withdrawal (RDW) Period. Each seizure type experienced will be recorded. The last 4 study days prior to Day 14 EEG are used for this endpoint. 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. |
| Secondary | Percentage of participants who met the criteria for absence seizure freedom on 24-hour ambulatory electroencephalogram (EEG) at Week 12 | Week 12 | 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. |
| Secondary | Percentage of participants who met the criteria for absence seizure freedom based on diary during the 4 days prior to the visit at Week 12 | Week 12 | During the study subjects will keep a diary to record daily seizure activity from Visit 1 until end of the randomized withdrawal (RDW) Period. Each seizure type experienced will be recorded. The last 4 study days prior to Week 12 EEG are used for this endpoint. 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. |
| Secondary | Percentage of participants with treatment-emergent adverse events (TEAEs) during the study | From Day 1 until End of Safety Follow-Up (up to Week 23) | 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). |
| Secondary | Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment | From Day 1 until End of Down Titration Period (up to Week 21) | 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). |
| Secondary | Percentage of participants with serious adverse events (SAEs) during the study | From Screening Period (Day -14 to Day -2) until End of Safety Follow-Up (up to Week 23) | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Results in permanent or significant disability/incapacity * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above |
| Secondary | Percentage of participants with drug-related treatment-emergent adverse events (TEAEs) during the study | From Baseline (Day -1) until End of Safety Follow-Up (up to Week 23) | 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). 'Drug related AEs' are the subset of AEs that the investigator considers as related to the study drug. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35844134 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04666610
GET https://conductscience.org/api/trials/v1/NCT04666610/registered