Clinical Trial Results:
A Multicenter, Open-Label, Single-Arm Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
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Summary
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EudraCT number |
2020-002769-33 |
Trial protocol |
HU BE IT PL SK Outside EU/EEA RO ES |
Global end of trial date |
18 Mar 2025
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Results information
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Results version number |
v1(current) |
This version publication date |
23 Oct 2025
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First version publication date |
23 Oct 2025
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
EP0132
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05109234 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
UCB Biopharma SRL
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Sponsor organisation address |
Allée de la Recherche 60, Brussels, Belgium, 1070
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Public contact |
UCB BIOSCIENCES GmbH, Clin Trial Reg & Results Disclosure, clinicaltrials@ucb.com
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Scientific contact |
UCB BIOSCIENCES GmbH, Clin Trial Reg & Results Disclosure, clinicaltrials@ucb.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000332-PIP02-17 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Apr 2025
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
18 Mar 2025
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Mar 2025
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The purpose of the study is to investigate the long-term safety, tolerability and efficacy of brivaracetam (BRV) in pediatric study participants with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).
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Protection of trial subjects |
During the conduct of the study all participants were closely monitored.
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Background therapy |
Background therapy as permitted in the protocol. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Mar 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Georgia: 39
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Country: Number of subjects enrolled |
Italy: 7
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Country: Number of subjects enrolled |
Romania: 17
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Country: Number of subjects enrolled |
Slovakia: 3
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Country: Number of subjects enrolled |
Ukraine: 4
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Country: Number of subjects enrolled |
United States: 14
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Worldwide total number of subjects |
84
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EEA total number of subjects |
27
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
55
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Adolescents (12-17 years) |
29
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The study started to enroll participants in March 2022 and concluded in March 2025. | |||||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
The Participant Flow refers to the Safety Set (SS). Participants who participated in N01269 (NCT04666610) were offered participation in this study. | |||||||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Childhood Absence Epilepsy (CAE): Brivaracetam | |||||||||||||||||||||||||||||||||
Arm description |
Participants with CAE entered Evaluation Period to receive BRV, tablet or oral solution dose of 100 mg/day(or equivalent doses of 2 mg/kg/day for participants weighing <50 kg).Dose could be adjusted after 3 days from 50-200 mg/day(or equivalent dose of 1-4 mg/kg/day for participants <50 kg)based on individual needs.Maximum allowed daily dose =200 mg/day (or equivalent dose of 4 mg/kg/day for participants <50 kg).Duration per participant was 2 years minimum,until approval of BRV for indication of CAE was obtained for pediatric participants in their age range,until MAP was established as allowed per country-specific requirements and legal/regulatory guidelines, or until investigational product development in related indication is stopped by Sponsor, whichever come first. Participants transitioned to another BRV study EP0224(NCT06315322)/MAP/similar program/who convert to commercial BRV, FV instead of EDV needed; down-titration(dose reduction to half during 4 weeks); SV not applicable. | |||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Brivaracetam
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet, Oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
Brivaracetam tablet dose of 100 mg/day (or equivalent doses of 2 mg/kg/day for participants weighing <50 kg). Dose may be adjusted after 3 days from 50-200 mg/day (or equivalent dose of 1-4 mg/kg/day for participants <50 kg) based on individual needs. Maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for participants <50 kg).
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Arm title
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Juvenile Absence Epilepsy (JAE): Brivaracetam | |||||||||||||||||||||||||||||||||
Arm description |
Participants with JAE entered Evaluation Period to receive BRV, tablet or oral solution dose of 100 mg/day(or equivalent doses of 2 mg/kg/day for participants weighing <50 kg).Dose could be adjusted after 3 days from 50-200 mg/day(or equivalent dose of 1-4 mg/kg/day for participants <50 kg)based on individual needs.Maximum allowed daily dose =200 mg/day (or equivalent dose of 4 mg/kg/day for participants <50 kg).Duration per participant was 2 years minimum,until approval of BRV for indication of JAE was obtained for pediatric participants in their age range,until MAP was established as allowed per country-specific requirements and legal/regulatory guidelines, or until investigational product development in related indication is stopped by Sponsor, whichever come first. Participants transitioned to another BRV study EP0224(NCT06315322)/MAP/similar program/who convert to commercial BRV,FV instead of EDV needed; down-titration(dose reduction to half during 4 weeks); SV not applicable. | |||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Brivaracetam
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet, Oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
Brivaracetam tablet dose of 100 mg/day (or equivalent doses of 2 mg/kg/day for participants weighing <50 kg). Dose may be adjusted after 3 days from 50-200 mg/day (or equivalent dose of 1-4 mg/kg/day for participants <50 kg) based on individual needs. Maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for participants <50 kg).
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Baseline characteristics reporting groups
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Reporting group title |
Childhood Absence Epilepsy (CAE): Brivaracetam
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Reporting group description |
Participants with CAE entered Evaluation Period to receive BRV, tablet or oral solution dose of 100 mg/day(or equivalent doses of 2 mg/kg/day for participants weighing <50 kg).Dose could be adjusted after 3 days from 50-200 mg/day(or equivalent dose of 1-4 mg/kg/day for participants <50 kg)based on individual needs.Maximum allowed daily dose =200 mg/day (or equivalent dose of 4 mg/kg/day for participants <50 kg).Duration per participant was 2 years minimum,until approval of BRV for indication of CAE was obtained for pediatric participants in their age range,until MAP was established as allowed per country-specific requirements and legal/regulatory guidelines, or until investigational product development in related indication is stopped by Sponsor, whichever come first. Participants transitioned to another BRV study EP0224(NCT06315322)/MAP/similar program/who convert to commercial BRV, FV instead of EDV needed; down-titration(dose reduction to half during 4 weeks); SV not applicable. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Juvenile Absence Epilepsy (JAE): Brivaracetam
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Reporting group description |
Participants with JAE entered Evaluation Period to receive BRV, tablet or oral solution dose of 100 mg/day(or equivalent doses of 2 mg/kg/day for participants weighing <50 kg).Dose could be adjusted after 3 days from 50-200 mg/day(or equivalent dose of 1-4 mg/kg/day for participants <50 kg)based on individual needs.Maximum allowed daily dose =200 mg/day (or equivalent dose of 4 mg/kg/day for participants <50 kg).Duration per participant was 2 years minimum,until approval of BRV for indication of JAE was obtained for pediatric participants in their age range,until MAP was established as allowed per country-specific requirements and legal/regulatory guidelines, or until investigational product development in related indication is stopped by Sponsor, whichever come first. Participants transitioned to another BRV study EP0224(NCT06315322)/MAP/similar program/who convert to commercial BRV,FV instead of EDV needed; down-titration(dose reduction to half during 4 weeks); SV not applicable. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Childhood Absence Epilepsy (CAE): Brivaracetam
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Reporting group description |
Participants with CAE entered Evaluation Period to receive BRV, tablet or oral solution dose of 100 mg/day(or equivalent doses of 2 mg/kg/day for participants weighing <50 kg).Dose could be adjusted after 3 days from 50-200 mg/day(or equivalent dose of 1-4 mg/kg/day for participants <50 kg)based on individual needs.Maximum allowed daily dose =200 mg/day (or equivalent dose of 4 mg/kg/day for participants <50 kg).Duration per participant was 2 years minimum,until approval of BRV for indication of CAE was obtained for pediatric participants in their age range,until MAP was established as allowed per country-specific requirements and legal/regulatory guidelines, or until investigational product development in related indication is stopped by Sponsor, whichever come first. Participants transitioned to another BRV study EP0224(NCT06315322)/MAP/similar program/who convert to commercial BRV, FV instead of EDV needed; down-titration(dose reduction to half during 4 weeks); SV not applicable. | ||
Reporting group title |
Juvenile Absence Epilepsy (JAE): Brivaracetam
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Reporting group description |
Participants with JAE entered Evaluation Period to receive BRV, tablet or oral solution dose of 100 mg/day(or equivalent doses of 2 mg/kg/day for participants weighing <50 kg).Dose could be adjusted after 3 days from 50-200 mg/day(or equivalent dose of 1-4 mg/kg/day for participants <50 kg)based on individual needs.Maximum allowed daily dose =200 mg/day (or equivalent dose of 4 mg/kg/day for participants <50 kg).Duration per participant was 2 years minimum,until approval of BRV for indication of JAE was obtained for pediatric participants in their age range,until MAP was established as allowed per country-specific requirements and legal/regulatory guidelines, or until investigational product development in related indication is stopped by Sponsor, whichever come first. Participants transitioned to another BRV study EP0224(NCT06315322)/MAP/similar program/who convert to commercial BRV,FV instead of EDV needed; down-titration(dose reduction to half during 4 weeks); SV not applicable. | ||
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End point title |
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) [1] | ||||||||||||
End point description |
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. TEAEs are defined as AEs that had onset on or after the day of first dose of BRV. The SS consisted of all enrolled study participants who took at least 1 dose of study drug in the long-term follow-up (LTFU) study.
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End point type |
Primary
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End point timeframe |
From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Participants with TEAEs Leading to Discontinuation of Study Treatment [2] | ||||||||||||
End point description |
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. TEAEs are defined as AEs that had onset on or after the day of first dose of BRV. Percentage of participants with TEAEs leading to discontinuation were reported. The SS consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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End point type |
Primary
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End point timeframe |
From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Participants with Serious TEAEs | ||||||||||||
End point description |
TEAEs are defined as AEs that had onset on or after the day of first dose of BRV. 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. The SS consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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End point type |
Secondary
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End point timeframe |
From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Participants with Study Drug-related TEAEs | ||||||||||||
End point description |
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. TEAEs are defined as AEs that had onset on or after the day of first dose of BRV. Drug related AEs are the subset of AEs that the investigator considers as related to the study drug. The SS consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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End point type |
Secondary
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End point timeframe |
From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Participants with Absence Seizure Freedom Within 4 Days Prior to or During the 1-hour Electroencephalogram (EEG) | ||||||||||||||||||||||||
End point description |
A 1-hour EEG was performed. The awake hours from the EEG was analyzed for absence seizures. Every 1-hour EEG included hyperventilation as a standard provocation test at the beginning of the EEG. Participant was regarded as not meeting the criteria for absence seizure freedom if they received any permitted antiepileptic drugs including benzodiazepine in the 4 days prior to the EEG or during the EEG. Participants who continue in the study beyond 2 years have their data truncated at Year 2 Month 24 yearly evaluation visit (YEV). The SS consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study. Here, number of participants analyzed 'N' included all participants who were evaluable for this assessment and 'n' signifies participants who were evaluable at each specified timepoints.
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End point type |
Secondary
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End point timeframe |
Full Evaluation Visit (6 months), Yearly Evaluation Visit (12 months), Full Evaluation Visit (18 months), Yearly Evaluation Visit (24 months)
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Percentage of Participants with Absence Seizure Freedom Based on Daily Seizure Diary Over the Entire Evaluation Period and by 3-month Time Intervals | |||||||||||||||||||||||||||||||||||||||
End point description |
During the study, participants kept diary to record daily seizure activity from entry visit (Visit 1) until final visit. Each seizure type experienced were recorded. Participant was considered as not meeting criteria for absence seizure freedom if they use any permitted anti-epileptic drugs at any time during the period, and/or complete less than 80% of diaries during the period. Evaluation Period includes all daily seizure diary data over Evaluation Period up to Month 24 YEV, this includes data from end of Months 22 to 24 up to Month 24 YEV where this data is truncated. If a participant does not attend Month 24 YEV then data was truncated at last day participant is in Evaluation Period in Month 24 YEV window. Participants who continue in study beyond 2 years have their data truncated at Year 2 Month 24 YEV, or last day participant was in Evaluation Period in Month 24 YEV window if this visit is not attended. The SS was used. 'n' =participants evaluable at each specified timepoints.
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End point type |
Secondary
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End point timeframe |
Months 1-3, Months 4-6, Months 7-9, Months 10-12, Months 13-15, Months 16-18, Months 19-21, Months 22-24 and Entire Evaluation Period (Up to 24 months)
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
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Adverse event reporting additional description |
Treatment-emergent adverse events were defined as AEs that had onset on or after the day of first dose of BRV. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
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Reporting groups
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Reporting group title |
Juvenile Absence Epilepsy (JAE): Brivaracetam
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Reporting group description |
Participants with JAE entered Evaluation Period to receive BRV, tablet or oral solution dose of 100 mg/day(or equivalent doses of 2 mg/kg/day for participants weighing <50 kg).Dose could be adjusted after 3 days from 50-200 mg/day(or equivalent dose of 1-4 mg/kg/day for participants <50 kg)based on individual needs.Maximum allowed daily dose =200 mg/day (or equivalent dose of 4 mg/kg/day for participants <50 kg).Duration per participant was 2 years minimum,until approval of BRV for indication of JAE was obtained for pediatric participants in their age range,until MAP was established as allowed per country-specific requirements and legal/regulatory guidelines, or until investigational product development in related indication is stopped by Sponsor, whichever come first. Participants transitioned to another BRV study EP0224(NCT06315322)/MAP/similar program/who convert to commercial BRV, FV instead of EDV needed; down-titration(dose reduction to half during 4 weeks); SV not applicable. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Childhood Absence Epilepsy (CAE): Brivaracetam
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Reporting group description |
Participants with CAE entered Evaluation Period to receive BRV, tablet or oral solution dose of 100 mg/day(or equivalent doses of 2 mg/kg/day for participants weighing <50 kg).Dose could be adjusted after 3 days from 50-200 mg/day(or equivalent dose of 1-4 mg/kg/day for participants <50 kg)based on individual needs.Maximum allowed daily dose =200 mg/day (or equivalent dose of 4 mg/kg/day for participants <50 kg).Duration per participant was 2 years minimum,until approval of BRV for indication of CAE was obtained for pediatric participants in their age range,until MAP was established as allowed per country-specific requirements and legal/regulatory guidelines, or until investigational product development in related indication is stopped by Sponsor, whichever come first. Participants transitioned to another BRV study EP0224(NCT06315322)/MAP/similar program/who convert to commercial BRV, FV instead of EDV needed; down-titration(dose reduction to half during 4 weeks); SV not applicable. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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08 Sep 2020 |
Protocol Amendment 1 was dated 08 Sept 2020. The purpose of this substantial amendment was to remove all decentralized
study components as it was decided that all participant visits will occur on site. Centrally read 24-hour electroencephalogram (EEGs) were removed; locally read 1-hour EEGs that reflect
normal clinical practice will be used in this study. In addition, the Conners Continuous Performance Tests (CPT), Achenbach Childhood Behavior Checklist (CBCL), and EuroQol 5-
Dimension (EQ-5D) Quality of Life Assessments have been removed from the list of participantand caregiver-reported outcomes and the wearable EEG (SeizeIT) substudy has been removed. |
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29 Mar 2021 |
Protocol Amendment 2 was dated 29 Mar 2021. The purpose of this substantial amendment was to address Health Authority feedback, correct minor errors/inconsistencies, provide additional clarifying information. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| EP0132 enrolled fewer participants than expected (approximately 140) so it was closed prematurely, followed by initiation of managed access program EP0225 (NCTID not applicable) and its replacement with the new open-label study EP0224 (NCT06315322). | |||
