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Brivaracetam for Childhood Absence Epilepsy

N01269 Site 103, Loxahatchee Groves, FL
Childhood Absence Epilepsy+1 More ConditionsBrivaracetam - Drug
Eligibility
2 - 25
All Sexes

Study Summary

This trial is testing a new drug for kids with absence seizures.

Eligible Conditions
  • Childhood Absence Epilepsy
  • Juvenile Absence Epilepsy

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
Lacosamide oral
2
DMX-200
1
Ketamine Hydrochloride

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: From Screening Period (Day -14 to Day -2) until End of Safety Follow-Up (up to Week 23)

Day 14
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
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
Week 23
Percentage of participants with drug-related treatment-emergent adverse events (TEAEs) during the study
Day 14
Electroencephalography
Week 21
Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment
Week 23
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
Week 23
Percentage of participants with serious adverse events (SAEs) during the study
Week 17
Percentage of participants who met the criteria for absence seizure freedom during the randomized withdrawal (RDW) period as determined by electroencephalogram (EEG)
Week 12
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
Percentage of participants who met the criteria for absence seizure freedom on 24-hour ambulatory electroencephalogram (EEG) at Week 12

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
Lacosamide oral
3
DMX-200
2
Ketamine Hydrochloride

Side Effects for

Brivaracetam
25%Headache
21%Dizziness
14%Somnolence
14%Nasopharyngitis
13%Influenza
11%Upper respiratory tract infection
10%Diarrhoea
10%Urinary tract infection
10%Depression
10%Back pain
10%Convulsion
10%Pyrexia
10%Nausea
9%Vomiting
8%Arthralgia
8%Fatigue
7%Pain in extremity
7%Cough
7%Insomnia
7%Hypertension
7%Anxiety
6%Abdominal pain
6%Irritability
6%Tremor
6%Fall
6%Constipation
6%Toothache
5%Laceration
5%Contusion
5%Decreased appetite
5%Rash
1%Pneumonia
1%Pregnancy
1%Toxicity to various agents
1%Suicide attempt
1%Transient ischaemic attack
1%Status epilepticus
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT00150800) in the Brivaracetam ARM group. Side effects include: Headache with 25%, Dizziness with 21%, Somnolence with 14%, Nasopharyngitis with 14%, Influenza with 13%.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

8 Treatment Groups

Optimal dose of BRV (defined following Stage 1)
1 of 8
Placebo to BRV optimal dose (defined following Stage 1)
1 of 8
Brivaracetam 200 mg
1 of 8
Placebo to 200 mg brivaracetam
1 of 8
Brivaracetam 100 mg
1 of 8
Placebo to 100 mg brivaracetam
1 of 8
Brivaracetam received during RDW
1 of 8
Placebo received during RDW
1 of 8

Experimental Treatment

160 Total Participants · 8 Treatment Groups

Primary Treatment: Brivaracetam · Has Placebo Group · Phase 3

Optimal dose of BRV (defined following Stage 1)
Drug
Experimental Group · 1 Intervention: Brivaracetam · Intervention Types: Drug
Placebo to BRV optimal dose (defined following Stage 1)Experimental Group · 2 Interventions: Brivaracetam, Placebo · Intervention Types: Drug, Other
Brivaracetam 200 mg
Drug
Experimental Group · 1 Intervention: Brivaracetam · Intervention Types: Drug
Placebo to 200 mg brivaracetamExperimental Group · 2 Interventions: Brivaracetam, Placebo · Intervention Types: Drug, Other
Brivaracetam 100 mg
Drug
Experimental Group · 1 Intervention: Brivaracetam · Intervention Types: Drug
Placebo to 100 mg brivaracetamExperimental Group · 2 Interventions: Brivaracetam, Placebo · Intervention Types: Drug, Other
Brivaracetam received during RDW
Drug
Experimental Group · 1 Intervention: Brivaracetam · Intervention Types: Drug
Placebo received during RDWExperimental Group · 2 Interventions: Brivaracetam, Placebo · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brivaracetam
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from screening period (day -14 to day -2) until end of safety follow-up (up to week 23)

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
87 Previous Clinical Trials
20,342 Total Patients Enrolled
1 Trials studying Childhood Absence Epilepsy
140 Patients Enrolled for Childhood Absence Epilepsy
UCB CaresStudy Director001 844 599 2273 (UCB)
190 Previous Clinical Trials
43,028 Total Patients Enrolled
1 Trials studying Childhood Absence Epilepsy
140 Patients Enrolled for Childhood Absence Epilepsy

Eligibility Criteria

Age 2 - 25 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Both males and females are eligible.
References

Frequently Asked Questions

Could you please summarize the risks associated with Brivaracetam?

"Brivaracetam has received a safety score of 3. This is based on the fact that it is a Phase 3 trial, meaning there is some data supporting efficacy and multiple rounds of data supporting safety." - Anonymous Online Contributor

Unverified Answer

Will this clinical trial provide new information not yet gathered?

"Brivaracetam was first studied in 2017 by UCB Biopharma S.P.R.L.. The company's initial study involved 227 people and, after Phase 3 approval, 6 more live studies were launched in 16 different countries." - Anonymous Online Contributor

Unverified Answer

For which patients is this research project meant?

"This medical trial is looking for 160 participants that suffer from childhood absence epilepsy, are aged 2-25, and meet the following additional requirements: They must be untreated with antiepileptic drugs (AEDs) or pretreated for absence seizures with a maximum of 2 historical AEDs, but without AED treatment for a period of at least 5 half-lives of the AED before randomization into this study. The UCB study physician should be consulted if in doubt, Study participant is without treatment with psychoactive drugs or on a stable dose for at least 2 weeks prior to randomization, Body weight is" - Anonymous Online Contributor

Unverified Answer

What do we know about Brivaracetam from other research?

"Brivaracetam is being studied in six clinical trials, four of which are Phase 3. Although the majority of research for Brivaracetam takes place in Poznan and New York, there are a total of 197 locations conducting these medical studies." - Anonymous Online Contributor

Unverified Answer

Are there many places in the state where this clinical trial is taking place?

"Right now, there are 17 clinical trial sites looking for patients to enroll. If you choose to participate in this study, it is important to try and pick a location near you so that travelling isn't too much of an inconvenience. The locations recruiting patients right now are Orlando, Wellington, Denver and 14 other places." - Anonymous Online Contributor

Unverified Answer

If a patient is under 40, do they still qualify for the research program?

"This trial is only for children aged 2 to 25. Out of the other 270 trials, 111 are for patients under 18 and 159 are for senior citizens over 65 years old." - Anonymous Online Contributor

Unverified Answer

How many people are taking part in this research project?

"One hundred and sixty patients who meet the specific inclusion criteria are needed for this clinical trial. The locations of these medical centres include Orlando, Colorado and Wellington, California." - Anonymous Online Contributor

Unverified Answer

Are people still being accepted into this trial program?

"That is correct, the clinical trial mentioned is still recruiting patients. Based on the information found on clinicaltrials.gov, the trial was posted on 7/29/2021 and last edited on 11/10/2022. A total of 160 patients are being enrolled at 17 different locations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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