Phase 3 Epilepsy Trial, Recruiting NCT04715646 Sponsor: UCB Biopharma SRL Condition: Epilepsy
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Phase 3 Epilepsy Trial, Recruiting

NCT04715646
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For people joining from a previous related study (long-term follow-up participants):

  • You are at least 1 month old and have a confirmed diagnosis of epilepsy, and previously took part in one of two specific earlier studies (NCT01364597 or NCT03325439)

For people in Japan joining the study directly (not from a previous study):

  • You are between 4 and 15 years old
  • You have had a brain wave test (EEG) in the last 10 years that is consistent with a type of epilepsy that starts in one part of the brain (focal epilepsy)
  • Your seizures have not been fully controlled even after trying at least one epilepsy medication properly
  • You had at least one seizure during the 4-week check-in period before the study begins

Who may not be able to join:

For all participants:

  • You have a serious medical, neurological, or psychiatric condition, or abnormal test results, that could affect your safety in the study
  • You are currently taking part in another study involving an experimental medication or medical device (other than the drug brivaracetam, which this study uses)

For people joining from a previous related study only:

  • If you are 6 years old or older, you have ever attempted suicide in your lifetime, or have had thoughts of suicide in the past 6 months (as measured by a specific rating scale)

For people in Japan joining the study directly only:

  • You have a history of a type of epilepsy that affects the whole brain at once, seizures caused by psychological factors, or seizures caused by fever
  • You had a prolonged or severe seizure episode in the 30 days before your screening visit or during the screening period
  • You have any significant illness that could affect the study (confirm with trial site)
  • You have abnormal blood or lab test results that could increase risks or affect the study results
  • You have a significant abnormality on a heart electrical test (ECG)
  • You had major surgery within 6 months before the start of the screening visit

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: UCB Cares, 001 844 599 2273 (UCB)

Phone: 0018445992273

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
UCB Biopharma SRL
Registry
ClinicalTrials.gov
Start date
11 March 2021
Est. completion
8 July 2030

Where this trial is recruiting

🇧🇪 Belgium 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇵🇱 Poland 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Incidence of treatment-emergent adverse events (TEAEs) during the study; Incidence of treatment-emergent serious adverse events (SAEs) during the study; Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the study

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov