Phase 3 Epilepsy Trial, Completed NCT02408549 Sponsor: UCB BIOSCIENCES, Inc. Condition: Epilepsy
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Trial results

AI generated results 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

According to the results reported on ClinicalTrials.gov, this trial (NCT02408549) enrolled 239 participants, all of whom received the medication lacosamide. Of those, 157 completed the study and 82 did not. The trial was a long-term follow-on study that focused on monitoring unwanted events (called adverse events) that occurred during treatment, as well as tracking whether participants developed any new types of seizures — specifically absence seizures (brief "blank staring" episodes) or myoclonic seizures (sudden brief muscle jerks) — that they had not experienced before starting the medication. The reported data shows that out of 239 participants, 222 experienced at least one treatment-emergent adverse event (meaning an unwanted event that appeared or got worse after starting the medication). Of these, 19 participants withdrew from the study because of such events. Regarding new seizure types, the reported data shows that 3 participants developed new absence seizures and 5 developed new myoclonic seizures during the treatment period who had not had those seizure types before. The data also tracked whether absence seizures became more frequent compared to a pre-treatment baseline period: 5 participants showed an increase of up to 25% in days with absence seizures per 28 days, 1 participant showed an increase of more than 25% up to 50%, and no participants showed an increase of more than 50% up to 75%. Figures beyond that range were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Epilepsy Trial, Completed

NCT02408549
Completed Phase 3 🇦🇺 Australian site

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:

  • You must have either completed the related parent study (NCT02408523) or have been a certain type of participant who did not meet that study's requirements from the start ("Baseline failure").
  • In some cases, people who were screened for the parent study but did not fully participate may also be considered, if the study doctor believes you could benefit from the treatment and gets approval from the UCB study team.

Who may not be able to join:

  • You are currently taking another experimental drug or using an experimental medical device (other than the study drug, lacosamide).
  • You met the reasons for being removed from the parent study, or you are currently experiencing a serious medical side effect that has not resolved.
  • You are currently having active thoughts of suicide, as identified by a specific questionnaire used in the study (confirm with trial site).
  • Your liver blood test results are significantly above the normal range — specifically, certain liver enzymes or bilirubin levels that are too high may disqualify you, though some borderline results may be re-tested once to confirm (confirm with trial site for exact details).

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 2 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.

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Trial details

Status
Completed
Phase
Phase 3
Sponsor
UCB BIOSCIENCES, Inc.
Registry
ClinicalTrials.gov
Start date
3 August 2015
Est. completion
30 March 2023

Where this trial is recruiting

🇦🇺 Australia 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇳 China 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇷🇺 Russia 🇸🇰 Slovakia 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of Study Participants With Treatment-emergent Adverse Events (TEAEs) Over the Duration of the Treatment Period; Number of Study Participants Withdrawn Due to TEAEs; Number of Study Participants With New Appearance of Absence and/or Myoclonic Seizures During the Treatment Period; Number of Study Participants With an Increase of up to 25% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982); Number of Study Participants With an Increase of Greater Than (>)25% to 50% in Days With Absence Seizures Per 28 Days During...

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: 2 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