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 involved 425 people with epilepsy who were taking lacosamide (a seizure medication). Participants were split into two groups: 106 people received 300 mg per day and 319 people received 400 mg per day. The trial was measuring whether lacosamide could be used on its own (as a "monotherapy") rather than alongside other epilepsy medicines — specifically, it tracked how many participants hit certain warning signs (called "exit criteria") within 112 days, such as a significant increase in seizure frequency or a new type of seizure occurring. The reported data shows that for the primary outcome — the percentage of people in the 400 mg group who reached at least one of those warning signs by Day 112 — the figure was 30.0%. The result for the 300 mg group was not reported for this measure. For a broader secondary measure that also counted people who stopped due to side effects or lack of benefit, the reported figure for the 400 mg group was 32.3%. When looking at how long it took participants to first hit a warning sign, the reported median time was 39 days in the 300 mg group and 45 days in the 400 mg group. Both groups spent a reported median of 71 days on lacosamide as the only medication during the monotherapy phase of the study. The reported data also shows how doctors and patients rated overall change compared to the start of the trial. In the 400 mg group, doctors rated 56 participants as "very much improved" and 116 as "much improved," while patients in that group rated 81 as "very much improved" and 93 as "much improved." Smaller numbers in both groups were rated as minimally or much worse. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 24915838) ↗
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
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 have been diagnosed with epilepsy involving partial seizures (either simple partial seizures with physical movement, or complex partial seizures, with or without spreading to a full seizure)
- You have between 2 and 40 seizures within any 28-day period
- You are taking a steady, stable dose of 1 or 2 approved anti-seizure medications
- If you are taking a second anti-seizure medication, the dose must be at or below half of the lowest recommended dose listed on the US product label (confirm with trial site)
Who may not be able to join:
- You have a history of primary generalized seizures or seizures that cannot be clearly classified into a specific type
- Your seizures mainly consist of auras only (such as unusual sensations or feelings without a full seizure following)
- You have a history of status epilepticus (a prolonged or repeated seizure emergency)
- Your seizures happen in clusters that make them impossible to count individually
- You have more than 5 seizures in a single day
- You are currently taking Benzodiazepines, Phenobarbital, or Primidone (certain types of anti-seizure or sedative medications)
- You have a Vagus Nerve Stimulator (VNS) device implanted
- You have a serious medical or mental health condition
- You have a history of alcohol or drug abuse
- You have previously used certain specific medications, including Ethosuximide, Felbamate (after 1994), or Vigabatrin (after 1997)
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.
Contact this trial
Principal Investigator: UCB Clinical Trial Call Center, +1 877 822 9493 (UCB)
Australian sites
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
Where this trial is recruiting
7 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.