CompletedPhase 3

Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures

China, Japan473 participantsStarted 2013-03-26

Plain-language summary

The purpose of this trial is to evaluate the safety and tolerability of long-term administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with Epilepsy who have completed the Treatment and Transition Period of EP0008 \[NCT01710657\]

Who can participate

Age range

16 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject has completed the Treatment and Transition Period of EP0008 \[NCT01710657\] Exclusion Criteria: * Subjects who withdrew from EP0008 \[NCT01710657\]

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With at Least One Adverse Event Reported Spontaneously by the Subject or Observed by the Investigator From Baseline Until the End of Study Visit

Timeframe: From Visit 1 (Week 0) up to approximately Week 323

Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit

Timeframe: From Visit 1 (Week 0) up to approximately Week 323

Trial details

NCT IDNCT01832038

SponsorUCB Pharma SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-07-31

Results submitted2020-07-28

View on ClinicalTrials.gov More Epilepsy trials

Who can participate

Age range

16 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject has completed the Treatment and Transition Period of EP0008 \[NCT01710657\] Exclusion Criteria: * Subjects who withdrew from EP0008 \[NCT01710657\]

What they're measuring

Number of Participants With at Least One Adverse Event Reported Spontaneously by the Subject or Observed by the Investigator From Baseline Until the End of Study Visit

Timeframe: From Visit 1 (Week 0) up to approximately Week 323

Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit

Timeframe: From Visit 1 (Week 0) up to approximately Week 323