CompletedPhase 3

A Trial to Evaluate the Long Term Safety and Tolerability of Lacosamide Taken as Monotherapy in Adults With Partial-onset Seizures

Japan19 participantsStarted 2014-04

Plain-language summary

This study is to evaluate the long-term safety and tolerability of Lacosamide (LCM) 200 mg/day to LCM 600 mg/day taken in monotherapy in Japanese subjects who currently have partial-onset seizures with or without secondary generalization and who are treated with a single Anti-Epileptic Drug (AED) with marketing approval in Japan.

Who can participate

Age range

16 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 is male or female and ≥16 years of age * Subject has a diagnosis of epilepsy, having experienced unprovoked partial-onset seizures (IA, IB, or IC with clear focal origin) that are classifiable according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981 * Subject experiences partial-onset seizures despite appropriately chosen and adequately tried treatment with 1 antiepileptic drug (AED) * Subject has been treated for epilepsy with a stable dose of 1 marketed AED The use of benzodiazepines is permitted as rescue therapy for epilepsy. Benzodiazepines may have been used as needed but not more frequently than once per week. Exclusion Criteria: * Subject has a history or presence of seizures of other types than partial onset (IA, IB, or IC with clear focal origin) * Subject is taking benzodiazepines for a nonepilepsy indication (Exception: Concomitant use of benzodiazepines is allowed if the subject is taking them on a regular basis, has been on a stable dose for at least 1 month prior to Visit 1, and does not require changes in the dosage and administration throughout the study period. However, concomitant use of benzodiazepines on an as needed basis is not permitted.) * Female subject who is pregnant or nursing, and/or a woman of childbearing potential who is not surgically sterile, 2 years postmenopausal or does not practice 1 highly effective method of contraception, unless sexually abstinent, for th…

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 Subjects With at Least One Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Study

Timeframe: From the Titration Period (investigational product is taken) to the End of Study Visit (up to 3.5 years)

Number of Subjects Who Withdraw Due to Adverse Events (AEs) During the Study

Timeframe: From the Titration Period (investigational product is taken) to the End of Study Visit (up to 3.5 years)

Number of Subjects With at Least One Incidence of Serious Adverse Events (SAEs) During the Study

Timeframe: From the Titration Period (investigational product is taken) to the End of Study Visit (up to 3.5 years)

Trial details

NCT IDNCT02124564

SponsorUCB Japan Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-11-21

Results submitted2018-11-21

View on ClinicalTrials.gov More Epilepsy trials

Plain-language summary

Who can participate

Age range

16 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.

What they're measuring

Number of Subjects With at Least One Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Study

Timeframe: From the Titration Period (investigational product is taken) to the End of Study Visit (up to 3.5 years)

Number of Subjects Who Withdraw Due to Adverse Events (AEs) During the Study

Timeframe: From the Titration Period (investigational product is taken) to the End of Study Visit (up to 3.5 years)

Number of Subjects With at Least One Incidence of Serious Adverse Events (SAEs) During the Study

Timeframe: From the Titration Period (investigational product is taken) to the End of Study Visit (up to 3.5 years)