Clinical trial NCT02124564: A Trial to Evaluate the Long Term Safety and Tolerability of Lacosamide Taken as Monotherapy in Adults With Partial-onset Seizures
Official title: Multicenter, Open-Label, Long-Term Study to Investigate the Safety of Conversion to Lacosamide at Doses up to 600 mg/Day as Monotherapy in Japanese Adults With Partial-Onset Seizures With or Without Secondary Generalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Partial-onset Seizures
Keywords: Lacosamide
Epilepsy
Focal, Partial-Onset Seizures with or without secondary generalization
Monotherapy
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2014-04-28
Enrollment: 19
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 the duration of the study
* Female subject of childbearing potential taking enzyme-inducing antiepileptic drugs (EI-AEDs: CBZ, phenytoin, barbiturates, primidone, topiramate) who is not surgically sterile, 2 years postmenopausal or does not practice 1 highly effective method of contraception according to the World Health Organization (WHO) recommendation (ie, depot medroxyprogesterone acetate, norethisterone enantate, intrauterine devices, combined injectables, and progestogen implants) with administration of EI-AEDs or does not practice 2 combined methods of contraception (ie, combined hormonal contraception plus barrier method with spermicidal agent), unless sexually abstinent, for the duration of the study
* Subject has sick sinus syndrome without a pacemaker, or a second or third degree atrioventricular (AV) block, or subject has any other clinically relevant electrocardiogram (ECG) abnormalities
* Subject has a history of convulsive status epilepticus within the last 12 months prior to Visit 1

Primary outcomes:
measure: 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)
measure: 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)
measure: 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)
Secondary outcomes:
measure: Number of Subjects Remaining Seizure Free for 6 Consecutive Months During the Monotherapy Period
timeFrame: From the beginning of the Monotherapy Period to the end of the Follow-Up Period (up to 3.1 years until the time of approval granted)
measure: Number of Subjects Remaining Seizure Free for 12 Consecutive Months During the Monotherapy Period
timeFrame: From the beginning of the Monotherapy Period to the end of the Follow-Up Period (up to 3.1 years until the time of approval granted)
measure: Percentage of Participants in the Monotherapy Period Without Discontinuation Due to Adverse Events (AE) or Lack of Efficacy (LOE)
timeFrame: From the beginning of the Monotherapy Period to the end of the Follow-Up Period (up to 3.1 years until the time of approval granted)
measure: Plasma Concentrations of Lacosamide Versus Time Postdose
timeFrame: From Titration Period up to Week 94
Other outcomes:
Locations:
city: Asaka
country: Japan
facility: 5
city: Hamamatsu
country: Japan
facility: 1
city: Itami
country: Japan
facility: 11
city: Kagoshima
country: Japan
facility: 6
city: Kamakura
country: Japan
facility: 7
city: Nagoya
country: Japan
facility: 10
city: Saitama
country: Japan
facility: 12
city: Sapporo
country: Japan
facility: 8
city: Shinagawa
country: Japan
facility: 13
city: Shizuoka
country: Japan
facility: 4
city: Toyonaka
country: Japan
facility: 9
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: