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

NCT02124564 | Completed Phase 3 Results

• 1 other identifier: EP0057
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 11

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.

Conditions

Epilepsy; Partial-onset Seizures

Keywords

Lacosamide; Epilepsy; Focal, Partial-Onset Seizures with or without secondary generalization; Monotherapy

Outcome Measures

Primary Outcomes (3)

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

  An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  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

  An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  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

  A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is as infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above

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

Secondary Outcomes (4)

• Number of Subjects Remaining Seizure Free for 6 Consecutive Months During the Monotherapy Period

  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)

• Number of Subjects Remaining Seizure Free for 12 Consecutive Months During the Monotherapy Period

  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)

• Percentage of Participants in the Monotherapy Period Without Discontinuation Due to Adverse Events (AE) or Lack of Efficacy (LOE)

  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)

• Plasma Concentrations of Lacosamide Versus Time Postdose

  From Titration Period up to Week 94

Study Arms (1)

Lacosamide

EXPERIMENTAL

Open-label, single-arm

Drug: Lacosamide

Interventions

Lacosamide DRUG

Lacosamide (LCM) immediate-release, film-coated tablets at a strength of 50 mg orally administered twice daily in two equally divided doses. * 4-week Titration Period: Starting on LCM 100 mg/day increased by 100 mg/day each week until 400 mg/day dose reached at the beginning of Week 4 . * The AED Withdrawal Period and Monotherapy Period (52- week Evaluation Period plus a Follow Up Period): During the AED Withdrawal and Monotherapy Period, the investigator may increase or decrease the dose of LCM to optimize tolerability and seizure control. The LCM dose may be decreased no lower than 200 mg/day or increased, no faster than 100 mg/day per week, up to 600 mg/day.

Also known as: Vimpat

Lacosamide

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Japan Co. Ltd.: lead

Study Sites (11)

5

Asaka, Japan

Location

1

Hamamatsu, Japan

Location

11

Itami, Japan

Location

6

Kagoshima, Japan

Location

7

Kamakura, Japan

Location

10

Nagoya, Japan

Location

12

Saitama, Japan

Location

8

Sapporo, Japan

Location

13

Shinagawa City, Japan

Location

4

Shizuoka, Japan

Location

9

Toyonaka, Japan

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.comTokyo

+1844599

Study Officials

• UCB Cares

  +1 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: April 1, 2014
• Primary Completion: November 21, 2017
• Study Completion: November 21, 2017
• Last Updated: October 28, 2019
• Results First Posted: June 28, 2019

Record last verified: 2019-10

Locations

JP (11)