Open-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures

NCT02192814 | Completed Phase 3 Results

• 1 other identifier: EP0024
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 5

Brief Summary

EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day) will be administered for 5 days as replacement for oral LCM tablets in Japanese adults with partial-onset seizures.

Conditions

Epilepsy; Partial-onset Seizures

Keywords

Lacosamide; LCM; Epilepsy; Partial-onset seizures; iv

Outcome Measures

Primary Outcomes (2)

• The Total Number of Subjects Experiencing at Least One Adverse Event During the Study

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

  During the study (Screening through End of Study (Day -1 through Day 6))

• The Total Number of Subject Withdrawal Due to Adverse Events During the Study

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

  During the study (Screening through End of Study (Day -1 through Day 6))

Secondary Outcomes (6)

• Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1

  20 minutes prior infusion at Day 1

• Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2

  20 minutes prior infusion at Day 2

• Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5

  20 minutes prior infusion at Day 5

• Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1

  20 minutes prior infusion at Day 1

• Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2

  20 minutes prior infusion at Day 2

Other Outcomes (1)

• The Cumulative Partial-onset Seizure Frequency From Day -1 to Day 5

  From Day -1 to Day 5

Study Arms (1)

Lacosamide (LCM)

EXPERIMENTAL

On Day - 1, LCM oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply. During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days. The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day).

Drug: Lacosamide (200 mg/20 mL)

Interventions

Lacosamide (200 mg/20 mL) DRUG

Active Substance: Lacosamide Pharmaceutical form: Solution for intravenous (iv) infusion Concentration: adapted on concentration of oral dose in EP0009 Route of Administration: Drip infusion

Also known as: Vimpat

Lacosamide (LCM)

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 Japanese and enrolled in EP0009 (NCT01832038) receiving oral Lacosamide (LCM) for the treatment of partial-onset seizures and has been enrolled for at least 8 weeks
• Subject has been on a stable twice daily (bid) dosage regimen of LCM 200 mg/ day to 400 mg/ day, for the 2 weeks prior to entry into EP0024
• Subject has been receiving no more than 3 concomitant Antiepileptic Drugs (AEDs) at doses that have remained stable for the 2 weeks prior to entry into EP0024

You may not qualify if:

• Subject has a history of any kind of status epilepticus within 12-month period prior to study entry
• Subject has actual suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia-Suicide Severity Rating Scale (C-SSRS)

Sponsors & Collaborators

• UCB Japan Co. Ltd.: lead
• Parexel: collaborator

Study Sites (5)

81027

Hamamatsu, Japan

Location

81024

Kodaira, Japan

Location

81025

Sapporo, Japan

Location

81003

Shizuoka, Japan

Location

81023

Suita, Japan

Location

Related Links

• FDA Safety Alerts and Recalls

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 Clinical Trial Call Center
• Organization: UCB Pharma

+1877 822

Study Officials

• UCB Clinical Trial Call Center

  1-877-822-9493

  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: July 11, 2014
• First Posted: July 17, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 25, 2017
• Results First Posted: December 4, 2015

Record last verified: 2017-07

Locations

JP (5)