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

Epilepsy Clinical Trial

Official title:

A Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Intravenous Lacosamide as Replacement for Oral Lacosamide in Japanese Adults With Partial-onset Seizures With or Without Secondary Generalization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192814
• Other study ID #: EP0024
• Secondary ID: EP0024
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2014
• Last updated: January 12, 2016
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Partial-onset Seizures
• Seizures

Intervention

Drug:
• Lacosamide (200 mg/20 mL)
Active Substance: Lacosamide Pharmaceutical form: Solution for intravenous (iv) infusion Concentration: adapted on concentration of oral dose in EP0009 Route of Administration: Drip infusion

Locations

Country	Name	City	State
Japan	81027	Hamamatsu
Japan	81024	Kodaira
Japan	81025	Sapporo
Japan	81003	Shizuoka
Japan	81023	Suita

Sponsors (2)

Lead Sponsor	Collaborator
UCB Japan Co. Ltd.	Parexel

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Cumulative Partial-onset Seizure Frequency From Day -1 to Day 5	No descriptive statistics have been calculated for this exploratory Outcome Measure.	From Day -1 to Day 5	No
Primary	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))	No
Primary	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))	No
Secondary	Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1		20 minutes prior infusion at Day 1	No
Secondary	Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2		20 minutes prior infusion at Day 2	No
Secondary	Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5		20 minutes prior infusion at Day 5	No
Secondary	Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1		20 minutes prior infusion at Day 1	No
Secondary	Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2		20 minutes prior infusion at Day 2	No
Secondary	Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5		20 minutes prior infusion at Day 5	No