Status:
COMPLETED
Open-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures
Lead Sponsor:
UCB Japan Co. Ltd.
Collaborating Sponsors:
Parexel
Conditions:
Epilepsy
Partial-onset Seizures
Eligibility:
All Genders
16+ years
Phase:
PHASE3
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 administer...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02192814
Start Date
June 1 2014
End Date
December 1 2014
Last Update
August 25 2017
Active Locations (5)
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1
81027
Hamamatsu, Japan
2
81024
Kodaira, Japan
3
81025
Sapporo, Japan
4
81003
Shizuoka, Japan