NCT02192814

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

Completed Phase 3 Results posted Last updated 28 July 2017

What this trial tests

Phase 3 trial testing Lacosamide (200 mg/20 mL) in Epilepsy in 9 participants. Completed in 1 December 2014.

Timeline

1 June 2014

Primary endpoint
1 October 2014

1 December 2014

Quick facts

Lead sponsor	UCB Japan Co. Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	1 June 2014
Primary completion	1 October 2014
Estimated completion	1 December 2014
Sites	5 locations across Japan

Drugs / interventions tested

• Lacosamide (200 mg/20 mL) — full drug profile →

Conditions studied

• Epilepsy — all drugs for Epilepsy →
• Partial-onset Seizures — all drugs for Partial-onset Seizures →

Sponsor

UCB Japan Co. Ltd. — full company profile →

Who can join

16 and older, any sex, with Epilepsy or Partial-onset Seizures. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The Total Number of Subjects Experiencing at Least One Adverse Event During the Study
  Time frame: During the study (Screening through End of Study (Day -1 through Day 6))
  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 (investigat
• The Total Number of Subject Withdrawal Due to Adverse Events During the Study
  Time frame: During the study (Screening through End of Study (Day -1 through Day 6))
  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 (investigat

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.