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Completed

NCT Number: NCT02192814

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Partial-onset Seizures

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

81027, Hamamatsu, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other names: Vimpat

Primary outcomes

  1. 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 (investigational) product, whether or not related to the medicinal (investigational) product.

  2. 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 (investigational) product, whether or not related to the medicinal (investigational) product.

Secondary outcomes

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

    Time frame: 20 minutes prior infusion at Day 1

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

    Time frame: 20 minutes prior infusion at Day 2

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

    Time frame: 20 minutes prior infusion at Day 5

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

    Time frame: 20 minutes prior infusion at Day 1

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

    Time frame: 20 minutes prior infusion at Day 2

  6. Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5

    Time frame: 20 minutes prior infusion at Day 5

Other outcomes

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

    Time frame: From Day -1 to Day 5

    No descriptive statistics have been calculated for this exploratory Outcome Measure.

Sponsors and collaborators

Lead sponsor

UCB Japan Co. Ltd.

Industry

Collaborators

  • Parexel

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 17, 2014
Registry last updated
Aug 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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