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Trial record 1 of 1 for:    NCT02192814
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Open-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02192814
Recruitment Status : Completed
First Posted : July 17, 2014
Results First Posted : December 4, 2015
Last Update Posted : August 25, 2017
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )

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.

Condition or disease Intervention/treatment Phase
Epilepsy Partial-onset Seizures Drug: Lacosamide (200 mg/20 mL) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Lacosamide

Arm Intervention/treatment
Experimental: Lacosamide (LCM)

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)

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 Name: Vimpat




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192814


Locations
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Japan
81027
Hamamatsu, Japan
81024
Kodaira, Japan
81025
Sapporo, Japan
81003
Shizuoka, Japan
81023
Suita, Japan
Sponsors and Collaborators
UCB Japan Co. Ltd.
Parexel
Investigators
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Study Director: UCB Clinical Trial Call Center 1-877-822-9493

Additional Information:
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Responsible Party: UCB Japan Co. Ltd.
ClinicalTrials.gov Identifier: NCT02192814    
Other Study ID Numbers: EP0024
EP0024 ( Other Identifier: JAPIC )
First Posted: July 17, 2014    Key Record Dates
Results First Posted: December 4, 2015
Last Update Posted: August 25, 2017
Last Verified: July 2017
Keywords provided by UCB Pharma ( UCB Japan Co. Ltd. ):
Lacosamide
LCM
Epilepsy
Partial-onset seizures
iv
Additional relevant MeSH terms:
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Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lacosamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action