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Trial record 1 of 2 for:    NCT01832038
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Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures

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ClinicalTrials.gov Identifier: NCT01832038
Recruitment Status : Completed
First Posted : April 15, 2013
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

Study Description
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Brief Summary:
The purpose of this trial is to evaluate the safety and tolerability of long-term administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with Epilepsy who have completed the Treatment and Transition Period of EP0008 [NCT01710657]

Condition or disease Intervention/treatment Phase
Epilepsy Partial-onset Seizures Drug: Lacosamide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 473 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label, Uncontrolled, Long-term, Extension Study to Evaluate the Safety and Efficacy of Lacosamide as Adjunctive Therapy in Japanese and Chinese Adults With Partial-onset Seizures With or Without Secondary Generalization
Actual Study Start Date : March 26, 2013
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Lacosamide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lacosamide
Lacosamide treatment of 100 - 400 mg/day for long-term
 Drug: Lacosamide

Strength: Lacosamide (LCM) 50 mg, LCM 100 mg

Formulation: Tablet

Frequency: twice daily during the study period (until the date of approval)

At the completion of EP0008 [NCT01710657], all subjects who choose to enroll in EP0009 will be taking a dose of Lacosamide 200 mg/day. At the beginning of EP0009, the investigator may maintain the LCM dose or increase or decrease the dose. During the Treatment Period, the investigator will be allowed to increase or decrease the dose of LCM to optimize tolerability and seizure reduction. The LCM dose may be decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day.

Other Name: Vimpat


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events (AEs) reported spontaneously by the subject or observed by the investigator from Baseline until the End of Study Visit [ Time Frame: From Visit 1 (Week 0) up to approximately Week 223 ]
  2. Subject withdrawals due to Adverse Events from Baseline until the End of Study Visit [ Time Frame: From Visit 1 (Week 0) up to approximately Week 223 ]

Secondary Outcome Measures :
  1. Percent change in Partial-onset Seizure frequency per 28 days from Baseline until the End of Study Visit [ Time Frame: From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 223 ]
    Baseline is defined as the Baseline Period of study EP0008 [NCT01710657].

  2. 50 % response rate from Baseline of study EP0008 [NCT01710657] until the End of Study Visit [ Time Frame: From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 223 ]
    A responder is defined as a subject that experiences a ≥ 50 % reduction from Baseline in partial-onset seizure frequency per 28 days. Baseline is defined as the Baseline Period of study EP0008 [NCT01710657].


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has completed the Treatment and Transition Period of EP0008 [NCT01710657]

Exclusion Criteria:

  • Subjects who withdrew from EP0008 [NCT01710657]
Contacts and Locations
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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): NCT01832038


Locations
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Sponsors and Collaborators
UCB Pharma SA
UCB Japan Co. Ltd.
Investigators
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Study Director: UCB Cares +1 844 599 2273 (UCB)
More Information
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Responsible Party: UCB Pharma SA
ClinicalTrials.gov Identifier: NCT01832038    
Other Study ID Numbers: EP0009
First Posted: April 15, 2013    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Keywords provided by UCB Pharma ( UCB Pharma SA ):
Lacosamide
Epilepsy
Partial-onset Seizures
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