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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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier:
NCT01832038
First received: March 28, 2013
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Epilepsy
Partial-onset Seizures
Drug: Lacosamide
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Baseline is defined as the Baseline Period of study EP0008 [NCT01710657].

  • 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 ] [ Designated as safety issue: No ]
    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].


Estimated Enrollment: 378
Study Start Date: March 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01832038

  Show 72 Study Locations
Sponsors and Collaborators
UCB Pharma SA
UCB Japan Co. Ltd.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT01832038     History of Changes
Other Study ID Numbers: EP0009
Study First Received: March 28, 2013
Last Updated: October 16, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
China: Food and Drug Administration

Keywords provided by UCB Pharma:
Lacosamide
Epilepsy
Partial-onset Seizures

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lacosamide
Anticonvulsants
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014