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To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

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ClinicalTrials.gov Identifier: NCT00552305
Recruitment Status : Completed
First Posted : November 1, 2007
Results First Posted : September 2, 2011
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Brief Summary:
The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy.

Condition or disease Intervention/treatment Phase
Partial Epilepsies Drug: lacosamide Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 370 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Extension Trial to Determine Tolerability and Efficacy of Long-term Oral SPM 927 as Adjunctive Therapy in Patients With Partial Seizures
Study Start Date : August 2001
Primary Completion Date : February 2010
Study Completion Date : February 2010


Arm Intervention/treatment
Experimental: Lacosamide
50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing
Drug: lacosamide
50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing throughout the trial
Other Name: Vimpat



Primary Outcome Measures :
  1. Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years) [ Time Frame: During the Treatment Period (up to 8 years) ]
    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

  2. Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years) [ Time Frame: During the Treatment Period (up to 8 years) ]
    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

  3. Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years) [ Time Frame: During the Treatment Period (up to 8 years) ]
    A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.


Secondary Outcome Measures :
  1. Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years) [ Time Frame: Baseline, End of Treatment Period (up to 8 years) ]

    Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.

    Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.


  2. Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years) [ Time Frame: Treatment Period (up to 8 years) ]
    At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completion of parent clinical trial for treatment of partial seizures.

Exclusion Criteria:

  • Receiving any study drug or experimental device other than lacosamide.
  • Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event.

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): NCT00552305


  Show 59 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00552305     History of Changes
Other Study ID Numbers: SP0615
First Posted: November 1, 2007    Key Record Dates
Results First Posted: September 2, 2011
Last Update Posted: August 25, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Seizures
Epilepsies, Partial
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lacosamide
Anticonvulsants