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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00522275
First Posted: August 29, 2007
Last Update Posted: August 28, 2017
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.
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )
  Purpose
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 Intervention Phase
Partial Epilepsies Drug: lacosamide Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 in Patients With Partial Seizures

Resource links provided by NLM:


Further study details as provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):

Primary Outcome Measures:
  • Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) [ Time Frame: During the Treatment Period (Maximum 6 years) ]
    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

  • Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) [ Time Frame: During the Treatment Period (Maximum 6 years) ]
    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

  • Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years) [ Time Frame: During the Treatment Period (Maximum 6 years) ]
    Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.


Secondary Outcome Measures:
  • Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years) [ Time Frame: Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years) ]
    Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.

  • Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years) [ Time Frame: Treatment Period (Maximum 6 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.


Enrollment: 308
Study Start Date: October 2004
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacosamide
Up to 800 mg/day lacosamide (flexible dosing)
Drug: lacosamide
50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (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
  Contacts and Locations
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): NCT00522275


  Show 60 Study Locations
Sponsors and Collaborators
UCB BIOSCIENCES, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Publications:
Responsible Party: UCB BIOSCIENCES, Inc.
ClinicalTrials.gov Identifier: NCT00522275     History of Changes
Other Study ID Numbers: SP0756
2014-004398-18 ( EudraCT Number )
First Submitted: August 27, 2007
First Posted: August 29, 2007
Results First Submitted: October 28, 2010
Results First Posted: November 22, 2010
Last Update Posted: August 28, 2017
Last Verified: July 2017

Keywords provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):
Adjunctive treatment in epilepsy
add-on treatment for epilepsy
partial seizures
AEDs
antiepileptic drugs
seizures

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