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

• ClinicalTrials.gov Identifier: NCT00522275
• Recruitment Status: Completed
• First Posted: August 29, 2007
• Results First Posted: November 22, 2010
• Last Update Posted: July 18, 2018
• Sponsor: UCB BIOSCIENCES, Inc.
• Information provided by (Responsible Party): UCB Pharma ( UCB BIOSCIENCES, Inc. )

Tracking Information

• First Submitted Date: August 27, 2007
• First Posted Date: August 29, 2007
• Results First Submitted Date: October 28, 2010
• Results First Posted Date: November 22, 2010
• Last Update Posted Date: July 18, 2018
• Study Start Date: October 2004
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 18, 2015)

• 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.

• Original Primary Outcome Measures (submitted: August 27, 2007): Safety of long-term exposure to lacosamide was evaluated with the monitoring of adverse events (AEs), ECGs, vital signs, and clinical laboratory data. [ Time Frame: At periodic clinic visits throughout the trial ]

Current Secondary Outcome Measures (submitted: April 7, 2015)

• 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.

• Original Secondary Outcome Measures (submitted: August 27, 2007): Efficacy and maintenance of efficacy with long-term exposure to lacosamide is evaluated based on reduction in seizure frequency, 50 percent reduction in seizures, number and percentage of seizure-free days, and achievement of seizure-free status. [ Time Frame: At periodic clinic visits throughout the trial ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
• Official Title: An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 in Patients With Partial Seizures
• 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Partial Epilepsies

Intervention

Drug: lacosamide

50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial

Study Arms

Experimental: Lacosamide

Up to 800 mg/day lacosamide (flexible dosing)

Intervention: Drug: lacosamide

• Publications *: Husain A, Chung S, Faught E, Isojarvi J, McShea C, Doty P. Long-term safety and efficacy in patients with uncontrolled partial-onset seizures treated with adjunctive lacosamide: results from a Phase III open-label extension trial. Epilepsia. 2012 Mar;53(3):521-8. doi: 10.1111/j.1528-1167.2012.03407.x.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 27, 2007): 308
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2009
• Actual Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 70 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00522275
• Other Study ID Numbers: SP0756; 2014-004398-18 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
• Study Sponsor: UCB BIOSCIENCES, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

• PRS Account: UCB Pharma
• Verification Date: July 2017