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

Partial Epilepsies Clinical Trial

Official title:

An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 in Patients With Partial Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522275
• Other study ID #: SP0756
• Secondary ID: 2014-004398-18
• Status: Completed
• Phase: Phase 3
• Start date: October 2004
• Est. completion date: October 2009

Study information

• Verified date: July 2017
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Partial Epilepsies
• Seizures

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB BIOSCIENCES, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) 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.	During the Treatment Period (Maximum 6 years)
Primary	Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) 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.	During the Treatment Period (Maximum 6 years)
Primary	Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) 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.	During the Treatment Period (Maximum 6 years)
Secondary	Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)	Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.	Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)
Secondary	Percentage of at Least 50 % Responders During the 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.	Treatment Period (Maximum 6 years)

External Links

•   FDA Safety Alerts and Recalls
•   Product Information