To Determine Tolerability 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 Tolerability and Efficacy of Long-term Oral SPM 927 as Adjunctive Therapy in Patients With Partial Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552305
• Other study ID #: SP0615
• Status: Completed
• Phase: Phase 2
• Start date: August 2001
• Est. completion date: February 2010

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: 370
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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
• Partial Epilepsies
• Seizures

Intervention

Drug:
• lacosamide
50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing throughout the trial

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Germany,  Hungary,  Lithuania,  Poland,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) 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.	During the Treatment Period (up to 8 years)
Primary	Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) 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.	During the Treatment Period (up to 8 years)
Primary	Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) 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.	During the Treatment Period (up to 8 years)
Secondary	Median Percentage Change From Baseline in 28-day Seizure Frequency During the 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.	Baseline, End of Treatment Period (up to 8 years)
Secondary	Percentage of at Least 50% Responders During the 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	Treatment Period (up to 8 years)

External Links

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