Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures

Epilepsy Clinical Trial

Official title:

A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of USL255 as Adjunctive Therapy in Patients With Refractory Partial-Onset Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01142193
• Other study ID #: P09-004
• Secondary ID: 2009-016996-31
• Status: Completed
• Phase: Phase 3
• First received: June 9, 2010
• Last updated: May 19, 2014
• Start date: May 2010
• Est. completion date: January 2013

Study information

• Verified date: May 2014
• Source: Upsher-Smith Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subject has a confirmed diagnosis of partial-onset seizures with or without secondary generalization for at least 12 months prior to Visit 1.

• Currently on a stable dosing regimen of 1 to 3 AEDs for at least 4-weeks prior to Visit 1 (12 weeks for phenobarbital and primidone).

• Have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days, during the 8-week baseline.

Exclusion Criteria:

• Have a history of seizure episodes lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished, within 3 months prior to Visit 1.

• Have a history of pseudoseizures, or status epilepticus, within 3 months prior to Visit 1.

• Have a history of metabolic acidosis, nephrolithiasis, ureterolithiasis, or narrow angle glaucoma.

• Have a history of suicidal attempts, suicidal ideation, or uncontrolled psychiatric illness within 2 years of Visit 1.

• Currently taking, or have taken felbamate within the past 18 months, or have taken vigabatrin in the past.

• Have taken topiramate within the past 6 months.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• USL255

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Upsher-Smith Laboratories

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Canada,  Chile,  Germany,  Greece,  Hungary,  India,  Israel,  New Zealand,  Poland,  Russian Federation,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.		11 weeks	No
Secondary	Proportion of Subjects With =50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.		11 weeks	No
Secondary	Proportion of Subjects With =50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.		3 weeks (weeks 1-3)	No
Secondary	Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.		3 weeks (weeks 1-3)	No
Secondary	Percent Reduction From Baseline in Weekly (7 Day) All Seizure Frequency During the Titration Plus Maintenance Phase.		11 weeks	No
Secondary	Proportion of Subjects With =25%, =75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phases Compared to Baseline.		3 weeks (weeks 1-3)	No
Secondary	Proportion of Subjects With =25%, =75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.		11 weeks	No
Secondary	Proportion of Subjects With =25%, =75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.		8 weeks (weeks 4-11)	No
Secondary	Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.		8 weeks (weeks 4-11)	No
Secondary	Proportion of Subjects =50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.		8 weeks (weeks 4-11)	No