Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures (a type of epilepsy of fits).

Phase 3

Completed

• Conditions: Refractory Partial-Onset Seizures

• Registration Number: CTRI/2012/01/002344
• Lead Sponsor: UpsherSmith Laboratories Inc

Brief Summary

This is a Phase 3, randomized, multi-national, multicenter, double-blind, placebo–controlled, parallel group study designed to evaluate the efficacy and safety of USL255 as adjunctive therapy in subjects with refractory partial-onset seizures with or without secondary generalization.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-15
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 270

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent reduction from baseline in weekly (7 day) partial-onset seizure frequency during the titration plus maintenance phase.	Weekly (7 day)

Secondary Outcome Measures

Name	Time	Method
Percent reduction from baseline in weekly (7 day) all seizure frequency during the titration plus maintenance phase.	Weekly
Proportions of subjects with greater than or equal 25 percent, greater than or equal 75 percent, and 100 percent reduction in weekly (7 day) partial-onset seizure frequency during the titration, maintenance and titration plus maintenance phases, separately.	Weekly
Proportion of subjects with greater than or equal 50 percent reduction (responder rate) in weekly (7 day) partial-onset seizure frequency during the titration plus maintenance phase compared to baseline.	Weekly
Proportions of subjects with greater than or equal 50 percent reduction (responder rate) in weekly (7 day) partial-onset seizure frequency during the titration and maintenance phases, separately.	Weekly
Percent reductions from baseline in weekly (7 day) partial-onset seizure frequency during the titration and maintenance phases, separately.	Weekly

Trial Locations

Locations (7)

Care Hospital,; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Himalayan Institute of Medical Sciences,; 🇮🇳 Dehradun, UTTARANCHAL, India

Jaslok Hospital And Research Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Krishna Institute of Medical Sciences; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

M. S. Ramaiah Medical College and Hospitals; 🇮🇳 Bangalore, KARNATAKA, India

Mallikatta Neuro Research Centre,; 🇮🇳 Udupi, KARNATAKA, India

Sir Ganga Ram Hospital,; 🇮🇳 Delhi, DELHI, India

Care Hospital,

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr Jagaralpudi Murali Krishna Murthy

Principal investigator

919848012983

jmkmurthy@satyam.net.in