Safety Study of Rufinamide Given as an add-on Therapy to Treat Patients With Seizures

• Status: Withdrawn
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of Rufinamide in reducing seizure frequency in subjects with partial seizures not fully controlled despite treatment with 1 to 3 concomitant antiepileptic drugs.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Alabama
• Treatments: Rufinamide

Criteria

Inclusion Criteria:

• Male and Female patients between 12 and 80 years of age

• Dx of epilepsy with partial onset seizures woth or woth out secondarily generalized seizures

• Non controlled partial seizures despite treatment with 2 different AEDs for at least 2 years

• must have 6 seizures during baseline

• current treatment with maximum of 3 AEDs

• stable dose of AED(s)for at least 1 month

• if patient has VNS, must have been implanted 6 months prior to randomization

Exclusion Criteria:

• Participation in any investigational product for at least 1 month prior to visit 1

• Presence of non-motor simple partial seizures only

• presence of generalized epilepsies

• Evidence of clinically significant disease

• Clinically significant ECG

• Psychogenic seizure in previous year

• History of drug/alcohol abuse

• History of suicide attempt

• Multiple drug allergies

• Concomitant felbamate use

• Need for frequent rescue benzodiazepines

• Concomitant use of vigabatrin

• All patients diagnosed with congenital short QT syndrome