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

University of South Alabama (USA)

Status and phase

Withdrawn

Phase 3

Conditions

Refractory Partial Seizures

Treatments

Drug: Rufinamide

Study type

Interventional

Funder types

Other

Identifiers

NCT04558580

E2080-A001-301

Details and patient eligibility

About

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.

Sex

All

Ages

12 to 80 years old

Volunteers

No Healthy Volunteers

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