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

Withdrawn before enrolling · Phase 3

Conditions studied: Refractory Partial Seizures

In brief

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.

Key facts

Study ID

NCT04558580

Run by

University of South Alabama

People needed

0

Starts

2006-04-01

Expected to finish

2008-12-01

Last updated by the study team

2020-09-22

Who can join

Age: 12 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of South Alabama — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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