Safety Study of Rufinamide Given as an add-on Therapy to Treat Patients With Seizures
- Registration Number
- NCT04558580
- Lead Sponsor
- University of South Alabama
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rufinamide Rufinamide -
- Primary Outcome Measures
Name Time Method Percentage change in total partial seizure frequency from baseline. 22 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of South Alabama
🇺🇸Mobile, Alabama, United States