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

Refractory Partial Seizures Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04558580
• Other study ID #: E2080-A001-301
• Status: Withdrawn
• Phase: Phase 3
• Start date: April 2006
• Est. completion date: December 2008

Study information

• Verified date: September 2020
• Source: University of South Alabama
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Refractory Partial Seizures
• Seizures

Intervention

Drug:
• Rufinamide
Rufinamide

Locations

Country	Name	City	State
United States	University of South Alabama	Mobile	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of South Alabama

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in total partial seizure frequency from baseline.		22 weeks