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

September 15, 2020 updated by: University of South Alabama

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36693
        • University of South Alabama

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
Experimental: Rufinamide
Drug: Rufinamide
Rufinamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage change in total partial seizure frequency from baseline.
Time Frame: 22 weeks
22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Alabama

Investigators

  • Principal Investigator: Paul Maertens, MD, University of South Alabama

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 22, 2020

Study Record Updates

Last Update Posted (Actual)

September 22, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2080-A001-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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