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

Primary Purpose

Refractory Partial Seizures

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rufinamide
Sponsored by
University of South Alabama
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Partial Seizures focused on measuring Seizure, Seizures, Epilepsy

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of South Alabama

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Rufinamide

Arm Description

Outcomes

Primary Outcome Measures

Percentage change in total partial seizure frequency from baseline.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2020
Last Updated
September 15, 2020
Sponsor
University of South Alabama
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1. Study Identification

Unique Protocol Identification Number
NCT04558580
Brief Title
Safety Study of Rufinamide Given as an add-on Therapy to Treat Patients With Seizures
Official Title
A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Study Start Date
April 2006 (Actual)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Alabama

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Partial Seizures
Keywords
Seizure, Seizures, Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Title
Rufinamide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rufinamide
Intervention Description
Rufinamide
Primary Outcome Measure Information:
Title
Percentage change in total partial seizure frequency from baseline.
Time Frame
22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Maertens, MD
Organizational Affiliation
University of South Alabama
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36693
Country
United States

12. IPD Sharing Statement

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

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