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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Refractory Partial Seizures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Rufinamide

Group Type EXPERIMENTAL

Rufinamide

Intervention Type DRUG

Rufinamide

Interventions

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Rufinamide

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No