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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04558580
Recruitment Status : Withdrawn
First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Refractory Partial Seizures Drug: Rufinamide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
Actual Study Start Date : April 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Rufinamide

Arm Intervention/treatment
No Intervention: Standard of Care
Experimental: Rufinamide Drug: Rufinamide

Primary Outcome Measures :
  1. Percentage change in total partial seizure frequency from baseline. [ Time Frame: 22 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04558580

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United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36693
Sponsors and Collaborators
University of South Alabama
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Principal Investigator: Paul Maertens, MD University of South Alabama
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Responsible Party: University of South Alabama Identifier: NCT04558580    
Other Study ID Numbers: E2080-A001-301
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Keywords provided by University of South Alabama:
Seizure, Seizures, Epilepsy
Additional relevant MeSH terms:
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Neurologic Manifestations
Nervous System Diseases
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action