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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.
 
ClinicalTrials.gov Identifier: NCT04558580
Recruitment Status : Withdrawn
First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
University of South Alabama

Tracking Information
First Submitted Date  ICMJE September 15, 2020
First Posted Date  ICMJE September 22, 2020
Last Update Posted Date September 22, 2020
Actual Study Start Date  ICMJE April 2006
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
Percentage change in total partial seizure frequency from baseline. [ Time Frame: 22 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Rufinamide Given as an add-on Therapy to Treat Patients With Seizures
Official Title  ICMJE A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Refractory Partial Seizures
Intervention  ICMJE Drug: Rufinamide
Rufinamide
Study Arms  ICMJE
  • No Intervention: Standard of Care
  • Experimental: Rufinamide
    Intervention: Drug: Rufinamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 15, 2020)
0
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04558580
Other Study ID Numbers  ICMJE E2080-A001-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of South Alabama
Study Sponsor  ICMJE University of South Alabama
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul Maertens, MD University of South Alabama
PRS Account University of South Alabama
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP