Safety Study of Rufinamide Given as an add-on Therapy to Treat Patients With Seizures
A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2006
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 15, 2020
CompletedFirst Posted
Study publicly available on registry
September 22, 2020
CompletedSeptember 22, 2020
September 1, 2020
2.7 years
September 15, 2020
September 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage change in total partial seizure frequency from baseline.
22 weeks
Study Arms (2)
Standard of Care
NO INTERVENTIONRufinamide
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of South Alabama
Mobile, Alabama, 36693, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Maertens, MD
University of South Alabama
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2020
First Posted
September 22, 2020
Study Start
April 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
September 22, 2020
Record last verified: 2020-09