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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR RUFINAMIDE

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Clinical Trials for Rufinamide

Trial ID Title Status Sponsor Phase Summary
NCT00334958 Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures Completed Eisai Inc. Phase 3 The primary objective of this study is to evaluate the effect of rufinamide on total partial seizure frequency in adolescent and adult patients with refractory partial onset seizures currently inadequately treated with a maximum of three stable antiepileptic medications. Secondary objectives are to evaluate the effect of rufinamide on secondary and exploratory outcomes, to confirm the safety profile of rufinamide, and to assess the relationship between rufinamide plasma concentration and efficacy.
NCT00448539 Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures Completed Eisai Inc. Phase 3 This study is an open-label extension of Study E2080-A001-301. All patients will initiate the study at the total daily doses they were receiving at the end of the transition phase in E2080-A001-301 (2400 or 3200 mg/day) with an option, at the discretion of the Investigator, to incrementally increase doses to a maximum of 4800 mg/day. Safety variables and seizure frequency will be monitored throughout the study.
NCT00595231 Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD) Completed INC Research Phase 2 This is an eight week, randomized, double blind, placebo-controlled, exploratory study. Patients randomized to rufinamide (SYN111) will receive 250 mg BID (total daily dose 500mg) for one week then have their dose increased to 500 mg BID (total daily dose 1000mg) for the remaining 7 weeks of the study. If the 500 mg BID dose is not tolerated, one dose reduction is allowed.
NCT00595231 Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD) Completed Biotie Therapies Inc. Phase 2 This is an eight week, randomized, double blind, placebo-controlled, exploratory study. Patients randomized to rufinamide (SYN111) will receive 250 mg BID (total daily dose 500mg) for one week then have their dose increased to 500 mg BID (total daily dose 1000mg) for the remaining 7 weeks of the study. If the 500 mg BID dose is not tolerated, one dose reduction is allowed.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Rufinamide

Condition Name

Condition Name for Rufinamide
Intervention Trials
Lennox-Gastaut Syndrome 3
Epilepsy 2
Pain 1
Healthy Subjects 1
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Condition MeSH

Condition MeSH for Rufinamide
Intervention Trials
Syndrome 3
Lennox Gastaut Syndrome 3
Seizures 3
Disease 1
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Clinical Trial Locations for Rufinamide

Trials by Country

Trials by Country for Rufinamide
Location Trials
United States 56
Japan 20
Italy 4
Switzerland 2
Poland 1
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Trials by US State

Trials by US State for Rufinamide
Location Trials
Ohio 4
Florida 3
Texas 3
Georgia 3
Illinois 2
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Clinical Trial Progress for Rufinamide

Clinical Trial Phase

Clinical Trial Phase for Rufinamide
Clinical Trial Phase Trials
Phase 4 2
Phase 3 4
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Rufinamide
Clinical Trial Phase Trials
Completed 7
Recruiting 2
Withdrawn 1
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Clinical Trial Sponsors for Rufinamide

Sponsor Name

Sponsor Name for Rufinamide
Sponsor Trials
Eisai Inc. 3
University of Zurich 2
Wuhan Union Hospital, China 1
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Sponsor Type

Sponsor Type for Rufinamide
Sponsor Trials
Other 15
Industry 6
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