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Last Updated: September 23, 2021

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CLINICAL TRIALS PROFILE FOR RUFINAMIDE

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All Clinical Trials for Rufinamide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00334958 ↗ Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures Completed Eisai Inc. Phase 3 2006-02-01 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 2007-03-01 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 2008-03-01 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 2008-03-01 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.
NCT01146951 ↗ A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304) Completed Eisai Limited Phase 3 2010-06-01 To confirm that the combination therapy of rufinamide has superior efficacy compared to placebo in patients with Lennox-Gastaut syndrome.
NCT01212458 ↗ Effect of Oral Rufinamide and Oxcarbazepine on Nerve Excitability, Hyperalgesia, Allodynia and Flare Reaction Compared to Placebo. A Monocenter, Randomized, Double-blind, Cross-over Study Completed University of Zurich Phase 4 2010-10-01 Untersuchungen über die Wirkmechanismen von Antiepileptika haben gezeigt, dass durch eine Blockierung von spannungsabhängigen Natrium-Kanälen im Nervensystem die Schmerzübertragung moduliert werden kann. Verschiedene Antiepileptika werden in der chronischen Schmerztherapie schon lange angewendet (z.B. Oxcarbazepinum, Trileptal ® bei Trigeminusneuralgie oder diabetischer Polyneuropathie). In unserer Untersuchung wollen wir zwei in der Schweiz zugelassene Antiepileptika bezüglich ihrer Wirkung auf das Schmerzempfinden untersuchen. Eines dieser Medikamente, Trileptal® (Wirkstoff: Oxcarbazepinum), wird schon häufig bei chronischen Schmerzzuständen eingesetzt. Das zweite Medikament, Inovelon® (Wirkstoff: Rufinamid) ist seit mehr als einem Jahr in der Schweiz zugelassen und wird klinisch vor allem in der Behandlung von besonderen Epilepsieformen im Kindesalter eingesetzt. Wir erwarten, dass auch nach Gabe von Inovelon® die Schmerzleitung in den Nervenzellen verändert und die lokalen Schmerzreaktionen in der Haut vermindert werden. - Trial with medicinal product
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Rufinamide

Condition Name

Condition Name for Rufinamide
Intervention Trials
Lennox-Gastaut Syndrome 3
Epilepsy 2
Refractory Partial Seizures 1
Refractory Partial Onset Seizures 1
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Condition MeSH

Condition MeSH for Rufinamide
Intervention Trials
Seizures 4
Lennox Gastaut Syndrome 3
Syndrome 3
Disease 1
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Clinical Trial Locations for Rufinamide

Trials by Country

Trials by Country for Rufinamide
Location Trials
United States 57
Japan 20
Italy 4
Switzerland 2
United Kingdom 1
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Trials by US State

Trials by US State for Rufinamide
Location Trials
Ohio 4
Florida 3
Alabama 3
Texas 3
Georgia 3
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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 5
Phase 2 2
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Clinical Trial Status

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

Sponsor Name

Sponsor Name for Rufinamide
Sponsor Trials
Eisai Inc. 3
University of Zurich 2
University College, London 1
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Sponsor Type

Sponsor Type for Rufinamide
Sponsor Trials
Other 16
Industry 6
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