CLINICAL TRIALS PROFILE FOR RUFINAMIDE

All Clinical Trials for rufinamide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00334958 ↗	Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures	Completed	Eisai Inc.	Phase 3	2006-02-13	To evaluate the effect of rufinamide on total partial seizure frequency in adolescent and adult participants (12 to 80 years, inclusive) with refractory partial onset seizures maintained on a maximum of 3 stable antiepileptic drugs (AEDs).
NCT00448539 ↗	Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures	Terminated	Eisai Inc.	Phase 3	2007-03-15	This was an open-label extension study in adolescent and adult (between 12 and 80 years old) participants who had completed their participation in Study E2080-A001-301. The main objective of this study was to evaluate the safety and efficacy of long-term administration of rufinamide for the control of epileptic seizures in participants who had refractory partial seizures despite treatment with a maximum of three approved antiepileptic drugs (AEDs).
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	A Multi-Centered Randomized, Double-Blind, Placebo-Controlled, Phase 2, Exploratory Study to Evaluate the Effect of Rufinamide on Anxiety in Patients with Moderate to Severe Generalized Anxiety Disorder.
NCT00595231 ↗	Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD)	Completed	Syneos Health	Phase 2	2008-03-01	A Multi-Centered Randomized, Double-Blind, Placebo-Controlled, Phase 2, Exploratory Study to Evaluate the Effect of Rufinamide on Anxiety in Patients with Moderate to Severe Generalized Anxiety Disorder.
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	A Multi-Centered Randomized, Double-Blind, Placebo-Controlled, Phase 2, Exploratory Study to Evaluate the Effect of Rufinamide on Anxiety in Patients with Moderate to Severe Generalized Anxiety Disorder.
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.
NCT01151540 ↗	A Long Term Extension Study of E2080 in Lennox-Gastaut Patients	Completed	Eisai Co., Ltd.	Phase 3	2010-11-01	To investigate the safety of long term administration of E2080 in the patients with Lennox-Gastaut syndrome who completed the E2080-J081-304 Study.

Clinical Trial Conditions for rufinamide

Condition Name

Condition Name for rufinamide
Intervention	Trials
Lennox-Gastaut Syndrome	4
Epilepsy	2
Generalized Anxiety Disorder	1
Healthy Subjects	1

Condition MeSH

Condition MeSH for rufinamide
Intervention	Trials
Lennox Gastaut Syndrome	4
Seizures	4
Syndrome	3
Disease	1

Clinical Trial Locations for rufinamide

Trials by Country

Trials by Country for rufinamide
Location	Trials
United States	66
Japan	39
Italy	5
Canada	3
Switzerland	2

Trials by US State

Trials by US State for rufinamide
Location	Trials
Georgia	4
Ohio	4
Illinois	3
Florida	3
Alabama	3

Clinical Trial Progress for rufinamide

Clinical Trial Phase

Clinical Trial Phase for rufinamide
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	6
Phase 2	2

Clinical Trial Status

Clinical Trial Status for rufinamide
Clinical Trial Phase	Trials
Completed	7
Withdrawn	2
Unknown status	1

Clinical Trial Sponsors for rufinamide

Sponsor Name

Sponsor Name for rufinamide
Sponsor	Trials
Eisai Inc.	3
Eisai Co., Ltd.	2
University of Zurich	2

Sponsor Type

Sponsor Type for rufinamide
Sponsor	Trials
Other	23
Industry	7