Clinical trials: sponsored by Eisai Inc.
Acute Coronary Syndrome
Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Acute Coronary Syndrome
This is a multi-center, randomized, double-blind, placebo-controlled study to determine the safety and tolerability of E5555 in subjects with Acute coronary syndrome (ACS).
- Trial name
- NCT00548587
- Testing
- E5555
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 600 people
- Sponsor
- Eisai Inc.
Symptomatic Gastroesophageal Reflux Disease (sGERD)
Comparing the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)
The purpose of this study is to compare the efficacy, safety and tolerability of rabeprazole extended release (ER) 50 mg with placebo in subjects with symptomatic gastroesophageal reflux disease (sGERD).
- Trial name
- NCT00911534
- Testing
- rabeprazole sodium
- Where
- 98 sites in United States
- Volunteers
- 305 people
- Sponsor
- Eisai Inc.
Cancer
A Dose-Finding Study of E7050 Administered Orally to Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum tolerated dose (MTD) of E7050 given orally in patients with advanced solid tumors.
- Trial name
- NCT00869895
- Testing
- E7050
- Where
- 2 sites in United Kingdom
- Volunteers
- 60 people
- Sponsor
- Eisai Inc.
Neuralgia
Evaluating E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN)
The purpose of this study is to evaluate the safety, tolerability and continued efficacy of perampanel in patients previously enrolled in double-blind, placebo-controlled studies for Painful Diabetic Neuropathy (PDN) or…
- Trial name
- NCT00592904
- Testing
- E2007
- Where
- United States
- Volunteers
- 262 people
- Sponsor
- Eisai Inc.
Refractory Partial Seizures
Evaluating Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.
- Trial name
- NCT00700310
- Testing
- perampanel
- Where
- 137 sites in Australia, Bulgaria and 21 more
- Volunteers
- 712 people
- Sponsor
- Eisai Inc.
Prostate Cancer
Study of Irofulven in Patients With Hormone-refractory Prostate Cancer
The purpose of this study is to assess the efficacy and safety of irofulven-based regimens compared to mitoxantrone plus prednisone in patients with hormone-refractory prostate cancer (HRPC) whose disease has progressed following…
- Trial name
- NCT00124566
- Testing
- Irofulven, Prednisone, Mitoxantrone
- Where
- 50 sites in United States, Brazil and 7 more
- Volunteers
- 135 people
- Sponsor
- Eisai Inc.
Metabolism and Elimination
An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male Subjects
This is an open-label, single dose study in healthy male subjects.
- Trial name
- NCT01975636
- Testing
- E2609
- Where
- 2 sites in United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Epilepsy
A Double-blind Study to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy
This is a two-arm, randomized, double-blind, non-inferiority study using a flexible dosing regime to allow optimal zonisamide or carbamazepine therapy for individual subjects.
- Trial name
- NCT00477295
- Testing
- Zonisamide, Carbamazepine
- Where
- 79 sites in Australia, Denmark and 16 more
- Volunteers
- 583 people
- Sponsor
- Eisai Inc.
Epilepsy
Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures
The purpose of this study is to assess the long-term safety and tolerability and to explore the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly diagnosed partial seizures.
- Trial name
- NCT00848549
- Testing
- Zonisamide, Carbamazepine
- Where
- 133 sites in Australia, Denmark and 18 more
- Volunteers
- 295 people
- Sponsor
- Eisai Inc.
Gastroesophageal Reflux Disease (GERD)
Rabeprazole Extended-Release, 50 mg, Versus Esomeprazole, 40 mg, for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
The purpose of this study is to investigate the efficacy (ie, healing and symptom relief) and safety of Rabeprazole Extended-Release (RAB ER) 50 mg versus Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive…
- Trial name
- NCT00658775
- Testing
- Rabeprazole sodium, Esomeprazole
- Where
- 83 sites in United States, Argentina and 12 more
- Volunteers
- 1,069 people
- Sponsor
- Eisai Inc.
Gastroesophageal Reflux Disease (GERD)
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease…
- Trial name
- NCT00658528
- Testing
- Rabeprazole sodium, Esomeprazole
- Where
- 88 sites in United States, Argentina and 11 more
- Volunteers
- 1,061 people
- Sponsor
- Eisai Inc.
Metastatic Melanoma
A Phase I/Ib, Multicenter, Open-Label, Dose Escalation Study of E7080 in Patients With Solid Tumors and in Combination With Temozolomide in Patients With Advanced and/or Metastatic Melanoma
The purpose of this study is to study the safety of E7080 administered to patients with solid tumors or lymphomas. Please note: this study is now recruiting patients with advanced and/or metastatic melanoma only.
- Trial name
- NCT00121680
- Testing
- E7080
- Where
- 2 sites in United States
- Volunteers
- 115 people
- Sponsor
- Eisai Inc.
Epilepsy
4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures
The purpose of this study is to determine the safety of perampanel given as adjunctive, long-term treatment in patients with refractory partial onset seizures.
- Trial name
- NCT00368472
- Testing
- Perampanel
- Where
- 47 sites in United States, Australia and 12 more
- Volunteers
- 138 people
- Sponsor
- Eisai Inc.
Crohn's Disease
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's Disease
This is a multicenter, Phase 1b, randomized, double-blind, placebo-controlled, sequential-cohort, multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of 3…
- Trial name
- NCT02249078
- Testing
- E6011
- Sponsor
- Eisai Inc.
Healthy Subjects
A Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects
This is an open-label, 2-arm, single-dose, randomized crossover study. The study will enroll a total of 100 subjects (2 arms with 50 subjects in each arm).
- Trial name
- NCT02279485
- Testing
- Perampanel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Lactating Women
A Study to Assess the Transfer of Fospropofol and Its Active Metabolite, Propofol, to Breast Milk Following Administration of LUSEDRA to Lactating Women Undergoing a Needed Procedure
The purpose of this study is to assess the transfer of fospropofol and its active metabolite, propofol, to breast milk following administration of LUSEDRA® to lactating women undergoing a needed procedure.
- Trial name
- NCT01309984
- Testing
- Lusedra, Propofol
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Eisai Inc.
Monitored Anesthesia Care
A Study to Characterize Pharmacokinetics (PK) and Pharmacodynamics (PD) of LUSEDRA® Administered as Continuous Infusion or Bolus Compared With Continuous Infusion of Propofol Injectable Emulsion
The purpose of this study is to explore the pharmacokinetics (PK) and pharmacodynamics (PD) of LUSEDRA® administered as a continuous infusion or bolus compared with continuous infusion of propofol injectable emulsion.
- Trial name
- NCT01308541
- Testing
- arm 1, LUSEDRA, Propofol (arm 3)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Subjects
A 2-Part Study to Assess Potential Metabolism-Based Drug-Drug Interactions of E2006 When Coadministered With Itraconazole, Rifampin, Midazolam, or Bupropion
This study will be a single center, open-label, drug-drug interaction study in healthy male and female subjects. The study will consist of 2 parts.
- Trial name
- NCT02085967
- Testing
- rifampin 600 mg, itraconazole 200 mg, midazolam 2 mg with bupropion 75 mg
- Where
- United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Subjects
A Study to Determine the Effect of a High-Fat Meal on the Rate and Extent of E2006 Absorption in Healthy Subjects
This is an open-label, single-dose, randomized crossover study of single oral 10-mg tablet doses administered either after an overnight fast or in combination with a standard high-fat meal in healthy subjects.
- Trial name
- NCT02089412
- Testing
- E2006
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Parkinson's Disease, Dementia
Safety, Tolerability, and Efficacy of Donepezil (Aricept) in Parkinson' s Disease (PD) Patients With Dementia
The purpose of this study is to evaluate the safety, tolerability, and efficacy of donepezil (Aricept) in Parkinson's Disease (PD) patients with dementia.
- Trial name
- NCT01327859
- Testing
- Prior Donepezil 5mg, Prior Donzepezil 10mg
- Where
- United Kingdom
- Volunteers
- 357 people
- Sponsor
- Eisai Inc.