Clinical trials: sponsored by Eisai Inc.
P-glycoprotein, Healthy Volunteers
A Pharmacokinetic Study to Assess the Influence of P-glycoprotein Inhibition and Simultaneous CYP3A4 and P-glycoprotein Induction on E7080 Pharmacokinetics Following Single Dose Oral Administration of 24 mg E7080 to Healthy Volunteers
The purpose of this single-dose, open-label, sequential, three-period study in 15 healthy subjects was to assess the influence of P-glycoprotein inhibition and simultaneous CYP3A4 and P-glycoprotein induction on lenvatinib…
- Trial name
- NCT02199392
- Testing
- Lenvatinib
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Pharmacokinetic Study to Assess the Influence of Simultaneous CYP3A4 and P-glycoprotein Inhibition on E7080 Pharmacokinetics Following Single Dose Oral Administration of 5 mg E7080 to Healthy Volunteers
The purpose of this study is to assess the influence of simultaneous CYP3A4 and p-glycoprotein inhibition on lenvatinib pharmacokinetics following a single oral dose of 5 mg lenvatinib.
- Trial name
- NCT02198170
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Epilepsy, Partial
To Evaluate the Effect of Perampanel on Objective and Subjective Sleep in Subjects With Insomnia and Partial Onset Seizures
This will be a multi-center, randomized, double-blind, placebo-controlled, crossover study to evaluate the effects of 2007/Fycompa (perampanel) on sleep, in subjects with well controlled partial onset seizures (on an…
- Trial name
- NCT02220972
- Testing
- Perampanel
- Sponsor
- Eisai Inc.
Cancer
Access Program With Denileukin Diftitox for the Treatment of Patients Currently Receiving Treatment With Commercially Available (Ontak)
The purpose of this study is to provide continued therapy with Denileukin diftitox (ONTAK) to patients who are currently on therapy and who have no other suitable treatment options, where therapy is requested by their physician.
- Trial name
- NCT01432483
- Testing
- Denileukin diftitox (ONTAK)
- Sponsor
- Eisai Inc.
Arthroscopy, Bunionectomy
A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Minor Surgical Procedures
The purpose of this study is to determine the safety, tolerability, and efficacy of AQUAVAN® Injection when used for mild-to-moderate sedation in patients undergoing minor surgical procedures.
- Conditions
- Arthroscopy, Bunionectomy, Osteotomy, Carpal Tunnel
- Trial name
- NCT00209560
- Testing
- fospropofol disodium
- Volunteers
- 168 people
- Sponsor
- Eisai Inc.
Neoplasms, Lymphoma, Malignant
Dosing and Safety Study of E7820 in Patients With a Malignant Solid Tumor or Lymphoma
This is a first-in-man, open-label, non-randomized, multiple dose, multiple cycle, dose escalation study to determine the MTD, safety, PK, and pharmacodynamics of E7820 in patients with a malignant solid tumor or lymphoma.
- Trial name
- NCT00078637
- Testing
- E7820
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Eisai Inc.
Thrombocytopenia
A Five-Treatment-Period Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of Avatrombopag in Healthy Japanese and White Subjects
This will be a randomized, open-label, 5-treatment-period study to evaluate the PK and PD of avatrombopag following a single administration of avatrombopag in the fed and fasted condition, or the fed condition, to healthy…
- Trial name
- NCT02039076
- Testing
- avatrombopag
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Myelodysplastic Syndromes
To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.
The purpose of this study is to compare the response of patients with Intermediate or High Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.
- Trial name
- NCT01011283
- Testing
- decitabine, azacitidine
- Where
- 19 sites in United States
- Volunteers
- 26 people
- Sponsor
- Eisai Inc.
Partial Seizures
Evaluating the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures
The objectives of this trial are to evaluate the safety and efficacy of Zonisamide as adjunctive therapy in medically refractory patients receiving other antiepileptic drugs (AEDs).
- Trial name
- NCT00327717
- Testing
- Zonisamide
- Where
- 8 sites in China
- Volunteers
- 240 people
- Sponsor
- Eisai Inc.
Alzheimer's Type Dementia
A Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia
The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with severe Alzheimer's disease.
- Trial name
- NCT01276353
- Testing
- E2020
- Where
- 11 sites in Japan
- Volunteers
- 45 people
- Sponsor
- Eisai Inc.
Prostate Cancer
Evaluating E7389 in Patients With Hormone Refractory Prostate Cancer With Advanced and/or Metastatic Disease Stratified by Prior Chemotherapy
This is a multi-centre, phase II, open-label, two-stage design, single-arm study in patients with hormone-refractory prostate cancer (HRPC) with advanced (rising PSA) and/or metastatic disease and who have had prior anti-androgen…
- Trial name
- NCT00278993
- Testing
- E7389
- Where
- 18 sites in United States
- Volunteers
- 108 people
- Sponsor
- Eisai Inc.
Partial Seizures
Evaluation of the Efficacy and Safety of Adjunctive Zonisamide vs Replacement With Zonisamide of the Last Added Antiepileptic Drug
An open-label, randomized, multi-centre, superiority study to assess that, in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapy, the triple therapy is superior to the…
- Trial name
- NCT01630057
- Testing
- Adjunctive Zonisamide, Replacement with Zonisamide
- Where
- 19 sites in Italy
- Volunteers
- 200 people
- Sponsor
- Eisai Inc.
Alzheimer's Disease
Hippocampus Study: Comparative Effect of Donepezil 10mg/d and Placebo on Clinical and Radiological Markers
The purpose of this study is to demonstrate that donepezil slows the progression of Alzheimer's disease (AD) using magnetic resonance imaging (MRI) of the brain to measure the volume of the hippocampus in patients with…
- Trial name
- NCT00403520
- Testing
- Experimental 1
- Where
- France
- Volunteers
- 240 people
- Sponsor
- Eisai Inc.
Breast Cancer
A Phase II Study of E7389 in Patients With Breast Cancer, Previously Treated With Anthracycline, Taxane and Capecitabine
The purpose of this study is to evaluate the efficacy and safety of E7389 in Patients with locally advanced or metastatic breast cancer, previously treated with anthracycline, taxane, and capecitabine as prior therapy, and who…
- Trial name
- NCT00246090
- Testing
- E7389
- Where
- 65 sites in United States, Canada
- Volunteers
- 298 people
- Sponsor
- Eisai Inc.
Healthy Subjects
Randomized, Placebo-controlled Study to Evaluate Effects of E5555 on Renal Function Parameters and OCT2 Activity
This is a drug-drug interaction study to evaluate the effects of steady-state exposure of E5555 and its main metabolites on the pharmacokinetics (PK) of metformin, an organic cation transporter-2 (OCT2) substrate.
- Trial name
- NCT01241669
- Testing
- E5555
- Where
- United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Alzheimer's Disease
Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease
The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with moderate to severe Alzheimer's disease.
- Trial name
- NCT00478205
- Testing
- Aricept (donepezil SR 23 mg), Aricept (donepezil IR 10 mg)
- Where
- United States
- Volunteers
- 1,467 people
- Sponsor
- Eisai Inc.
Parkinson's Disease
A Study of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
Patients who have completed one of the core trials (E2007-E044-301 or E2007-A001-302) and who meet inclusion/exclusion criteria will be enrolled and will enter the Titration Phase, lasting 4 weeks (weeks 0-3) followed by the…
- Trial name
- NCT00360412
- Testing
- E2007
- Where
- Germany
- Volunteers
- 997 people
- Sponsor
- Eisai Inc.
Leukemia
A Study of Eritoran (E5564) Administered IV Over 14 Days Prior to and During Bone Marrow Engraftment in BMT Patients Who Have Received Myeloablative Conditioning Treatment and Are Receiving Bone Marrow or Stem Cells From Matched Related Donors
This is a study designed to assess the safety of administration of up to 3 dose levels of eritoran in subjects undergoing or scheduled to undergo allogeneic bone marrow transplant (BMT).
- Trial name
- NCT00756912
- Testing
- E5564
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Eisai Inc.
Healthy Subjects
A Study to Evaluate the Effects of Diltiazem, a Moderate CYP3A4/A5 Inhibitor, on the Pharmacokinetics and Pharmacodynamics of E5555 and Its Metabolites in Healthy Subjects
The purpose of this study is to evaluate the effects of diltiazem on the pharmacokinetics (PK) and pharmacodynamics (PD) of E5555 and its metabolites in healthy subjects.
- Trial name
- NCT01261156
- Testing
- E5555 100 mg and diltiazem, E5555 300 mg and diltiazem
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Refractory Partial Seizures
To Evaluate The 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
- NCT00699582
- Testing
- E2007 (perampanel)
- Where
- 92 sites in United States, Austria and 12 more
- Volunteers
- 389 people
- Sponsor
- Eisai Inc.