Clinical trials: sponsored by Eisai Inc.
Healthy
Evaluation of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of E2609 in Healthy Subjects
The purpose of this single-center, randomized, double-blind, placebo-controlled, study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when administered to healthy elderly subjects.
- Trial name
- NCT01511783
- Testing
- E2609
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Subjects
A Study to Evaluate the Effects of E2609 on QTc Interval in Healthy Subjects
This thorough QT (TQT) study will take place in healthy subjects administered single doses of study drug. It will be a randomized, double-blind, placebo and active-controlled, 4-treatment crossover study.
- Trial name
- NCT02222324
- Testing
- E2609, Moxifloxacin
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Epilepsy
E2007 Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
The primary objective of this study is to determine the maximal tolerated dose (MTD) of E2007 given twice daily (bid) or once a day (qd) in patients with refractory partial-onset seizures (including secondarily generalized…
- Trial name
- NCT00144690
- Testing
- E2007 (perampanel)
- Where
- 5 sites in United States
- 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.
Healthy Subjects
A 3-Part, Open-Label, Drug-Drug Interaction Study of Concomitant Administration of E2609 With Itraconazole, Rifampin, Digoxin, or Donepezil
This study will be a single-center, open-label, drug-drug interaction study in healthy male and female subjects. The study will consist of 3 parts: A, B, and C.
- Trial name
- NCT02055703
- Testing
- E2609, itraconazole, rifampin
- Where
- United States
- Volunteers
- 195 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.
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.
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 Volunteers
A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 in Healthy Japanese and White Subjects
This study will be a single-center, multiple-dose, randomized, double-blind, placebo-controlled, parallel-group study in healthy male and female subjects.
- Trial name
- NCT02039089
- Testing
- E2006 2.5 mg, E2006 10 mg, E2006 25 mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Myelodysplastic Syndrome
A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome
The purpose of this study was to determine which of the doses of decitabine maximizes genomic demethylation in patients with Myelodysplastic Syndrome (MDS).
- Trial name
- NCT00282399
- Testing
- Subcutaneous Decitabine
- Where
- 3 sites in United States
- Volunteers
- 41 people
- Sponsor
- Eisai Inc.
Partial Onset Seizures
A Post-marketing Study Evaluating Eslicarbazepine Acetate (ESL) as Adjunctive Treatment in Partial-Onset Seizures (Study E2093-E044-404) (EPOS)
This was a Non-interventional Prospective Study. Centres enrolled adult patients with partial-onset seizures with or without secondary generalisation for whom the clinician had decided to initiate Eslicarbazepine Acetate (ESL) as…
- Trial name
- NCT01830400
- Testing
- Eslicarbazepine Acetate tablets
- Where
- 106 sites in Czechia, Denmark and 6 more
- Volunteers
- 254 people
- Sponsor
- Eisai Inc.
Solid Tumor Malignancies, Cancer
An Open-Label Study of E7974 Administered on Days 1, 8, and 15 of a 28-Day Cycle and Days 1 and 8 of a 21-Day Cycle in Patients With Solid Malignancies
The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 administered as an intravenous bolus dose on Days 1, 8, and 15 of a 28-day cycle (Arm A) or on Days 1 and 8 of a 21-day cycle (Arm B) to patients…
- Trial name
- NCT00121732
- Testing
- E7974
- Where
- 2 sites in United States
- Volunteers
- 39 people
- Sponsor
- Eisai Inc.
Cancer, Malignant Tumors
A Phase 1 Open-Label Study of E7974 Administered on Days 1 and 15 of a 28-Day Cycle in Patients With Solid Malignancies
The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 administered on Days 1 and 15 of a 28-day cycle in subjects with solid malignancies that have progressed following effective therapy or for which…
- Trial name
- NCT00130169
- Testing
- E7974
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Eisai Inc.
Migraine Prophylaxis
Efficacy and Safety Study of E2007 in Migraine Prophylaxis
This was a 22-week, prospective, randomized, double-blind, placebo-controlled, multicenter, parallel-group study that included a 4-week Baseline Phase at the beginning and a 4-week single-blind placebo Safety Phase at the end of…
- Trial name
- NCT00154063
- Testing
- E2007
- Where
- 9 sites in United States
- Volunteers
- 206 people
- Sponsor
- Eisai Inc.
Parkinson's Disease
A Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor Fluctuations
This is a randomized, double-blind, two treatment, two group, parallel group study. Subjects will be randomized to one of two treatment groups (E2007 or Placebo) in a 3 to 1 ratio and receive treatment for a total of ten weeks…
- Trial name
- NCT00165789
- Testing
- E2007
- Where
- 10 sites in United States
- Volunteers
- 75 people
- Sponsor
- Eisai Inc.
Metastatic Breast Cancer
An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer Refractory
This expanded access program is an open-label, multi-center study, which will consist of a PreTreatment Phase and a Treatment Phase.
- Trial name
- NCT01240421
- Testing
- Eribulin Mesylate
- Where
- 14 sites in Belgium, Canada and 1 more
- Sponsor
- Eisai Inc.
Hepatic Impairment, Hepatic Function
A Pharmacokinetic and Safety Study of E7080 in Subjects With Mild (10 mg), Moderate (10 mg), and Severe Hepatic Impairment (5 mg) and Normal Hepatic Function (10 mg)
This is a multi-center, open-label, non-randomized, single-dose, sequential-cohort study in subjects with varying degrees of hepatic impairment, classified according to the Child-Pugh system, who will be matched with normal…
- Trial name
- NCT02421042
- Testing
- Lenvatinib
- Where
- 5 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Renal Impairment, Disease Severity
A Phase 1, Open-Label, Single-Dose, Pharmacokinetic and Safety Study of E7080 (24 mg) Administered to Subjects With Mild, Moderate, and Severe Renal Impairment and to Healthy Subjects
The purpose of this multicenter, open-label, non-randomized, single, oral dose, sequential-cohort study was to determine pharmacokinetics and safety of lenvatinib (24 mg) administered to healthy subjects and to subjects with…
- Trial name
- NCT02199379
- Testing
- Lenvatinib
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Acute Myelogenous Leukemia (AML)
A Randomized Study of Epigenetic Priming Using Decitabine With Front Line Induction Chemotherapy Compared With Immediate Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects
The purpose of this study is to evaluate the efficacy and safety of decitabine when used before chemotherapy to treat leukemia in pediatric patients.
- Trial name
- NCT00943553
- Testing
- decitabine Induction Chemotherapy, Induction Chemotherapy
- Where
- India
- Sponsor
- Eisai Inc.
Cancer
E7080 Food Effect Study in Healthy Subjects
This will be a randomized, single-dose, open-label, two-period crossover study in 16 healthy subjects. The study will consist of two phases: Pre-randomization and Randomization.
- Trial name
- NCT01240408
- Testing
- HOPE
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.