Clinical trials: sponsored by Eisai Inc.
Cardiovascular Disease, High Cardiovascular Risk
A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in overweight and obese subjects with cardiovascular (CV) disease and/or multiple CV risk factors.
- Conditions
- Cardiovascular Disease, High Cardiovascular Risk, Obesity, Overweight
- Trial name
- CAMELLIA-TIMI (NCT02019264)
- Testing
- Lorcaserin hydrochloride
- Where
- 499 sites in United States, Australia and 6 more
- Volunteers
- 14,673 people
- Sponsor
- Eisai Inc.
Epilepsy
A Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics in Adolescents
This study is designed to investigate the short- and long-term effects of perampanel on cognition, growth, and development in adolescents.
- Trial name
- NCT01161524
- Testing
- Perampanel
- Where
- 37 sites in United States, Australia and 9 more
- Volunteers
- 133 people
- Sponsor
- Eisai Inc.
Epilepsy
Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy
This study is conducted to assess the retention rate of Fycompa when given in routine clinical care.
- Trial name
- NCT03208660
- Testing
- Fycompa
- Where
- 44 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Eisai Inc.
Healthy Volunteers
Bioequivalence Study to Evaluate the Impact of Varying Crystalline Polymorph Forms for the Commercial Oral Capsule Formulation of 10-mg Lenvatinib in Healthy Volunteers
This will be a randomized, single dose, open-label, three-treatment period crossover study in healthy participants to determine whether 2 test lots of 10-mg capsules that vary by the level of lenvatinib Type-C crystal are…
- Trial name
- NCT02723630
- Testing
- Lenvatinib 10 mg
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
Crossover Study to Evaluate the Relative Bioavailability and Palatability of a Lenvatinib Suspension Compared to the Capsule Formulation in Adult Healthy Volunteers
The study will be conducted in adult healthy participants and will consist of two phases: Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods: a Screening Period and a Baseline Period.
- Trial name
- NCT02792829
- Testing
- Lenvatinib
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Participants
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2730 in Healthy Participants
This study will be conducted to evaluate the safety, tolerability, and pharmacokinetics of single ascending oral doses of E2730 in healthy adult participants.
- Trial name
- NCT03451890
- Testing
- E2730
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Metastatic Renal Cell Carcinoma
A Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Treatment
This is an open-label, multicenter, Phase 1b/2 study of lenvatinib alone and in combination with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma following one prior VEGF-targeted treatment.
- Trial name
- NCT01136733
- Testing
- Lenvatinib, Everolimus
- Where
- 37 sites in United States, Czechia and 3 more
- Volunteers
- 173 people
- Sponsor
- Eisai Inc.
Mild to Moderate Diabetic Sensorimotor Polyneuropathy
Evaluating the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy
The purpose of this study is to determine the effect of 40 mg and 80 mg ranirestat on peroneal motor nerve conduction velocity relative to placebo in subjects with mild to moderate diabetic sensorimotor polyneuropathy.
- Trial name
- NCT00927914
- Testing
- Ranirestat
- Where
- United States
- Volunteers
- 800 people
- Sponsor
- Eisai Inc.
Pediatrics, Solid Tumors
This is a Phase 1 Study of Eribulin Mesylate in Pediatric Participants With Recurrent or Refractory Solid Tumors (Excluding [Central Nervous System] CNS), Including Lymphomas
This is a Phase 1 study of eribulin mesylate in pediatric participants with recurrent or refractory solid tumors (excluding CNS), including lymphomas.
- Trial name
- BOLD 113 (NCT02171260)
- Testing
- Eribulin Mesylate
- Where
- 18 sites in United States
- Volunteers
- 23 people
- Sponsor
- Eisai Inc.
Thyroid Cancer
Expanded Access Program With Lenvatinib for the Treatment of Differentiated Thyroid Cancer in Brazil
This is an Expanded Access Program to make lenvatinib available to participants with radioiodine-refractory differentiated thyroid cancer in Brazil.
- Trial name
- NCT03533361
- Testing
- Lenvatinib
- Where
- Brazil
- Sponsor
- Eisai Inc.
Breast Cancer
Study to Evaluate the Efficacy and Safety of Eribulin Mesylate Administered Biweekly (Q2W) for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer
This is a Phase 2, open-label, single arm, multicenter, 2-stage study of eribulin mesylate administered biweekly at 1.4 mg/m2 intravenously for the treatment of participants with HER2-negative metastatic breast cancer previously…
- Trial name
- NCT02481050
- Testing
- Eribulin Mesylate
- Where
- 12 sites in United States
- Volunteers
- 58 people
- Sponsor
- Eisai Inc.
Pulmonary Embolism
Post-marketing Study of Monteplase ("Cleactor") in Patients With Acute Pulmonary Embolism
To investigate PK and coagulating and fibrinolytic parameter profiles (PD) at the approved dose (13,750 - 27,500 IU/kg) in patients with acute pulmonary embolism accompanying hemodynamic instability.
- Trial name
- NCT00442234
- Testing
- Monteplase
- Where
- 2 sites in Japan
- Volunteers
- 5 people
- Sponsor
- Eisai Inc.
Healthy Subjects
Study of Lemborexant-Alcohol Interaction in Healthy Subjects
This study will be conducted to evaluate the effects on cognitive performance (Power of Attention domain) and postural stability of lemborexant in combination with alcohol versus lemborexant alone and versus alcohol alone in…
- Trial name
- NCT03483636
- Testing
- Lemborexant, Alcohol
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Participants
A Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen in Healthy Participants
The purpose of this study is to demonstrate the bioequivalence between lorcaserin XR tablets manufactured in Kawashima and lorcaserin XR tablets manufactured in Zofingen.
- Trial name
- NCT03627936
- Testing
- Lorcaserin manufactured at Zofingen, Lorcaserin manufactured at Kawashima
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Mild to Severe Alzheimer's Disease
The Effectiveness And Safety Of Donepezil Hydrochloride (E2020) In Subjects With Mild To Severe Alzheimer's Disease Residing In An Assisted Living Facility
This is a study to determine the effectiveness and safety of donepezil hydrochloride (E2020) used to treat residents of assisted living facilities diagnosed with mild, moderate, or severe stage Alzheimer's disease.
- Trial name
- NCT00571064
- Testing
- Donepezil HCl
- Where
- 36 sites in United States
- Volunteers
- 97 people
- Sponsor
- Eisai Inc.
Epilepsy
A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 Years
The purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel) as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.
- Trial name
- NCT02033902
- Testing
- Perampanel
- Where
- 42 sites in Austria, Belgium and 4 more
- Volunteers
- 500 people
- Sponsor
- Eisai Inc.
Healthy Subjects
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2027 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of multiple ascending oral doses of E2027 in healthy participants.
- Trial name
- NCT02873156
- Testing
- E2027
- Where
- United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Hepatic Impairment; Renal Impairment
Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Protein Binding
E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants.
- Trial name
- NCT02998775
- Testing
- Plasma Sampling
- Where
- 3 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Participants
Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2730
Study E2730-A001-001 is a first-in-human, sequential ascending single dose, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single oral dose of E2730 in healthy participants.
- Trial name
- NCT03054194
- Testing
- E2730
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Participants
Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E6742 in Healthy Adult Subjects
Study E6742-A001-001 is a randomized, double-blind, placebo-controlled, single ascending dose study conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending oral doses…
- Trial name
- NCT03082235
- Testing
- E6742
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.