Clinical trials: sponsored by Eisai Inc.
Healthy Volunteers
A Study to Assess the Safety and Tolerability of E2511 in Healthy Participants
The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of E2511 following single ascending oral doses in healthy adult and elderly participants.
- Trial name
- NCT04547361
- Testing
- E2511
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Thyroid Cancer
Study of Irofulven Plus Capecitabine in Patients With Advanced Thyroid Cancer
Irofulven is an investigational chemotherapeutic agent being studied in a variety of solid tumors. The purpose of this study is to assess the efficacy and safety of irofulven/capecitabine combination therapy in patients with…
- Trial name
- NCT00124527
- Testing
- Irofulven + capecitabine
- Where
- 10 sites in United States, Argentina and 4 more
- Volunteers
- 35 people
- Sponsor
- Eisai Inc.
Epilepsy
Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures
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…
- Trial name
- NCT00334958
- Testing
- Rufinamide
- Where
- 77 sites in United States
- Volunteers
- 356 people
- Sponsor
- Eisai Inc.
Advanced Solid Tumors
A Study of E7050 in Combination With E7080 in Participants With Advanced Solid Tumors (Dose Escalation) and in Participants With Recurrent Glioblastoma or Unresectable Stage III or Stage IV Melanoma After Prior Systemic Therapy (Expansion Cohort and Phase 2)
This is a multicenter, open-label, Phase 1b/2 study which will be conducted in two parts: a Phase 1b part comprising a dose escalation and an expansion cohort; and a Phase 2 part which will comprise two cohorts.
- Trial name
- NCT01433991
- Testing
- Golvatinib, Lenvatinib
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Eisai Inc.
Irregular Sleep-Wake Rhythm Disorder
Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia
This study will be conducted to determine the dose response of lemborexant (LEM) on the change from baseline in actigraphy-derived sleep-related parameters, wake-related parameters, and circadian-rhythm related parameters.
- Trial name
- NCT03001557
- Testing
- Lemborexant 2.5 mg, Lemborexant 5 mg, Lemborexant 10 mg
- Where
- 48 sites in United States, Japan and 1 more
- Volunteers
- 63 people
- Sponsor
- Eisai Inc.
Hepatocellular Carcinoma
E7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Participants With Hepatocellular Carcinoma
The purpose of this study is to determine whether patients with hepatocellular carcinoma who receive either E7050 administered with Sorafenib or Sorafenib alone experience greater benefit (cancer responds to treatment) when E7050…
- Trial name
- NCT01271504
- Testing
- Sorafenib
- Where
- 24 sites in United States, Belgium and 4 more
- Volunteers
- 102 people
- Sponsor
- Eisai Inc.
Down Syndrome
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (HCl) (Aricept) In Treating Cognitive Dysfunction Exhibited By Children With Down Syndrome
The purpose of this study is to determine whether donepezil HCl is effective and safe in improving cognitive dysfunction exhibited by children and adolescents with Down syndrome (DS).
- Trial name
- NCT00570128
- Testing
- Donepezil HCl
- Where
- 31 sites in United States
- Volunteers
- 129 people
- Sponsor
- Eisai Inc.
Insomnia
A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of Insomnia
The primary objective of the study is to evaluate the proportion of adult [greater than or equal to (>=) 18 years] participants with insomnia disorder taking zolpidem tartrate immediate release (ZOL-IR) or zolpidem tartrate…
- Trial name
- NCT04009577
- Testing
- LEM 5 mg, LEM 10 mg
- Where
- 17 sites in United States
- Volunteers
- 53 people
- Sponsor
- Eisai Inc.
Down Syndrome
Evaluating The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled Trial
The purpose of this study is to determine the safety of donepezil hydrochloride (Aricept) in children with Down syndrome who have finished the preceding 10-week, double-blind study of donepezil hydrochloride.
- Trial name
- NCT00675025
- Testing
- Donepezil hydrochloride (Aricept)
- Where
- 31 sites in United States
- Volunteers
- 117 people
- Sponsor
- Eisai Inc.
Alzheimer Disease, Dementia, Alzheimer Type
Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's Disease
This is a Phase 2 study to evaluate safety and efficacy in participants with Mild Cognitive Impairment due to Alzheimer's Disease/Prodromal Alzheimer's Disease (referred to as MCI/Prodromal) and mild to moderate dementia due to…
- Trial name
- NCT02322021
- Testing
- E2609
- Where
- 21 sites in United States
- Volunteers
- 70 people
- Sponsor
- Eisai Inc.
Carcinoma, Hepatocellular
A Post-marketing Observational Study on Risk Factors for Hepatic Encephalopathy in Participants With Unresectable Hepatocellular Carcinoma
This study is a post-marketing observational study of lenvatinib in participants with unresectable hepatocellular carcinoma. The primary objective of this study is assessment of risk factors for hepatic encephalopathy.
- Trial name
- NCT03663114
- Testing
- Lenvatinib
- Where
- 2 sites in Japan
- Volunteers
- 713 people
- Sponsor
- Eisai Inc.
Postoperative Nausea and Vomiting
Pilot Study to Assess Palonosetron Versus Ondansetron as Rescue Medication in Subjects That Develop Postoperative Nausea and Vomiting (PONV) in the Postanesthesia Care Unit (PACU)
The purpose of this study is to investigate palonosetron versus ondansetron as rescue medication in subjects that develop postoperative nausea and vomiting (PONV) in the Postanaesthesia Care Unit (PACU).
- Trial name
- NCT00967499
- Testing
- Ondansetron, Palonosetron
- Where
- 8 sites in United States
- Volunteers
- 239 people
- Sponsor
- Eisai Inc.
Patients With Confirmed Malignant Disease to Receive Low Emetogenic Chemotherapy (LEC) or Who Experienced at Least Nausea and Vomiting During Last Cycle of LEC
A Study of Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Participants Who Have Experienced CINV(Chemotherapy-Induced Nausea and Vomiting) During the Previous Cycle of Low Emetogenic Chemotherapy (LEC)
This study is designed to assess the safety and efficacy of palonesetron in preventing chemotherapy-induced nausea and vomiting (CINV) when administered to participants who have experienced either vomiting and or at least…
- Trial name
- NCT01054456
- Testing
- palonesetron
- Where
- 9 sites in United States
- Volunteers
- 36 people
- Sponsor
- Eisai Inc.
Urinary Bladder Neoplasms
A Study of Stimulator of Interferon Genes (STING) Agonist E7766 in Non-muscle Invasive Bladder Cancer (NMIBC) Including Participants Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy, INPUT-102
This is an open label, multicenter, phase 1/1b study to assess safety/tolerability and preliminary clinical activity of E7766 as a single agent administered intravesically in participants with NMIBC.
- Trial name
- NCT04109092
- Testing
- E7766
- Where
- 9 sites in United States
- Sponsor
- Eisai Inc.
Alzheimer's Disease
A Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study
The purpose of this study will be to evaluate the safety and tolerability of lecanemab at sequentially ascending doses in subjects with mild to moderate Alzheimer's disease (AD).
- Trial name
- NCT01230853
- Testing
- Active Comparator: A, Active Comparator B
- Where
- 8 sites in United States
- Volunteers
- 80 people
- Sponsor
- Eisai Inc.
Irregular Sleep Wake Rhythm Disorder
A Study to Determine the Signs and Symptoms That Impact Daily Life of Participants With Irregular Sleep-Wake Rhythm Disorder
The primary purpose of this study is to determine the signs and symptoms of irregular sleep-wake rhythm disorder (ISWRD) that are important to patients and caregivers of patients with Alzheimer's disease dementia (AD-D), AD-D…
- Trial name
- NCT04300569
- Testing
- Non-interventional
- Where
- 6 sites in United States
- Volunteers
- 37 people
- Sponsor
- Eisai Inc.
Photosensitive Epilepsy
A Study to Evaluate the Pharmacodynamic Activity of E2082 in Adult Participants With Photosensitive Epilepsy
The primary purpose of the study is to assess pharmacodynamic (PD) activity of E2082 as measured by suppression of epileptic photoparoxysmal response (PPR) in the participant's most sensitive eye condition in participants with…
- Trial name
- NCT03686033
- Testing
- E2082
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- Eisai Inc.
Metastatic Breast Cancer
Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC)
The primary objective for the study is as follows: For the Phase 1b - to determine safety tolerability and recommended Phase 2 dose (RP2D) of eribulin mesylate in combination with PEGylated recombinant human hyaluronidase…
- Trial name
- NCT02753595
- Testing
- Eribulin mesylate, Biologic: PEGylated recombinant human hyaluronidase (PEGPH20), Biologic: PEGylated recombinant human hyaluronidase
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- Eisai Inc.
Insomnia Disorders
A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users
The primary purpose of this study is to evaluate the abuse potential of lemborexant (E2006) in comparison to placebo and 2 controls with known abuse potential (ie, zolpidem and suvorexant) with similar indications (zolpidem and…
- Trial name
- NCT03158025
- Testing
- Zolpidem tablets, Suvorexant tablets, over-encapsulated, Lemborexant tablets
- Where
- Canada
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Metastatic Breast Cancer
E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes
The purpose of this study is to compare E7389 versus capecitabine in patients with locally advanced or metastatic breast cancer who are refractory to the most recent chemotherapy.
- Trial name
- NCT00337103
- Testing
- Eribulin Mesylate, Capecitabine
- Where
- 169 sites in United States, Argentina and 21 more
- Volunteers
- 1,276 people
- Sponsor
- Eisai Inc.