Clinical trials: sponsored by Eisai Inc.
Alzheimer's Disease
A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease
This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group study using a Bayesian design with response adaptive randomization across placebo or 5 active arms of lecanemab to determine clinical efficacy…
- Trial name
- NCT01767311
- Testing
- Lecanemab 2.5 mg/kg, Lecanemab 5.0 mg/kg, Lecanemab 10 mg/kg
- Where
- 169 sites in United States, Canada and 9 more
- Volunteers
- 856 people
- Sponsor
- Eisai Inc.
Renal Cell Carcinoma
Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by…
- Trial name
- CLEAR (NCT02811861)
- Testing
- Lenvatinib, Everolimus, Pembrolizumab
- Where
- 183 sites in United States, Australia and 18 more
- Volunteers
- 1,069 people
- Sponsor
- Eisai Inc.
Alzheimer's Disease
A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease
The primary objective of the study is to determine the dose response of E2814, when concurrently administered with lecanemab, on the change from baseline at 6 months in cerebrospinal fluid (CSF) microtubule-binding region…
- Trial name
- NCT06602258
- Testing
- E2814, Lecanemab
- Where
- 26 sites in United States, Japan
- Volunteers
- 105 people
- Sponsor
- Eisai Inc.
Melanoma, Carcinoma, Hepatocellular
A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors
The Phase 1b part of this study is conducted to assess the safety and tolerability of E7386 in combination with pembrolizumab in participants with previously treated selected solid tumors, and to determine the recommended Phase 2…
- Conditions
- Melanoma, Carcinoma, Hepatocellular, Colorectal Neoplasms
- Trial name
- NCT05091346
- Testing
- E7386, Pembrolizumab, Lenvatinib
- Where
- 32 sites in United States, Japan and 2 more
- Volunteers
- 89 people
- Sponsor
- Eisai Inc.
Epilepsies, Myoclonic
A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
The primary purpose of the study is to demonstrate that lorcaserin has superior efficacy compared to placebo on percent change in frequency of convulsive seizures per 28 days in participants with Dravet syndrome.
- Trial name
- MOMENTUM 1 (NCT04572243)
- Testing
- Lorcaserin
- Where
- 30 sites in United States, Canada
- Volunteers
- 22 people
- Sponsor
- Eisai Inc.
Primary Generalized Tonic-Clonic or Partial Onset Seizures, Lennox Gastaut Syndrome
An Extended Access Program (EAP) for Perampanel
The main objective of this EAP is to ensure that participants participating in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338 or EAP E2007-G000-401 continue to have access to perampanel until such time…
- Trial name
- NCT02307578
- Testing
- Perampanel
- Where
- 27 sites in Belgium, Chile and 8 more
- Sponsor
- Eisai Inc.
Sleep Initiation and Maintenance Disorders, Pregnancy
A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population
The primary purpose of the study is to compare the occurrence of major congenital malformations (MCMs) among live births between women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy and women with…
- Trial name
- NCT06744673
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 861 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Alzheimer Disease
A Study to Assess Safety and Target Engagement of E2814 in Participants With Mild to Moderate Cognitive Impairment Due to Dominantly Inherited Alzheimer's Disease
The primary objective of the study is to assess the safety and tolerability of intravenous (IV) infusions of E2814 in participants with dominantly inherited Alzheimer's disease (DIAD), and to evaluate target engagement (TE) of…
- Trial name
- NCT04971733
- Testing
- E2814
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 8 people
- Sponsor
- Eisai Inc.
Narcolepsy Type 1 (NT1)
A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1
The primary purpose of this study is to evaluate the efficacy of single oral doses of E2086 compared to placebo in the treatment of excessive daytime sleepiness (EDS) as assessed by the Maintenance of Wakefulness Test (MWT) in…
- Trial name
- NCT06462404
- Testing
- E2086, Active Comparator
- Where
- 14 sites in United States, Canada
- Volunteers
- 22 people
- Sponsor
- Eisai Inc.
Renal Cell Carcinoma
Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma
Study E7080-G000-218 is a Randomized, open-label (formerly Double-blind), Phase 2 Trial conducted to assess whether a starting dose of lenvatinib 14 milligrams (mg) in combination with everolimus 5 mg once daily (QD) will provide…
- Trial name
- NCT03173560
- Testing
- lenvatinib, everolimus
- Where
- 93 sites in United States, Australia and 14 more
- Volunteers
- 343 people
- Sponsor
- Eisai Inc.
Breast Neoplasms, Breast Cancer
Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive…
- Conditions
- Breast Neoplasms, Breast Cancer, Estrogen-receptor Positive Breast Cancer, Cancer, Breast
- Trial name
- NCT03250676
- Testing
- H3B-6545
- Where
- 39 sites in United States, France and 1 more
- Volunteers
- 151 people
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study of E2086 in Healthy Adult Participants
The primary purpose of the study is to evaluate the safety and tolerability following multiple ascending doses of E2086 in healthy adult participants.
- Trial name
- NCT06481488
- Testing
- E2086
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Solid Tumors
Study to Assess the Long-term Safety of Lenvatinib Monotherapy, a Lenvatinib Combination Regimen, or a Comparator Treatment Arm to Cancer Participants in Eisai Sponsored Lenvatinib Trials
This study will be conducted to assess the long-term safety of study drug(s) in participants who are enrolled in Eisai-sponsored lenvatinib studies.
- Trial name
- NCT03477175
- Testing
- E7080, Comparator Drug, Comparator Drug: Sorafenib
- Where
- 28 sites in United States, Australia and 9 more
- Volunteers
- 40 people
- Sponsor
- Eisai Inc.
Persistent or Recurrent Cutaneous T-Cell Lymphoma
A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma
The purpose of this trial is to assess the efficacy of E7777 in participants with recurrent or persistent Cutaneous T-Cell Lymphoma (CTCL) in Stage I - III participants as assessed by objective response rate (ORR).
- Trial name
- NCT01871727
- Testing
- E7777 9 mcg/kg
- Where
- 22 sites in United States, Australia and 1 more
- Volunteers
- 112 people
- Sponsor
- Eisai Inc.
Insomnia
Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2…
- Trial name
- SUNRISE 1 (NCT02783729)
- Testing
- Lemborexant, Zolpidem tartrate
- Where
- 102 sites in United States, Canada and 5 more
- Volunteers
- 1,006 people
- Sponsor
- Eisai Inc.
Solid Tumors
Study of Poly (ADP-Ribose) Polymerase (PARP) Inhibitor E7016 in Combination With Temozolomide in Subjects With Advanced Solid Tumors
The purpose of this study is to determine the maximum tolerated dose (MTD) of poly (ADP-Ribose) polymerase inhibitor E7016 when used with temozolomide (TMZ) in patients with advanced solid tumors and gliomas.
- Trial name
- NCT01127178
- Testing
- E7016 + TMZ
- Where
- 5 sites in United States
- Volunteers
- 12 people
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2086 in Healthy Adult and Elderly Participants
The primary objective of this study is to evaluate the safety and tolerability of E2086 following administration of a single oral doses in healthy adult and elderly participants.
- Trial name
- NCT05745207
- Testing
- E2086
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Osteosarcoma
A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma
This Is a Multicenter, Randomized, Open-Label, Parallel-Group, Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents…
- Trial name
- NCT04154189
- Testing
- Lenvatinib, Ifosfamide, Etoposide
- Where
- 84 sites in United States, Australia and 19 more
- Volunteers
- 81 people
- Sponsor
- Eisai Inc.
Carcinoma, Hepatocellular
A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma
The primary purpose of this study is to further characterise the hepatotoxicity in participants with advanced or unresectable hepatocellular carcinoma (HCC) treated with lenvatinib, and to further characterise the overall safety…
- Trial name
- STELLAR (NCT04763408)
- Testing
- Lenvatinib, Sorafenib
- Where
- 44 sites in United States, Australia and 8 more
- Volunteers
- 335 people
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of E2025 in Healthy Participants
The primary purpose of the study is to evaluate the safety and tolerability of single intravenous (IV) infusions of E2025 in healthy adult participants.
- Trial name
- NCT05726851
- Testing
- E2025
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.