Clinical trials: sponsored by Eisai Inc.
Alzheimer's Disease
A Retrospective Database Study for the Development and Validation of Algorithms for Intracerebral Hemorrhage and Seizures in Alzheimer's Disease
The primary objective of this study is to develop and validate claims-based algorithms to identify intracerebral hemorrhage >1 cm in diameter, ensuring differentiation from amyloid-related imaging abnormality-microhemorrhage and…
- Trial name
- NCT07723950
- Testing
- No intervention
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- Eisai Inc.
Epilepsies, Myoclonic, Drug Resistant Epilepsy
Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies
The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies.
- Trial name
- NCT04457687
- Testing
- Lorcaserin
- Where
- 22 sites in United States, Canada
- Sponsor
- Eisai Inc.
Endometrial Neoplasms, Neoplasms
A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor
The primary objective of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s), and to determine the optimal dose of E7386…
- Conditions
- Endometrial Neoplasms, Neoplasms, Carcinoma, Hepatocellular, Liver Neoplasms
- Trial name
- NCT04008797
- Testing
- E7386, Lenvatinib, Doxorubicin
- Where
- 106 sites in United States, Canada and 8 more
- Volunteers
- 301 people
- Sponsor
- Eisai Inc.
Alzheimers Disease
A Postmarketing Study of LEQEMBI in Participants With Alzheimer's Disease
The primary purpose of this study is to evaluate the efficacy of LEQEMBI in participants with early Alzheimer's disease (AD) indicated per Canada Product Monograph (APOE4 non-carriers and heterozygotes; indicated population)…
- Trial name
- NCT07864623
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 270 people
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy Participants
The primary purpose of this study is to assess potential drug-drug interactions of E2086 when coadministered orally with Itraconazole, Carbamazepine, Midazolam, Dextromethorphan, Bupropion, or Combined Oral Contraceptives in…
- Trial name
- NCT07766369
- Testing
- E2086
- Where
- United States
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Early Alzheimer's Disease
A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease
This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical…
- Trial name
- Clarity AD (NCT03887455)
- Testing
- Lecanemab IV, Lecanemab SC
- Where
- 247 sites in United States, Australia and 12 more
- Volunteers
- 1,906 people
- Sponsor
- Eisai Inc.
Carcinoma, Hepatocellular
Real-World Lenvatinib Sequencing in Unresectable Hepatocellular Carcinoma (uHCC)
This observational study will use existing real-world data from routine clinical care to describe patients with uHCC who received lenvatinib.
- Trial name
- NCT07849660
- Testing
- Lenvatinib
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Eisai Inc.
Alzheimer's Disease
A Postmarketing Study of Lecanemab for the Treatment of Participants With Alzheimer's Disease
The primary purpose of this study is to evaluate the safety of lecanemab-irmb in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition…
- Trial name
- NCT07821658
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 6,700 people
- Sponsor
- Eisai Inc.
Receptors, Estrogen, Genes, Erbb-2
A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer
The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2…
- Conditions
- Receptors, Estrogen, Genes, Erbb-2, Breast Neoplasms
- Trial name
- NCT04288089
- Testing
- Palbociclib (75, 100, 125 milligram [mg]), H3B-6545 (150, 300, 450 mg)
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 31 people
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants
The primary purpose of this study is to determine the metabolism and excretion of [14C]E2086 in healthy male participants.
- Trial name
- NCT07308236
- Testing
- E2086
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Alzheimers Disease
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2511 in Participants With Early Alzheimer's Disease (AD)
The primary purpose of this study is to evaluate proof of mechanism (POM) and long-term safety and tolerability of E2511 in participants with Early AD. The study consists of 2 parts.
- Trial name
- NCT07768592
- Testing
- E2511, Donepezil
- Volunteers
- 32 people
- Sponsor
- Eisai Inc.
Malaria, Healthy Participants
A Study of Oral E1018 in Healthy Adult Participants
The primary purpose of the study is to evaluate the safety and tolerability of single ascending oral doses of E1018 in healthy adult participants and to evaluate the pharmacokinetics (PK) of E1018 in plasma and urine after single…
- Trial name
- NCT06854042
- Testing
- E1018
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Pediatric Epileptic Syndrome, Partial-onset Seizures
A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy
The purpose of the study is to evaluate the efficacy of perampanel as measured by the 50 percent (%) responder rate during the maintenance period of the core study for seizure frequency in participants with pediatric epileptic…
- Trial name
- NCT04015141
- Testing
- Perampanel Oral Suspension, Perampanel Tablet
- Where
- 35 sites in United States, Belgium and 4 more
- Volunteers
- 100 people
- Sponsor
- Eisai Inc.
Lennox Gastaut Syndrome
An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303
This is an extended access study for participants who have completed Rufinamide Study E2080-G000-303 to continue to have access to rufinamide until it becomes commercially available in Poland or until no participants remain in…
- Trial name
- NCT03778424
- Testing
- Rufinamide
- Where
- 2 sites in Poland
- Sponsor
- Eisai Inc.
Advanced Neoplasms
Study of E7386 in Participants With Selected Advanced Neoplasms
This study will be conducted to assess the safety/tolerability profile of E7386 as a single agent administered orally in participants with selected advanced or recurrent neoplasms and to determine the maximum tolerated dose (MTD)…
- Trial name
- NCT03264664
- Testing
- E7386
- Where
- 10 sites in United States, United Kingdom
- Volunteers
- 60 people
- Sponsor
- Eisai Inc.
Preclinical Alzheimer's Disease, Early Preclinical Alzheimer's Disease
AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid
The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial)…
- Trial name
- NCT04468659
- Testing
- Lecanemab
- Where
- 107 sites in United States, Australia and 5 more
- Volunteers
- 1,400 people
- Sponsor
- Eisai Inc.
Solid Tumor
A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types
The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with…
- Trial name
- NCT04300556
- Testing
- Farletuzumab ecteribulin, Prednisone, Prednisolone
- Where
- 58 sites in United States, France and 3 more
- Volunteers
- 182 people
- Sponsor
- Eisai Inc.
Breast Cancer
A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer
The primary purpose of the Dose Optimization (Part 1) of this study is to assess the safety and tolerability of BB-1701 and to determine the recommended dose (RD) of BB-1701 for Dose Expansion (Part 2).
- Trial name
- NCT06188559
- Testing
- BB-1701
- Where
- 49 sites in United States, France and 2 more
- Volunteers
- 56 people
- Sponsor
- Eisai Inc.
Narcolepsy
A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy
The primary purpose of this study is to evaluate the optimal doses of E2086 compared to placebo in participants with narcolepsy for reduction of excessive daytime sleepiness (EDS) as assessed by Mean Sleep Latency (MSL) (measured…
- Trial name
- NCT07493265
- Testing
- E2086
- Where
- 57 sites in United States, Belgium and 8 more
- Volunteers
- 64 people
- Sponsor
- Eisai Inc.
Endometrial Neoplasms
Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])
This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer.
- Trial name
- NCT03517449
- Testing
- Pembrolizumab, Lenvatinib, Paclitaxel
- Where
- 169 sites in United States, Argentina and 19 more
- Volunteers
- 827 people
- Sponsor
- Eisai Inc.