Clinical trials: sponsored by Eisai Inc.
Pediatric Acute Myelogenous Leukemia (AML)
Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects
The purpose of this study is to provide data on the activity of a standard daunorubicin, cytarabine, and etoposide (ADE) induction plus epigenetic priming with decitabine as assessed by standard measures of complete remission…
- Trial name
- NCT01177540
- Testing
- Decitabine
- Where
- 22 sites in United States, Australia and 1 more
- Volunteers
- 25 people
- Sponsor
- Eisai Inc.
Partial Onset Seizures, Secondarily Generalized Seizures
Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures
This study will assess the retention rate of perampanel when given as monotherapy or first adjunctive therapy in participants with partial-onset seizures or primary generalized tonic clonic seizures.
- Conditions
- Partial Onset Seizures, Secondarily Generalized Seizures, Primary Generalized Tonic-Clonic Seizures
- Trial name
- NCT03288129
- Testing
- Perampanel
- Where
- 24 sites in United States
- Volunteers
- 54 people
- Sponsor
- Eisai Inc.
Breast Neoplasm
Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Combination With Pembrolizumab in Participants With Metastatic Triple-Negative Breast Cancer (mTNBC)
This is an open-label, single-arm, multicenter, Phase 1b/2 study of eribulin mesylate in combination with pembrolizumab in participants with mTNBC previously treated with 0 (stratum 1) or 1 to 2 (stratum 2) lines of systemic…
- Trial name
- ENHANCE-1 (NCT02513472)
- Testing
- Eribulin Mesylate, Pembrolizumab
- Where
- 22 sites in United States
- Volunteers
- 258 people
- Sponsor
- Eisai Inc.
Photosensitive Epilepsy
A Study to Evaluate the Pharmacodynamic Activity of E2730 in Adult Participants With Photosensitive Epilepsy
The primary purpose of the study is to assess the pharmacodynamic (PD) activity of E2730 as measured by suppression of epileptic photoparoxysmal response (PPR) in the participant's most sensitive eye condition in participants…
- Trial name
- NCT03603639
- Testing
- E2730
- Where
- 5 sites in United States
- Volunteers
- 6 people
- Sponsor
- Eisai Inc.
Gastroesophageal Reflux Disease (GERD)
Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
The purpose of this study is to compare the efficacy of rabeprazole extended release (ER) 50 mg (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing in subjects with healed erosive…
- Trial name
- NCT00838526
- Testing
- Rabeprazole ER, Ranitidine
- Where
- 4 sites in United States
- Volunteers
- 240 people
- Sponsor
- Eisai Inc.
Stage IIIC Melanoma, Stage IV Melanoma
Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma
The purpose of this study is to determine whether participants with Stage IIIC and Stage IV Melanoma experience benefit when treated with Denileukin diftitox in two different dosing schedules.
- Trial name
- NCT01127451
- Testing
- Denileukin diftitox
- Where
- 10 sites in United States
- Volunteers
- 75 people
- Sponsor
- Eisai Inc.
Lennox-Gastaut Syndrome (LGS)
Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome
This study is being conducted to demonstrate that perampanel given as adjunctive anti-epileptic treatment is superior to placebo in reducing the number of drop seizures in participants with inadequately controlled seizures…
- Trial name
- NCT02834793
- Testing
- Perampanel
- Where
- 65 sites in United States, Australia and 5 more
- Volunteers
- 101 people
- Sponsor
- Eisai Inc.
Bladder Cancer
Eribulin Mesylate Administered in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladder Cancer
The purpose of this study is to determine whether Patients with Locally Advanced or Metastatic Bladder Cancer who receive Eribulin Mesylate Administered in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus…
- Trial name
- NCT01126749
- Testing
- Gemcitabine, E7389, Cisplatin
- Where
- 42 sites in United States, Germany and 4 more
- Volunteers
- 92 people
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study of Subcutaneous Lecanemab in Healthy Participants
The primary purpose of this study is to determine the absolute bioavailability and pharmacokinetic (PK) profile of a single dose of lecanemab when administered subcutaneously (SC) in healthy participants.
- Trial name
- NCT05045716
- Testing
- Lecanemab
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Attention Impairment
Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children With Attention Impairment Following Cancer Treatment
The purpose of this study is to evaluate the efficacy, safety and tolerability of donepezil in children with persistent attention impairment that is present at least 12 months after the completion of cancer treatment.
- Trial name
- NCT00688376
- Testing
- Donepezil hydrochloride
- Where
- 31 sites in United States, Argentina and 8 more
- Volunteers
- 72 people
- Sponsor
- Eisai Inc.
Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck
E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck
The purpose of this study is to determine whether participants with platinum-resistant squamous cell carcinoma of the head and neck (SCCHN) who receive either E7050 administered with cetuximab or cetuximab alone experience…
- Trial name
- NCT01332266
- Testing
- E7050, Cetuximab
- Where
- 23 sites in United States, South Korea and 2 more
- Volunteers
- 95 people
- Sponsor
- Eisai Inc.
Liver Cancer
Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum tolerated dose (MTD) and to investigate the efficacy, safety and pharmacokinetics of irofulven combined with oxaliplatin in patients with advanced solid tumors.
- Trial name
- NCT00374660
- Testing
- Oxaliplatin, Irofulven
- Where
- 7 sites in France
- Volunteers
- 63 people
- Sponsor
- Eisai Inc.
Thyroid Cancer
A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile
This is a multicenter, randomized, double-blind study being conducted as a postmarketing requirement to the US Food and Drug Administration (FDA) to evaluate whether there is a lower starting dosage of lenvatinib 24 mg once daily…
- Trial name
- NCT02702388
- Testing
- Lenvatinib
- Where
- 101 sites in United States, Australia and 14 more
- Volunteers
- 241 people
- Sponsor
- Eisai Inc.
Alzheimer's Disease
Open-Label Extension Study of 23 mg Donepezil SR in Participants With Moderate to Severe Alzheimer's Disease
The purpose of this study is to evaluate the safety and efficacy of long-term administration of 23 milligram (mg) donepezil sustained release (SR) in participants with moderate to severe Alzheimer's disease.
- Trial name
- NCT00566501
- Testing
- Donepezil
- Where
- United States
- Volunteers
- 915 people
- Sponsor
- Eisai Inc.
Alzheimer's Disease
Neural Correlates In Mild Alzheimer's Disease
The objective of this study was to identify neural correlates of cognitive improvement after 3 months of donepezil hydrochloride treatment using either or both of two functional magnetic resonance imaging (fMRI) measures - the…
- Trial name
- NCT00477659
- Testing
- Donepezil hydrochloride
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study to Evaluate Lemborexant in Milk of Healthy Lactating Women
The primary purpose of the study is to estimate the cumulative amount of lemborexant excreted in breast milk following a single dose administration of lemborexant 10 milligram (mg) to healthy lactating women and to estimate the…
- Trial name
- NCT04890561
- Testing
- Lemborexant
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Platinum-Sensitive Ovarian Cancer in First Relapse
A Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Participants With Low CA125 Platinum-sensitive Ovarian Cancer
MORAb-003-011 is a global, multicenter, double-blind, randomized placebo-controlled study to assess the safety and efficacy of farletuzumab in combination with standard chemotherapy in subjects with low cancer antigen 125 (CA125)…
- Trial name
- NCT02289950
- Testing
- Farletuzumab
- Where
- 68 sites in United States, Belgium and 5 more
- Volunteers
- 332 people
- Sponsor
- Eisai Inc.
Metastatic Melanoma
Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma
This is a global, Phase 2, open label, dose selection, proof-of-concept study to assess progression free survival in subjects with metastatic melanoma.
- Trial name
- NCT01335009
- Testing
- MORAb-004 (monoclonal antibody)
- Where
- 29 sites in United States, Australia and 2 more
- Volunteers
- 76 people
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study to Assess the Safety and Tolerability of E2730 After Multiple Dose and the Food Effect After Single Dose in Healthy Participants
The primary purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of E2730 of multiple ascending oral doses in healthy adult participants and to assess the differences in PK, safety, and…
- Trial name
- NCT04676685
- Testing
- E2730
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Obesity
Study to Evaluate the Efficacy and Safety of Belviq XR® in Conjunction With Lifestyle Modification for Weight Loss in Obese Adolescents, Age 12 to 17 Years
This study will be conducted to demonstrate weight loss efficacy by change in body mass index (BMI) and safety in adolescents age 12 to 17 years (inclusive) during 52 weeks of treatment with Belviq XR 20 milligrams (mg)…
- Trial name
- NCT03338296
- Testing
- lorcaserin hydrochloride XR
- Where
- 16 sites in United States
- Volunteers
- 278 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.