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.
Refractory or Recurrent Solid Tumors, Rhabdomyosarcoma
Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Children With Refractory or Recurrent Solid Tumors
The Phase 1 part of the study is conducted to determine the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D) of eribulin mesilate in combination with irinotecan hydrochloride in pediatric participants with…
- Conditions
- Refractory or Recurrent Solid Tumors, Rhabdomyosarcoma, Non-Rhabdomyosarcoma Soft Tissue Sarcoma, Ewing Sarcoma
- Trial name
- NCT03245450
- Testing
- Eribulin mesilate, Irinotecan hydrochloride
- Where
- 39 sites in France, Germany and 6 more
- Volunteers
- 40 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.
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.
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.
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.
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.
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.