Clinical trials: sponsored by Eisai Inc.
Vertigo
A Study To Evaluate The Efficacy And Safety Of Betahistine Mesilate In The Treatment Of Patients With Vertigo Caused By Cerebral Infarction In Posterior Circulation
The purpose of this study is to determine the efficacy and safety of Betahistine Mesilate in the treatment of patients with vertigo caused by Cerebral Infarction in posterior circulation.
- Trial name
- NCT00474409
- Testing
- Merislon
- Where
- 4 sites in China
- Sponsor
- Eisai Inc.
Advanced or Metastatic Solid Tumors, Previously Untreated Gastric Cancer
E7050 in Combination With Cisplatin and Capecitabine Versus Cisplatin and Capecitabine Alone in Patients With Advanced or Metastatic Solid Tumors and Previously Untreated Gastric Cancer
The purpose of this study is to determine the following: 1. Find the maximum tolerated dose of E7050 when given in combination with cisplatin and capecitabine in patients with advance or metastatic solid tumors, and 2) Whether…
- Trial name
- NCT01355302
- Testing
- E7050, cisplatin, capecitabine
- Where
- 19 sites in United States, Russia and 2 more
- Volunteers
- 7 people
- Sponsor
- Eisai Inc.
Soft Tissue Sarcoma
E7389 Administered as an IV Bolus Infusion Day 1 and Day 8 Every 3 Weeks in Pre-Treated Patients With Advanced and/or Metastatic Soft Tissue Sarcoma
The purpose of this study is to evaluate the therapeutic activity and safety of E7389 in patients with advanced/metastatic soft tissue sarcoma who have failed standard chemotherapy.
- Trial name
- NCT00413192
- Testing
- E7389
- Where
- 15 sites in Belgium, Denmark and 3 more
- Volunteers
- 128 people
- Sponsor
- Eisai Inc.
Healthy Participants
Study to Assess Pharmacokinetic Drug-Drug Interaction Between Avatrombopag When Co-Administered With Fluconazole, Itraconazole, or Rifampin in Healthy Subjects
The purpose of this study is to determine the effects of concomitant administration with fluconazole, itraconazole, and rifampin on the pharmacokinetics (PK) of a single 20-mg dose of avatrombopag in healthy participants.
- Trial name
- NCT02809768
- Testing
- Avatrombopag, Fluconazole, Itraconazole
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Epilepsy, Partial-Onset Seizures
Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Patients With Epilepsy
The primary objective of this study is to assess the retention rate of perampanel when given as secondary monotherapy in routine clinical care.
- Conditions
- Epilepsy, Partial-Onset Seizures, Primary Generalized Tonic-Clonic Seizures
- Trial name
- NCT02736162
- Testing
- No treatment (intervention) was administered
- Volunteers
- 61 people
- Sponsor
- Eisai Inc.
Healthy Participants
Study to Assess the Safety, Tolerability, Pharmacokinetics of E2027 in Healthy Adult and Elderly Subjects, and the Pharmacodynamics in Healthy Adult Subjects
This first-in-human study, designed to assess the safety, tolerability, and pharmacokinetics (PK) of single oral ascending doses of E2027, will be administered to healthy adult participants to determine the maximum tolerated dose…
- Trial name
- NCT02415790
- Testing
- E2027
- Where
- United States
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Chronic Plaque Psoriasis
Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis
This is a double-blind, multicenter study to assess the efficacy and safety of E6201 topical administration to pre-identified marker lesions in adult subjects with chronic plaque type psoriasis.
- Trial name
- NCT00539929
- Testing
- E6201 0.005%, E6201 0.01%, E6201 0.03%
- Where
- 12 sites in United States
- Volunteers
- 100 people
- Sponsor
- Eisai Inc.
Anesthesia
A PK/PD Study of Fospropofol Disodium Compared With Propofol Injectable Emulsion
This study is designed to characterize the pharmacokinetic and pharmacodynamic effect of fospropofol disodium in comparison to propofol.
- Trial name
- NCT01260142
- Testing
- Fospropofol disodium, propofol
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Alzheimer's Disease
Evaluation of E2609 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (Study: E2609-A001-101 Amendment 02)
Subjects will be adults aged 50 to 85 years who have subjective memory complaints and mild cognitive impairment or mild dementia due to Alzheimer's disease (AD).
- Trial name
- NCT01600859
- Testing
- E2609
- Where
- 2 sites in United States
- Volunteers
- 65 people
- Sponsor
- Eisai Inc.
Coronary Artery Disease
Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease
The primary purpose of this study is to assess the safety and tolerability of E5555 in subjects with coronary artery disease.
- Trial name
- NCT00312052
- Testing
- E5555
- Where
- 2 sites in United States
- Volunteers
- 720 people
- Sponsor
- Eisai Inc.
Multiple Myeloma
Safety and Efficacy Study for the Prevention of Nausea and Vomiting in Multiple Myeloma Patients Receiving Stem Cell Transplantation.
The primary purpose of this study is to explore the efficacy of three different dose schedules of palonosetron for the prevention of emesis over a 7-day study interval in multiple myeloma patients.
- Trial name
- NCT00306735
- Testing
- Palonosetron
- Where
- 10 sites in United States
- Volunteers
- 75 people
- Sponsor
- Eisai Inc.
Stage IV Melanoma
E7080 (Lenvatinib) in Combination With Dacarbazine Versus Dacarbazine Alone as First Line Therapy in Patients With Stage IV Melanoma
Primary: Phase Ib: To define the safety, tolerability and maximum tolerated dose (MTD) of lenvatinib administered in combination with dacarbazine.
- Trial name
- NCT01133977
- Testing
- Lenvatinib, Dacarbazine
- Where
- 27 sites in United States, Germany and 3 more
- Volunteers
- 97 people
- Sponsor
- Eisai Inc.
Cancer: Solid Tumors
An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors
The purpose of this study is to determine the maximum tolerable dose (MTD) and the related effects of E7080 administered to patients with solid tumors that are resistant to approved existing anti-tumor therapies, or for which no…
- Trial name
- NCT00280397
- Testing
- E7080
- Where
- Japan
- Volunteers
- 27 people
- Sponsor
- Eisai Inc.
Wild Type BRAF Stage IV Melanoma, Unresectable Stage III Melanoma
Phase 2 Study of the Poly(ADP-Ribose) Polymerase Inhibitor E7016 in Combination With Temozolomide in Subjects With Wild Type BRAF Stage IV or Unresectable Stage III Melanoma
This is a Phase 2, open-label, multicenter study to assess the PFS-6m of E7016 at the selected dose of 320-mg once daily (QD) in combination with 150-mg/m2 of Temozolomide (TMZ) in subjects with wt BRAF Stage IV or unresectable…
- Trial name
- NCT01605162
- Testing
- TMZ, E7016
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Eisai Inc.
Central Nervous System
Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs
This study is designed to evaluate the pharmacokinetics, efficacy, and safety of perampanel oral suspension on seizure frequency in pediatric participants maintained on one to three stable antiepileptic drugs
- Trial name
- NCT01527006
- Testing
- perampanel
- Where
- 23 sites in United States
- Volunteers
- 63 people
- Sponsor
- Eisai Inc.
Unspecified Adult Solid Tumor, Protocol Specific
An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function
This is an open-label non-randomized study in subjects with advanced or metastatic solid tumors who are no longer responding to available therapy. HALAVEN will be administered to subjects on Days 1 and 8 of a 21-day cycle.
- Trial name
- NCT01418677
- Testing
- E7389
- Where
- 9 sites in United States
- Volunteers
- 19 people
- Sponsor
- Eisai Inc.
Gastroesophageal Reflux Disease (GERD)
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)
The purpose of this study is to investigate the efficacy and safety of Rabeprazole (RAB) Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg in subjects with erosive gastroesophageal reflux disease (eGERD).
- Trial name
- NCT00658632
- Testing
- Rabeprazole sodium, Esomeprazole
- Where
- 85 sites in United States
- Volunteers
- 1,397 people
- Sponsor
- Eisai Inc.
Differentiated Thyroid Cancer
An Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer
This Expanded Access Program (EAP) consists of a Prerandomization Phase and a Randomization Phase. Only subjects with radioiodine-refractory DTC who fulfill the eligibility criteria will be treated.
- Trial name
- NCT02211222
- Testing
- Lenvatinib
- Where
- 13 sites in United States
- Sponsor
- Eisai Inc.
Epilepsy
Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of…
- Trial name
- NCT00735397
- Testing
- perampanel
- Where
- 239 sites in United States, Argentina and 37 more
- Volunteers
- 1,218 people
- Sponsor
- Eisai Inc.
Gastroesophageal Reflux Disease (GERD)
Rabeprazole Extended Release 50 mg Versus 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 50 mg (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing in subjects with healed erosive…
- Trial name
- NCT00839306
- Testing
- Rabeprazole ER, Ranitidine
- Where
- 4 sites in United States
- Volunteers
- 240 people
- Sponsor
- Eisai Inc.