Clinical trials: sponsored by Eisai Inc.
Thyroid Cancer
Evaluating the Safety and Efficacy of Oral Lenvatinib in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology
The purpose of this study is to determine the safety and efficacy of oral lenvatinib in participants with medullary thyroid cancer (MTC) or radioiodine (131 I)-refractory/resistant differentiated thyroid cancer (DTC)…
- Trial name
- NCT00784303
- Testing
- Lenvatinib (DTC Cohort), Lenvatinib (MTC Cohort)
- Where
- 42 sites in United States, Australia and 4 more
- Volunteers
- 117 people
- Sponsor
- Eisai Inc.
Partial Onset Seizures
An Extended Access Program for Perampanel
The Extended Access Program (EAP) is a managed access programme for Perampanel. The main objective of this EAP is to ensure that patients participating in studies E2007-A001-207, E2007-G000-307, or E2007-G000-235 continue to have…
- Trial name
- NCT01871233
- Testing
- Perampanel
- Where
- 78 sites in Argentina, Australia and 19 more
- Sponsor
- Eisai Inc.
Hepatic Impairment
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects
This study will be conducted to assess the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of lemborexant after a single-dose administration.
- Trial name
- NCT03440424
- Testing
- Lemborexant
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Lymphoma, T-Cell, Peripheral
A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma
Study of ONTAK and CHOP (chemotherapy drugs) to find out their ability to make Peripheral T-cell lymphoma disappear (for any period of time) and potentially lengthen life.
- Trial name
- NCT00211185
- Testing
- Denileukin diftitox, Cyclophosphamide, Doxorubicin
- Where
- 49 sites in United States
- Volunteers
- 49 people
- Sponsor
- Eisai Inc.
Metastatic Brain Cancer
Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer
The purpose of this study is to determine the effect of the surgical intervention and insertion of GLIADEL wafers on the neurocognitive functioning in patients with metastatic brain cancer.
- Trial name
- NCT00525590
- Testing
- GLIADEL
- Where
- 17 sites in United States
- Volunteers
- 69 people
- Sponsor
- Eisai Inc.
Renal Impairment
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment
This study will be conducted to assess the effect of severe renal impairment on the pharmacokinetics of lemborexant after a single-dose administration.
- Trial name
- NCT03443063
- Testing
- Lemborexant
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Obstructive Sleep Apnea, Healthy Subjects
Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea
This study will be conducted to determine whether lemborexant as compared to placebo decreases the peripheral oxygen saturation during total sleep time in healthy adult and elderly participants after a single dose of treatment…
- Trial name
- NCT03471871
- Testing
- Lemborexant 10 mg, Lemborexant 25 mg
- Where
- 11 sites in United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Tumors
Study of E7046 in Subjects With Selected Advanced Malignancies
This is an open label, multicenter, Phase 1 study of E7046 to assess the safety and tolerability of E7046 and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of E7046.
- Trial name
- NCT02540291
- Testing
- E7046
- Where
- 3 sites in United States, France
- Volunteers
- 31 people
- Sponsor
- Eisai Inc.
Insomnia Disorder
Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)
The key objectives of this study are to determine, using sleep diaries, whether lemborexant at the doses 5 milligrams (mg) and 10 mg is superior to placebo on subjective sleep onset, subjective sleep efficiency, and subjective…
- Trial name
- NCT02952820
- Testing
- lemborexant
- Where
- 114 sites in United States, Canada and 10 more
- Volunteers
- 971 people
- Sponsor
- Eisai Inc.
Chronic Insomnia, Adults
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia
This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, parallel-group, Bayesian adaptive, dose response study in subjects with chronic insomnia.
- Conditions
- Chronic Insomnia, Adults, Elderly
- Trial name
- NCT01995838
- Testing
- E2006
- Where
- 29 sites in United States
- Volunteers
- 291 people
- Sponsor
- Eisai Inc.
Down Syndrome, Cognitive Dysfunction
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10
The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of cognitive dysfunction shown by children with Down syndrome, aged 6 to 10 years.
- Trial name
- NCT00754013
- Testing
- Aricept (Donepezil hydrochloride)
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Eisai Inc.
Insomnia Disorder
Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder
This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage strengths of lemborexant (5 mg and 10 mg) in participants with insomnia disorder.
- Trial name
- NCT02350309
- Testing
- Lemborexant 5 mg, Lemborexant 10 mg, Flurazepam 30 mg
- Where
- 2 sites in United States
- Volunteers
- 69 people
- Sponsor
- Eisai Inc.
Insomnia
A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006
Part A: The purpose of this study is to evaluate the safety and tolerability of single oral doses of E2006 administered in the morning to healthy male and female subjects.
- Trial name
- NCT01463098
- Testing
- E2006 1.0 mg, E2006 2.5 mg, E2006 5.0 mg
- Where
- 2 sites in United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Refractory Partial Seizures
Evaluating the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
The purpose of this study is to evaluate the safety, efficacy and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.
- Trial name
- NCT00699972
- Testing
- E2007 (perampanel)
- Where
- 97 sites in United States, Argentina and 4 more
- Volunteers
- 390 people
- Sponsor
- Eisai Inc.
Breast Cancer
E7389 Versus Treatment of Physician's Choice in Patients With Locally Recurrent or Metastatic Breast Cancer
The purpose of this study is to compare Overall Survival (OS), Progression Free Survival (PFS), objective tumor response rate, duration of response, and safety in patients treated with E7389 versus the Treatment of Physician's…
- Trial name
- NCT00388726
- Testing
- E7389, Physician's Choice
- Where
- 137 sites in United States, Argentina and 15 more
- Volunteers
- 762 people
- Sponsor
- Eisai Inc.
Carcinoma, Hepatocellular
Trial to Evaluate Safety and Efficacy of Treatment of Physician Choice (TPC) Following First-Line Treatment of Lenvatinib in Subjects With Unresectable Hepatocellular Carcinoma (uHCC)
The primary objective of this study is to assess the safety and tolerability of subsequent systemic treatment of physician's choice (TPC) following the first-line lenvatinib treatment in unresectable hepatocellular carcinoma…
- Trial name
- NCT03433703
- Testing
- Lenvatinib
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Eisai Inc.
Dementias With Lewy Bodies
A Study to Determine the Metabolism and Elimination of [14C]E2027 in Healthy Male Participants
The primary objective of the study is to achieve mass balance recovery of [14C]-radiolabel in urine and feces and to identify and quantify the main elimination pathways of E2027.
- Trial name
- NCT04023877
- Testing
- E2027
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Breast Neoplasms
A Study to Evaluate Safety, Tolerability and Efficacy of Eribulin Mesylate in Treating Adult Females With Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to evaluate clinical and laboratory safety of eribulin mesylate in treating participants with locally advanced or metastatic breast cancer, who have progressed after at least one regimen of…
- Trial name
- NCT03583944
- Testing
- Eribulin Mesylate
- Where
- 18 sites in India
- Volunteers
- 200 people
- Sponsor
- Eisai Inc.
Refractory Partial Onset Seizures
Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
This was an open-label extension study in adolescent and adult (between 12 and 80 years old) participants who had completed their participation in Study E2080-A001-301.
- Trial name
- NCT00448539
- Testing
- Rufinamide
- Where
- 27 sites in United States
- Volunteers
- 286 people
- Sponsor
- Eisai Inc.
Food Effect in Healthy Participants
A Food-Effect Study of E7386 in Healthy Participants
The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of E7386 following single dose administration with and without a meal.
- Trial name
- NCT03996226
- Testing
- E7386
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.