Clinical trials: sponsored by Eisai Inc.
Epilepsies, Myoclonic
A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
The primary purpose of the study is to demonstrate that lorcaserin has superior efficacy compared to placebo on percent change in frequency of convulsive seizures per 28 days in participants with Dravet syndrome.
- Trial name
- MOMENTUM 1 (NCT04572243)
- Testing
- Lorcaserin
- Where
- 30 sites in United States, Canada
- Volunteers
- 22 people
- Sponsor
- Eisai Inc.
Osteosarcoma
A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma
This Is a Multicenter, Randomized, Open-Label, Parallel-Group, Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents…
- Trial name
- NCT04154189
- Testing
- Lenvatinib, Ifosfamide, Etoposide
- Where
- 84 sites in United States, Australia and 19 more
- Volunteers
- 81 people
- Sponsor
- Eisai Inc.
Epilepsy
Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy
The purpose of this study is to evaluate the pharmacokinetics (PK) of perampanel during the Maintenance Period of the Core Study following oral suspension administration given as an adjunctive therapy in pediatric participants…
- Trial name
- NCT02914314
- Testing
- perampanel
- Where
- 18 sites in United States, Latvia
- Volunteers
- 26 people
- Sponsor
- Eisai Inc.
Recurrent and Refractory Solid Tumors
Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors
Phase 1 of this study, utilizing a rolling 6 design, will be conducted to determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), and to describe the toxicities of lenvatinib administered in combination with…
- Trial name
- NCT03245151
- Testing
- Lenvatinib, Everolimus
- Where
- 50 sites in United States, Canada
- Volunteers
- 64 people
- Sponsor
- Eisai Inc.
Partial-Onset or Primary Generalized Tonic-Clonic Seizures
Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures
This is an open-label, multicenter study with an Extension Phase to evaluate the safety and tolerability of perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to less than [<] 12 years) with…
- Trial name
- NCT02849626
- Testing
- Perampanel
- Where
- 91 sites in United States, Belgium and 10 more
- Volunteers
- 180 people
- Sponsor
- Eisai Inc.
Relapsed/Refractory Rhabdomyosarcoma, Non-rhabdomyosarcoma Soft Tissue Sarcoma
Study to Assess Safety and Preliminary Activity of Eribulin Mesylate in Pediatric Participants With Relapsed/Refractory Rhabdomyosarcoma (RMS), Non-rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) and Ewing Sarcoma (EWS)
This study will be conducted as an assessment of the safety and preliminary activity of eribulin mesylate in pediatric participants with relapsed/refractory rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma…
- Conditions
- Relapsed/Refractory Rhabdomyosarcoma, Non-rhabdomyosarcoma Soft Tissue Sarcoma, Ewing Sarcoma
- Trial name
- NCT03441360
- Testing
- Eribulin mesylate
- Where
- 41 sites in United States
- Volunteers
- 23 people
- Sponsor
- 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.
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.
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.
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.
Down Syndrome
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (HCl) (Aricept) In Treating Cognitive Dysfunction Exhibited By Children With Down Syndrome
The purpose of this study is to determine whether donepezil HCl is effective and safe in improving cognitive dysfunction exhibited by children and adolescents with Down syndrome (DS).
- Trial name
- NCT00570128
- Testing
- Donepezil HCl
- Where
- 31 sites in United States
- Volunteers
- 129 people
- Sponsor
- Eisai Inc.
Down Syndrome
Evaluating The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled Trial
The purpose of this study is to determine the safety of donepezil hydrochloride (Aricept) in children with Down syndrome who have finished the preceding 10-week, double-blind study of donepezil hydrochloride.
- Trial name
- NCT00675025
- Testing
- Donepezil hydrochloride (Aricept)
- Where
- 31 sites in United States
- Volunteers
- 117 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.
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.
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.
Lennox-Gastaut Syndrome
Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs
This study was designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK) of rufinamide on Lennox-Gastaut Syndrome (LGS) inadequately controlled in pediatric participants already taking other anti-epileptic…
- Trial name
- NCT01405053
- Testing
- Rufinamide, Any other approved Antiepileptic Drug
- Where
- 47 sites in United States, Canada and 5 more
- Volunteers
- 37 people
- Sponsor
- Eisai Inc.
Epilepsy
A Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics in Adolescents
This study is designed to investigate the short- and long-term effects of perampanel on cognition, growth, and development in adolescents.
- Trial name
- NCT01161524
- Testing
- Perampanel
- Where
- 37 sites in United States, Australia and 9 more
- Volunteers
- 133 people
- Sponsor
- Eisai Inc.