Elderly Clinical Trial
Official title:
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. Subjects will be randomized to 1 of 6 doses of E2006 (1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, or 25 mg) or placebo.
The study will have 2 phases, Prerandomization and Randomization. The Prerandomization Phase will last up to 21 days and will consist of a Screening Period (Days -21 to -2) and a Baseline Period (Day -1). Following the Baseline Period, all eligible subjects will be randomized, in a double-blind manner, to receive E2006 or placebo for 15 nights during the Treatment Period (Days 1 to 15), then all subjects will receive placebo, in a single-blind manner, for 2 nights (Days 16 to 17) during the Rebound Insomnia Assessment Period (Days 16 to 18). Subjects will not receive any treatment during the Follow-up Period (Days 19 to 29). All subjects will come to the clinic for screening procedures. During the Screening Period, subjects will complete the Sleep Diary each day. Polysomnographic sleep will be measured during the Screening Period on 2 consecutive nights between Day -9 and Day -3. These 8-hour polysomnograms (PSGs) will start at the median habitual bedtime calculated from responses on the Sleep Diary completed 7 days immediately prior to the first PSG night. Subjects may leave the clinic between the screening/baseline PSG nights. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05531396 -
Agility Training on Physical Performance, Cognitive Function and Brain Activities in Elderly
|
N/A | |
Completed |
NCT03580447 -
The Effect of Citrus Extract on Oxidative Stress
|
N/A | |
Recruiting |
NCT04096547 -
Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
|
||
Completed |
NCT03339791 -
Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial
|
N/A | |
Completed |
NCT03566719 -
Effect of an Exercise Program on Risk of Fall in a Community Dwelling Older Adults
|
N/A | |
Completed |
NCT02138968 -
Clinical and Economic Assessment of a Pre-frail Screening Program
|
N/A | |
Completed |
NCT01368029 -
Safety of Lactobacillus Rhamnosus GG Vs. Placebo in Elderly Subjects Receiving Trivalent Inactivated Influenza Vaccine
|
Phase 1 | |
Not yet recruiting |
NCT01182961 -
The Use of Virtual Reality for the Gait Training of Elderly Fallers
|
N/A | |
Completed |
NCT00961012 -
The Big Squeeze (Lessening the Big Squeeze: The Effect of the Trunk Release on Interface Pressures of Individuals Seated in a High Fowler's Positions)
|
N/A | |
Completed |
NCT01899586 -
Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly
|
N/A | |
Completed |
NCT00748683 -
Development of an Integrated Health Care Environment for Elderly With RFID Technology
|
Phase 0 | |
Completed |
NCT00533065 -
Effects of Donepezil on Deficits Associated With Age-Related Decrease of Growth Hormone
|
N/A | |
Completed |
NCT00798668 -
The Body's Response to Food Intake in Trained, Older Adults
|
N/A | |
Completed |
NCT00324701 -
Telepsychology-Service Delivery for Depressed Elderly Veterans
|
N/A | |
Completed |
NCT00217113 -
An Intervention to Preserve Functional Status and Independence Among Community Dwelling Elderly
|
N/A | |
Completed |
NCT03666793 -
Comprehensive Management of Drug Prescriptions Throughout the Elderly Person's Hospital Care
|
N/A | |
Recruiting |
NCT06030804 -
Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery
|
N/A | |
Recruiting |
NCT05014750 -
Frailty of Elderly With Valvular Heart Disease and the Short Term Adverse Events
|
||
Completed |
NCT05021432 -
Virtual Reality And Task Oriented Circuit Training Among Elderly Population
|
N/A | |
Active, not recruiting |
NCT04132492 -
AGNES - Aging Nephropathy Study, a Prospective Observational Cohort of Chronic Kidney Disease in Elderly Patients
|