Clinical trials: Insomnia Disorder
Sleep Initiation and Maintenance Disorders
Safety and Efficacy Study of Ramelteon in Subjects With Chronic Insomnia
The purpose of this study is to determine the safety and efficacy of 4 mg of Ramelteon, once daily (QD), in subjects with chronic insomnia.
- Trial name
- NCT00756002
- Testing
- Ramelteon
- Volunteers
- 259 people
- Sponsor
- Takeda
Healthy
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
This study will examine the next-day residual effects of a nighttime dose of gabapentin 250 mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on simulated driving performance in normal…
- Trial name
- NCT01888497
- Testing
- Gabapentin, Diphenhydramine citrate, Triazolam
- Where
- 4 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Insomnia
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
The purpose of this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.
- Trial name
- NCT00380081
- Testing
- zolpidem tartrate sublingual tablet 3.5mg, zolpidem tartrate sublingual tablet 1.75mg
- Volunteers
- 82 people
- Sponsor
- Transcept Pharmaceuticals
Insomnia, Major Depressive Disorder
The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
The purpose of this study is to investigate exploratorily the effect of ramelteon 8 mg once daily for 8 weeks in the treatment of insomnia patients with depression by using actigraphy.
- Trial name
- NCT02669082
- Testing
- Ramelteon
- Where
- 7 sites in Japan
- Volunteers
- 26 people
- Sponsor
- Takeda
Transient Insomnia
SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia.
The purpose of this study is to investigate the effectiveness, safety and tolerability of a combination drug product (SM-1) containing diphenhydramine, zolpidem and lorazepam, in adult participants who sometimes have difficulty…
- Trial name
- NCT03331042
- Testing
- SM-1, D+Z, D+L
- Where
- 2 sites in United States
- Volunteers
- 85 people
- Sponsor
- Sequential Medicine Ltd
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.
Primary Insomnia
Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia
A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.
- Trial name
- RESTORA 1 (NCT00608985)
- Testing
- almorexant, zolpidem
- Where
- 91 sites in Australia, Austria and 18 more
- Volunteers
- 709 people
- Sponsor
- Midnight Pharma, LLC
Insomnia
A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3)
This study will establish the safety and tolerability of suvorexant (MK-4305) when administered for up to 14 months. Participants will be randomized to receive suvorexant or placebo for a 12-month double-blind (DB) Treatment…
- Trial name
- NCT01021813
- Testing
- Suvorexant
- Volunteers
- 781 people
- Sponsor
- Merck Sharp & Dohme LLC
Primary Insomnia
Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients
This is a randomised, placebo controlled study to evaluate the efficacy of a 3 week treatment period with Circadin® 2 mg in shortening sleep latency in patients with primary insomnia aged 18-80 with melatonin deficiency.
- Trial name
- NCT00397189
- Testing
- Circadin
- Where
- United Kingdom
- Volunteers
- 930 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
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.
Insomnia
Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)
The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries…
- Trial name
- RUBY (NCT00482612)
- Testing
- Esmirtazapine
- Volunteers
- 526 people
- Sponsor
- Merck Sharp & Dohme LLC
Pain, Osteoarthritis, Hip
Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee
This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a once-daily formulation of a strong opioid against placebo in patients, who are suffering from pain due to osteoarthritis of the hip or the knee…
- Conditions
- Pain, Osteoarthritis, Hip, Osteoarthritis, Knee
- Trial name
- NCT00980798
- Testing
- OROS hydromorphone HCl
- Where
- 12 sites in Czechia, Romania and 2 more
- Volunteers
- 288 people
- Sponsor
- Janssen-Cilag International NV
Insomnia, Sleep
Frequen-ZZZ SleepPad Investigational Device POC
The investigators propose to examine the potential effects of the Frequen- ZZZ sleep pad - a noninvasive, unobtrusive appliance that generates a localized low-level electromagnetic field via radiofrequency, and that is used on…
- Conditions
- Insomnia, Sleep, Sleep Disturbance
- Trial name
- NCT05908344
- Testing
- Activated Sleep Pad system (Frequen-ZZZ), Deactivated Sleep Pad system (Frequen-ZZZ)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Kunasan Inc.
Parkinson's Disease
Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease
The objective of this open-label extension is to assess the long-term effect of the 24-hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non-motor symptoms of Parkinson's disease.
- Trial name
- NCT00519532
- Testing
- Rotigotine
- Where
- 21 sites in United States, Australia and 9 more
- Volunteers
- 84 people
- Sponsor
- UCB Pharma
Insomnia
Effects of Suvorexant in Patients With Chronic Obstructive Pulmonary Disease (MK-4305-032)
This study will evaluate the safety, tolerability, and effect of multiple doses of suvorexant (MK-4305) on respiratory function in participants with chronic obstructive pulmonary disease (COPD).
- Trial name
- NCT01293006
- Testing
- suvorexant
- Volunteers
- 25 people
- Sponsor
- Merck Sharp & Dohme LLC
Insomnia Disorder
Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder
This study evaluates the dose response of ACT-541468 on the change of wake after sleep onset (WASO) assessed by polysomnography (PSG) on the first 2 days of each treatment period.
- Trial name
- NCT02841709
- Testing
- ACT-541468
- Where
- 10 sites in United States, Germany
- Volunteers
- 58 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Insomnia
VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia
The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.
- Trial name
- NCT00291187
- Testing
- 20 mg VEC-162, 50 mg VEC-162, 100 mg VEC-162
- Where
- 19 sites in United States
- Volunteers
- 411 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Insomnia
Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2…
- Trial name
- SUNRISE 1 (NCT02783729)
- Testing
- Lemborexant, Zolpidem tartrate
- Where
- 102 sites in United States, Canada and 5 more
- Volunteers
- 1,006 people
- Sponsor
- Eisai Inc.
Insomnia
Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation
The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with alcohol use disorder (AUD) who experience insomnia associated with alcohol cessation, compared to placebo.
- Trial name
- NCT04035200
- Testing
- V117957 tablets
- Where
- 17 sites in United States
- Volunteers
- 114 people
- Sponsor
- Imbrium Therapeutics
Insomnia
Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty
The purpose of this study is to investigate the safety and efficacy of ramelteon (Rozerem) when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia.
- Trial name
- NCT02058992
- Testing
- Ramelteon
- Volunteers
- 3,339 people
- Sponsor
- Takeda