Clinical trials: Primary Insomnia
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
Primary Insomnia
A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)
The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in Japanese participants with primary insomnia.
- Trial name
- NCT00770510
- Testing
- Eszopiclone 1 mg, Eszopiclone 2 mg, Eszopiclone 3 mg
- Where
- 20 sites in Japan
- Volunteers
- 192 people
- Sponsor
- Eisai Co., Ltd.
Insomnia
A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)
The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.
- Trial name
- NCT00506389
- Testing
- Esmirtazapine
- Volunteers
- 419 people
- Sponsor
- Merck Sharp & Dohme LLC
Primary Insomnia
Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients
This is a phase II study. It is conducted using a randomized, double-blind, 3-arm placebo controlled, parallel group design. Eligible patients will be randomized in a 1:1:1 ratio to receive Neu-P11 20 mg, Neu-P11 50 mg or placebo…
- Trial name
- NCT01489969
- Testing
- Neu-P11
- Where
- 9 sites in United States
- Volunteers
- 137 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Chronic Primary Insomnia
Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia
A 2-night polysomnography / 5-way cross-over study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in elderly subjects with primary insomnia.
- Trial name
- NCT00606593
- Where
- 21 sites in United States
- Volunteers
- 112 people
- Sponsor
- Midnight Pharma, LLC
Sleep Initiation and Maintenance Disorders, Mental Disorders
Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)
This trial is a 26-week, open label extension trial to investigate safety and explore efficacy of esmertazapine in participants with insomnia who completed protocol 21106/P05701/MK-8265-002 (NCT00631657).
- Conditions
- Sleep Initiation and Maintenance Disorders, Mental Disorders, Dyssomnias, Sleep Disorders
- Trial name
- NCT00750919
- Testing
- esmirtazapine
- Volunteers
- 184 people
- Sponsor
- Merck Sharp & Dohme LLC
Primary Insomnia, Secondary Insomnia
An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia
The purpose of this study is to compare an investigational drug (LY2624803) with placebo and with zolpidem in the treatment of outpatients with chronic insomnia.
- Trial name
- SLUMBER (NCT00784875)
- Testing
- LY2624803, zolpidem
- Where
- 49 sites in United States
- Volunteers
- 643 people
- Sponsor
- Eli Lilly and Company
Primary Insomnia
Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)
A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.
- Trial name
- NCT00792298
- Testing
- Suvorexant
- Volunteers
- 254 people
- Sponsor
- Merck Sharp & Dohme LLC
Insomnia, Sleep Initiation and Maintenance Disorders
Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709)
This study was conducted to investigate the efficacy of treatment with Org 50081 (Esmirtazapine) compared to placebo in elderly participants with chronic primary insomnia.
- Conditions
- Insomnia, Sleep Initiation and Maintenance Disorders, Mental Disorders, Dyssomnias
- Trial name
- NCT00561821
- Testing
- Esmirtazapine
- Volunteers
- 538 people
- Sponsor
- Merck Sharp & Dohme LLC
Primary Insomnia
Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study B (MK-4305-029)
This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time…
- Trial name
- NCT01097629
- Testing
- Suvorexant High Dose (HD), Suvorexant Low Dose (LD)
- Volunteers
- 1,020 people
- Sponsor
- Merck Sharp & Dohme LLC
Sleep Disorder, Primary Insomnia
Study of Sleep-maintenance Activity of 3 Doses of SKP-1041
SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is currently available as Sonata as well as several generic formulations. Sonata and its generics induce sleep soon after ingestion.
- Trial name
- NCT00878553
- Testing
- SKP-1041 (experimental formulation of zaleplon)
- Volunteers
- 67 people
- Sponsor
- Somnus Therapeutics, Inc.
Insomnia
A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.
- Trial name
- NCT00770692
- Testing
- Eszopiclone 1 mg- Elderly, Eszopiclone 2 mg- Elderly, Eszopiclone 3 mg- Non-elderly
- Where
- 34 sites in Japan
- Volunteers
- 369 people
- Sponsor
- Eisai Co., Ltd.
Primary Insomnia
Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)
This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time…
- Trial name
- NCT01097616
- Testing
- Suvorexant High Dose (HD), Suvorexant Low Dose (LD)
- Volunteers
- 1,023 people
- Sponsor
- Merck Sharp & Dohme LLC
Insomnia, Migraine
Treatment of Insomnia in Migraineurs
It is hypothesized that treating insomnia in migraineurs, many of whom also have tension headaches, prolongs total sleep time to the extent that it decreases overall headache frequency.
- Trial name
- NCT00812214
- Testing
- eszopiclone
- Volunteers
- 113 people
- Sponsor
- MedVadis Research Corporation
Primary Insomnia
VEC-162 Study in Adult Patients With Primary Insomnia
The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind treatment period of VEC-162 as compared to placebo in male and female patients with primary insomnia.
- Trial name
- NCT00548340
- Testing
- VEC-162 20 mg, VEC-162 50 mg
- Where
- 35 sites in United States
- Volunteers
- 322 people
- Sponsor
- Vanda Pharmaceuticals
Sleep Initiation and Maintenance Disorder; Elderly, Mental Disorder
A Long-Term Safety Study of Org 50081 (Esmirtazapine) in Elderly Outpatients With Chronic Primary Insomnia (176005/P05697/MK-8265-001)
The current study is a 52-week safety study in elderly outpatients with chronic primary insomnia randomized to treatment with 1.5 mg or 3.0 mg of esmirtazapine (Org 50081, SCH 900265, MK-8265) to investigate the safety and…
- Conditions
- Sleep Initiation and Maintenance Disorder; Elderly, Mental Disorder, Dyssomnias, Sleep Disorders
- Trial name
- Jade (NCT00561574)
- Testing
- Esmirtazapine
- Volunteers
- 259 people
- Sponsor
- Merck Sharp & Dohme LLC