Clinical trials: Insomnia, Primary
Primary Insomnia
A Study of Gaboxadol in Primary Insomnia
To evaluate the safety and tolerability of gaboxadol in primary insomnia.
- Trial name
- NCT00209846
- Testing
- Gaboxadol
- Where
- Sweden
- Volunteers
- 320 people
- Sponsor
- H. Lundbeck A/S
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.
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 Disorders, Insomnia
Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia
The aim of the study is to confirm the efficacy of eplivanserin 5mg/day on sleep maintenance of patients with primary insomnia using night polysomnography recordings over a 6-week treatment period corresponding to a stabilization…
- Trial name
- EPOCH (NCT00308503)
- Testing
- eplivanserin (SR46349)
- Where
- 3 sites in United States, Australia and 1 more
- Volunteers
- 608 people
- Sponsor
- Sanofi
Primary Insomnia
Twelve Month Study of the Safety of Eszopiclone in Adult Subjects With Insomnia
A six-month study to determine the safety and efficacy with an additional open-label extension to determine the long-term safety of eszopiclone in the treatment of adult subjects with primary insomnia.
- Trial name
- NCT01710631
- Testing
- eszopiclone 3 mg
- Volunteers
- 791 people
- Sponsor
- Sumitomo Pharma America, Inc.
Sleep Initiation and Maintenance Disorders, Insomnia
Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia
This study is designed to find the optimal (best) doses of GW679769 that could be given daily to promote sleep onset and maintain sleep during the night without significant next-day thinking impairment and drowsiness in subjects…
- Trial name
- NCT00280423
- Testing
- GW679769
- Where
- 71 sites in United States, Canada
- Volunteers
- 342 people
- Sponsor
- GlaxoSmithKline
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
Primary Insomnia
6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia
To evaluate the long-term efficacy of eszopiclone administered for up to 6 months in subjects with primary insomnia on subjective sleep measures, compared to placebo.
- Trial name
- NCT00352144
- Testing
- Eszopiclone
- Where
- 58 sites in United States
- Volunteers
- 830 people
- Sponsor
- Sumitomo Pharma America, Inc.
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
Sleep Initiation and Maintenance Disorders
Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia
The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release) 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with primary insomnia and sleep maintenance…
- Trial name
- NCT00630175
- Testing
- zolpidem-MR (modified release), zolpidem (SL800750)
- Where
- 3 sites in United States, Australia and 1 more
- Volunteers
- 113 people
- Sponsor
- Sanofi
Sleep Initiation and Maintenance Disorders, Mental Disorders
A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)
To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081, SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia.
- Conditions
- Sleep Initiation and Maintenance Disorders, Mental Disorders, Dyssomnias, Sleep Disorders
- Trial name
- NCT00631657
- Testing
- Esmirtazapine
- Volunteers
- 460 people
- Sponsor
- Merck Sharp & Dohme LLC
Sleep Initiation and Maintenance Disorders
Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus
The purpose of this study is to assess efficacy and safety of volinanserin in the population of patients complaining of sleep maintenance insomnia.
- Trial name
- SAMS (NCT00464061)
- Testing
- Volinanserin
- Where
- 22 sites in United States, Argentina and 20 more
- Volunteers
- 1,847 people
- Sponsor
- Sanofi
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 Disorders
Sleep Satisfaction and Psychomotor Performance of Adults
Primary Objective: To assess sleep satisfaction before and after Zolpidem CR (Ambien CR) administration Secondary Objective: To assess Psychomotor Performance before and after Zolpidem CR (Ambien CR) administration
- Trial name
- MORFEO CR (NCT01097382)
- Testing
- ZOLPIDEM
- Where
- 6 sites in Argentina
- Volunteers
- 30 people
- Sponsor
- Sanofi
Primary Insomnia
MK0928 Study in Adult Patients With Primary Insomnia (0928-040)(COMPLETED)
A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.
- Trial name
- NCT00266344
- Testing
- MK0928, gaboxadol / Duration of Treatment 3 Weeks
- Volunteers
- 520 people
- Sponsor
- H. Lundbeck A/S
Sleep Initiation and Maintenance Disorders
Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia
The aim of this trial was to assess the efficacy and safety of Eschscholtzia Californica (EC) in treating patients having psycho-physiologic insomnia in a double-blind randomised placebo controlled trial during a 28-day treatment…
- Trial name
- NCT02183233
- Testing
- Eschscholtzia Californica
- Volunteers
- 49 people
- Sponsor
- Boehringer Ingelheim
Sleep Disorders
Vestipitant 28-day Tolerance Study
This study is a 28-day polysomnographic and subjective assessment of oral Vestipitant 15mg/day for treatment of Primary Insomnia in adults outpatients.
- Trial name
- NCT00992160
- Testing
- GW597599
- Where
- 13 sites in Germany
- Volunteers
- 161 people
- Sponsor
- GlaxoSmithKline
Bladder Function
Pilot Trial in Sleep Laboratory Setting to Compare the Physiology of Night Time Bladder Function in Subjects With Overactive Bladder (OAB) Versus Subjects That Have Insomnia and Healthy Normal Subjects
This is an observational, physiology pilot study of subjects with overactive bladder, insomnia and normal subjects. No study drug will be given. All subjects will complete a one week sleep diary and a 3-day bladder diary.
- Trial name
- Nocturia Plt 1 (NCT01029015)
- Testing
- cystometry, polysomnography
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Melatonin and Zinc Administration on Cardinal Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
The aim of the study is to investigate the effects of oral melatonin and zinc supplementation on core features in individuals with ME/CFS
- Trial name
- MelatoZincME (NCT05454683)
- Testing
- melatonin plus zinc, isomaltose and magnesium stearate
- Where
- Spain
- Volunteers
- 106 people
- Sponsor
- Laboratorios Viñas, S.A.
Sleep Initiation and Maintenance Disorders
A Study With GW597599 And GR205171: Potential New Drugs For The Treatment Of Primary Insomnia
Patients with Primary Insomnia will be treated with GW597599 and GR205171 to evaluate the efficacy in the sleep difficulties associated with insomnia
- Trial name
- NCT00606697
- Testing
- GR205171, GW597599
- Where
- 10 sites in Germany
- Volunteers
- 51 people
- Sponsor
- GlaxoSmithKline