Clinical trials: Parasomnias
Restless Legs Syndrome (RLS)
A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
The objective of this study was to assess the efficacy of once-daily oral administration of gabapentin enacarbil versus placebo, based on the change in International Restless Legs Syndrome Rating Scale (IRLS) score in…
- Trial name
- NCT03053427
- Testing
- Gabapentin enacarbil
- Where
- 46 sites in Japan
- Volunteers
- 375 people
- Sponsor
- Astellas Pharma Inc
Restless Legs Syndrome
Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food
This study in RLS patients is designed to assess the affect food has on the absorption, distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted state and other patients following a high-fat…
- Trial name
- NCT00419692
- Testing
- Ropinirole
- Where
- 2 sites in Germany, South Africa
- Volunteers
- 32 people
- Sponsor
- GlaxoSmithKline
Restless Legs Syndrome
XP13512 (GSK1838262) Versus Placebo in Patients With Restless Legs Syndrome.
The primary objective of this trial is to assess the efficacy of XP13512 taken once daily compared to placebo for the treatment of patients suffering from Restless Legs Syndrome (RLS).
- Trial name
- NCT00298623
- Testing
- XP13512 (GSK1838262)
- Volunteers
- 222 people
- Sponsor
- XenoPort, Inc.
Idiopathic Restless Legs Syndrome
Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise
This non-interventional observational study is designed to gain data for Neupro® in restless legs syndrome (RLS) under real life conditions in line with the summary of product characteristics (SmPC) related to effectiveness…
- Trial name
- RLS-Practise (NCT01113710)
- Testing
- Neupro®
- Where
- 80 sites in Germany
- Volunteers
- 687 people
- Sponsor
- UCB Pharma
Restless Legs Syndrome
Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)
This is a multi-center, open-label extension trial conducted at the same European sites that participated in trial SP 709 (NCT00243217).
- Trial name
- NCT00498186
- Testing
- Rotigotine
- Where
- 24 sites in Austria, Germany and 1 more
- Volunteers
- 295 people
- Sponsor
- UCB Pharma
Restless Legs Syndrome (RLS)
Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS
This will be a Phase III, double blinded, multi-center, randomized, placebo-controlled study. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5.
- Trial name
- NCT02397057
- Testing
- Injectafer
- Where
- 19 sites in United States
- Volunteers
- 209 people
- Sponsor
- American Regent, Inc.
Restless Legs Syndrome, Moderate to Severe Idiopathic Restless Legs Syndrome (RLS)
The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome
Ropinirole has shown to improve mood in depressed patients as well as to improve the symptoms of Restless Legs Syndrome. Up to 40% of RLS patients suffer from mild depression, therefore it would be important for decisions no…
- Trial name
- NCT00357097
- Testing
- Ropinirole
- Where
- 50 sites in Germany
- Volunteers
- 240 people
- Sponsor
- GlaxoSmithKline
Sleep Bruxism
Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity
The overall objective of the clinical investigation is to evaluate whether the use of the AesyBite Active reduces the bruxism activity.
- Trial name
- NCT06153810
- Testing
- Biofeedback stimulation
- Where
- Italy
- Volunteers
- 26 people
- Sponsor
- Aesyra SA
Restless Legs Syndrome
A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS
The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with levodopa in the treatment of patients with RLS.
- Trial name
- NCT00625547
- Testing
- cabergoline, levodopa
- Where
- 50 sites in Austria, Germany and 2 more
- Volunteers
- 361 people
- Sponsor
- Pfizer
Adult Nocturnal Enuresis, Urinary Incontinence (UI)
This Study Will Collect Clinical and Patient Reported Experience Data From Participants Requiring Urine Output Management Overnight in the Home Setting.
This post-market study will assess the performance of and user experience with the PureWick™ System in a home setting. The study will also observe safety of the study device and collect information from participants about their…
- Trial name
- PUREST (NCT06666426)
- Testing
- PureWick System, Hollister Female Urinary Pouch External Collection Device
- Where
- 15 sites in United States
- Volunteers
- 171 people
- Sponsor
- C. R. Bard
Restless Legs Syndrome
Clinical Evaluation of Ropinirole IR (Immediate Release) Tablets in Patients Who Are Diagnosed With Symptomatic Restless Legs Syndrome (RLS) Associated With Chronic Kidney Disease (CKD) Managed With Haemodialysis (Including Haemofiltration and Haemodiafiltration)
This is a multicenter, placebo controlled, parallel group, double-blind, randomized comparison study to evaluate the efficacy and safety of ropinirole IR tablets orally administered for 12 weeks in patients with symptomatic…
- Trial name
- NCT00996944
- Testing
- Ropinirole immediate release (IR)
- Where
- 19 sites in Japan
- Volunteers
- 34 people
- Sponsor
- GlaxoSmithKline
Restless Legs Syndrome
IV Iron Treatment of Restless Legs Syndrome
The purpose of this study is to to establish proof-of-concept for efficacy of iron isomaltoside 1000 in subjects with Restless Legs Syndrome. The study is a randomised, comparative, double-blind study with a 3 months extension.
- Trial name
- NCT02484768
- Testing
- Iron isomaltoside 1000, Sodium Chloride 0.9%
- Sponsor
- Pharmacosmos A/S
Short-term Insomnia
Pilot Study of a Combination Drug Product for Treatment of Short-term Insomnia
The purpose of this study is to evaluate the effect of a combination drug product containing diphenhydramine, zolpidem and lorazepam on total sleep time.
- Trial name
- NCT02671760
- Testing
- SM-1, Comparator
- Volunteers
- 39 people
- Sponsor
- Sequential Medicine Ltd
Restless Legs Syndrome
The Effects of Aplindore on the Treatment of Signs and Symptoms of Restless Legs Syndrome
The purpose of this study is to assess the efficacy and tolerability of single doses of aplindore compared to placebo in RLS. Patients will be required to spend 5-8 nights in a sleep laboratory.
- Trial name
- NCT00626418
- Testing
- Aplindore
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Ligand Pharmaceuticals
Restless Legs Syndrome
A Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
The objective of this trial is to demonstrate that rotigotine (SPM 936) is effective in subjects with idiopathic RLS based on the PLMI (Periodic Limb Movements Index)(PLMs/total time in bed) as measured by polysomnography (PSG).
- Trial name
- NCT00275236
- Testing
- Rotigotine
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- UCB Pharma
Sleep Initiation and Maintenance Disorders
Efficacy and Safety of Volinanserin on Sleep Maintenance Insomnia - Polysomnographic Study
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
- NOCTURNE907 (NCT00464243)
- Testing
- volinanserin
- Where
- 7 sites in United States, Australia and 5 more
- Volunteers
- 604 people
- Sponsor
- Sanofi
Restless Legs Syndrome
A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause
The purpose of this study is to demonstrate the efficacy of rotigotine against placebo in adolescent subjects with idiopathic Restless Legs Syndrome (RLS) over a 12-week maintenance period and to investigate the safety and…
- Trial name
- NCT03728933
- Testing
- Rotigotine 1 milligram/24 hours, Rotigotine 2 milligram/24 hours
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- UCB Biopharma SRL
Restless Legs Syndrome
Iron Sucrose In The Treatment of Restless Legs Syndrome: Safety of Three Dose Regimens as Evaluated by Clinical Assessments
Non-randomized open label Phase II clinical trial in which subjects meeting criteria for RLS were assigned to 1 of 3 treatment cohorts.
- Trial name
- NCT00895232
- Testing
- Cohort I, Cohort II, Cohort III
- Volunteers
- 21 people
- Sponsor
- American Regent, Inc.
Sleep Disturbance, Sleep Quality
A Exploratory Study of NatureU Sweet Dream on Sleep Outcomes
This was a single-center, open-label, exploratory self-controlled study evaluating NatureU Sweet Dream on sleep outcomes in adults with mild to moderate sleep disturbance.
- Trial name
- NUSD (NCT07600528)
- Testing
- NatureU Sweet Dream, Commercially Available Melatonin Product
- Where
- China
- Volunteers
- 17 people
- Sponsor
- OmniSolutions Laboratory Holdings Limited
Restless Legs Syndrome
Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)
A 12 week clinical trial was conducted in the United States in order to compare pramipexole (Mirapex®) versus placebo for the ability to reduce the symptoms of restless legs syndrome in adult subjects.
- Trial name
- NCT00133198
- Testing
- Pramipexole
- Where
- 44 sites in United States
- Volunteers
- 345 people
- Sponsor
- Boehringer Ingelheim