Clinical trials: Restless Leg Syndrome
Restless Legs Syndrome
Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome
This was a multicenter, open-label, dose-escalation, Phase 2A study with multiple administrations of the rotigotine transdermal system.
- Trial name
- NCT01495793
- Testing
- Rotigotine
- Where
- 12 sites in United States
- Volunteers
- 42 people
- Sponsor
- UCB BIOSCIENCES, Inc.
RLS
A PK and Safety Evaluation of HORIZANT (Gabapentin Enacarbil) in Adolescents With Moderate-to-Severe Primary RLS
The primary objective is to assess the pharmacokinetics (PK) of gabapentin following the single-dose administration of HORIZANT (Gabapentin Enacarbil) in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe…
- Trial name
- RLS (NCT02633657)
- Testing
- HORIZANT 300 mg
- Where
- 4 sites in United States
- Sponsor
- XenoPort, Inc.
Restless Legs Syndrome, Pregnancy Related
The Effect of Hot Water Application in Pregnant Women With Restless Legs Syndrome: A Randomised Controlled Study
Backgraund and Purpose: The prevalance of restless legs syndrome (RLS) in pregnants varies between 15.4-26.0 percent. As well as pharmacological methods, there are studies reporting that non-pharmacological methods reduce RLS…
- Trial name
- NCT04887103
- Testing
- Hot water application
- Where
- Turkey (Türkiye)
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- TC Erciyes University
Restless Legs Syndrome
Specified Drug Use-Results Survey of Regnite
This study is to investigate the long-term safety and efficacy and the information on the proper use of Regnite® under conditions of daily clinical use.
- Trial name
- NCT01887613
- Testing
- Regnite
- Where
- 7 sites in Japan
- Volunteers
- 1,597 people
- Sponsor
- Astellas Pharma Inc
Restless Legs Syndrome
Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)
Study to evaluate treatment effect of pramipexole on RLS severity as measured by IRLS, CGI-I and RLS-6 and to evaluate the time needed to reach maintenance dose of Pramipexole (PPX)
- Trial name
- NCT02248142
- Testing
- Pramipexole
- Volunteers
- 1,029 people
- Sponsor
- Boehringer Ingelheim
Iron Deficiency, Restless Leg Syndrome
Probiotics in the Treatment of Iron Deficiency in Children With Restless Leg Syndrome
A double-blind randomized controlled trial comparing iron plus vitamin C plus probiotic (lactobacillus plantarum 299) to iron plus vitamin C plus placebo in correcting the iron deficiency in children with Restless leg syndrome…
- Trial name
- NCT01617044
- Testing
- Probiotics
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Children's Hospitals and Clinics of Minnesota
Restless Legs Syndrome
Ropinirole Tablets In Young Patients With Restless Legs Syndrome
This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole titration regimen for this age group.
- Trial name
- NCT00140712
- Testing
- Ropinirole Immediate Release
- Where
- 9 sites in United States, Belgium and 1 more
- Volunteers
- 9 people
- Sponsor
- GlaxoSmithKline
Restless Legs Syndrome, Pregnant
The Effect of Hot and Cold Water Application on Pregnant Women With Restless Leg Syndrome
This study was planned as a randomized controlled study to determine the effect of hot and cold water application on complaints and sleep quality in pregnant women with restless legs syndrome (RLS).
- Conditions
- Restless Legs Syndrome, Pregnant, Sleep Disorder
- Trial name
- RLS (NCT04786314)
- Testing
- Hot Water Application, Cold Water Application
- Where
- Turkey (Türkiye)
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- TC Erciyes University
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
ADHD, Iron-deficiency
Impact of Iron Supplementation Treatment on Brain Iron Concentrations
The goal of the present study is to provide novel data to evaluate brain iron concentration as a mediator of the association between iron supplementation treatment and improvement in symptoms of ADHD and RLS in children…
- Conditions
- ADHD, Iron-deficiency, Restless Legs Syndrome, Periodic Limb Movement Sleep Disorder
- Trial name
- NCT04144790
- Testing
- ferrous sulfate
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Alzheimer's Disease, Dementia
Diagnosis and Natural History Study of Patients With Neurological Conditions
The purpose of this study is to improve understanding of neurological conditions. Patients participating in this study will continue receiving medical care, routine laboratory tests, and diagnostics tests (X-rays, CT-scans, and…
- Conditions
- Alzheimer's Disease, Dementia, Movement Disorder, Multiple System Atrophy
- Trial name
- NCT00001549
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Neuronal Ceroid Lipofuscinosis, Batten's Disease
Neuronal Ceroid Lipofuscinosis and Associated Sleep Abnormalities
Neuronal Ceroid Lipofuscinosis (NCL) also known at Batten's disease is the most common neurodegenerative disorder in children. Families often report the patient has a sleep disturbance.
- Trial name
- NCT01966757
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Nationwide Children's Hospital
Polysomnography, Sleep Apnea Syndromes
Adverse Long-term Consequences of Sleep Disordered Breathing: The Ottawa Hospital (TOH) Sleep Database
The primary purpose of the proposed study is to validate our previously developed predictive model for adults with obstructive sleep apnea using (i) clinical data from multiple large academic centers, (ii) a longer follow-up…
- Conditions
- Polysomnography, Sleep Apnea Syndromes, Risk Factors, Prognosis
- Trial name
- NCT03834792
- Testing
- No intervention but exposure
- Where
- Canada
- Volunteers
- 5,155 people
- Sponsor
- Ottawa Hospital Research Institute
Restless Legs Syndrome
Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome
The survey is conducted to investigate the safety and efficacy of long-term use of BI-Sifrol Tablets in Restless Legs Syndrome (RLS) patients with or without renal dysfunction in routine medical practice.
- Trial name
- NCT01174459
- Where
- 159 sites in Japan
- Volunteers
- 571 people
- Sponsor
- Boehringer Ingelheim
Restless Leg Syndrome, Severe Preeclampsia
Restless Leg Syndrome and Severe Preeclampsia
Restless Leg Syndrome is a common but not well recognized central nervous system disorder. It is more prevalent during pregnancy and, if present before pregnancy, can develop an exacerbation of symptoms.
- Trial name
- NCT01538147
- Where
- Panama
- Volunteers
- 310 people
- Sponsor
- Saint Thomas Hospital, Panama
Restless Legs Syndrome
Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)
The objectives of this Post Marketing Surveillance (PMS) are: Evaluation of the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Syndrome Scale (IRLS) and…
- Trial name
- NCT02248155
- Testing
- Pramipexole
- Volunteers
- 2,644 people
- Sponsor
- Boehringer Ingelheim
RLS
An Extension Study to Evaluate the Efficacy and Safety of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS
The objectives of the trial are to evaluate the long-term efficacy and safety of HORIZANT (Gabapentin Enacarbil) 600 mg daily, for the treatment of RLS in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe…
- Trial name
- RLS (NCT02633683)
- Testing
- HORIZANT 600 mg
- Where
- 11 sites in United States
- Volunteers
- 144 people
- Sponsor
- XenoPort, Inc.
Restless Legs Syndrome
Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)
Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of RLS
- Trial name
- NCT02231918
- Testing
- MIRAPEX® - low, MIRAPEX® - medium, MIRAPEX® - high
- Volunteers
- 26 people
- Sponsor
- Boehringer Ingelheim
Sleep Disorder, Restless Legs Syndrome
Oral Iron Frequency for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder
The purpose of this research study is to see if the level of serum ferritin differs based on how often oral iron (in the form of ferrous sulfate) is given to children with restless leg syndrome/periodic limb movement disorder.
- Conditions
- Sleep Disorder, Restless Legs Syndrome, Periodic Limb Movement Sleep Disorder, Iron-deficiency
- Trial name
- NCT04610827
- Testing
- Ferrous sulfate
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Mayo Clinic
Renal Pelvis Cancer, Restless Legs Syndrome
Gabapentin and Risk of Pancreatic Cancer and Renal Cancer (GPRD)
High doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by spontaneous reports in the Adverse Events…
- Conditions
- Renal Pelvis Cancer, Restless Legs Syndrome, Epilepsy, Neuropathic Pain
- Trial name
- NCT01138124
- Testing
- Gabapentin prescriptions
- Volunteers
- 54,202 people
- Sponsor
- GlaxoSmithKline