Clinical trials: Restless Leg Syndrome
Restless Legs Syndrome
Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study
Gabapentin enacarbil (GEn; GSK1838262; HORIZANT), at a dose of 600 mg/day, is currently approved in the United States for the treatment of adults with moderate-to-severe primary Restless Legs Syndrome (RLS).
- Trial name
- CONCORD (NCT01668667)
- Testing
- GSK1838262 600 mg, GSK1838262 450 mg, GSK1838262 300 mg
- Where
- 42 sites in United States
- Volunteers
- 501 people
- Sponsor
- XenoPort, Inc.
Restless Legs Syndrome, Neuropathic Pain
Spinal Cord Stimulation for Restless Legs Syndrome
The overall goal of this proposed study is to evaluate the underlying mechanisms of neural control of blood flow in the lower extremities in humans with restless leg syndrome (RLS).
- Trial name
- NCT03539081
- Testing
- Dual-energy X-ray absorptiometry Scan, Laboratory Measurements, Blood Flow Measurement
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Marshall Holland
Restless Legs Syndrome
Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome
The objectives of the Post Market Surveillance (PMS) study are to evaluate the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Rating Scale and Global Clinical…
- Trial name
- NCT00721279
- Testing
- Sifrol® (pramipexole dihydrochloride)
- Where
- 127 sites in Austria
- Volunteers
- 549 people
- Sponsor
- Boehringer Ingelheim
Restless Legs Syndrome
Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS
Safety and Effect of Mirapex(Pramipexole) tablet among Korean Restless Legs Syndrome Patients: An Open-Label, Postmarketing Surveillance Study
- Trial name
- NCT01170091
- Where
- 36 sites in South Korea
- Volunteers
- 651 people
- Sponsor
- Boehringer Ingelheim
Restless Legs Syndrome
Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.
- Trial name
- NCT00991276
- Testing
- pregabalin, pramipexole
- Where
- 41 sites in United States
- Volunteers
- 85 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris 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 Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome
This is a Phase 2, multicenter, open-label, single-arm, optimal dose, long-term follow-up study of monotherapy administration of rotigotine transdermal patch in adolescents with Restless Legs Syndrome (RLS).
- Trial name
- NCT01498120
- Testing
- Rotigotine
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Restless Legs Syndrome
Long-term Study Of Ropinirole In Restless Legs Syndrome
This is an initial placebo-controlled study followed by open treatment evaluating the effectiveness and tolerability of ropinirole long-term in patients with moderate to severe Restless Legs Syndrome.
- Trial name
- NCT00329602
- Testing
- Ropinirole
- Where
- 39 sites in Australia, Czechia and 9 more
- Volunteers
- 404 people
- Sponsor
- GlaxoSmithKline
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
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, Insomnia
Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia
The investigators aim to determine the effect of suvorexant on actigraphically-derived total sleep time in patients with effectively treated restless legs syndrome with persistent insomnia in a two-arm, double-blind, randomized…
- Conditions
- Restless Legs Syndrome, Insomnia, Sleep Disorder
- Trial name
- NCT04706091
- Testing
- Suvorexant
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Massachusetts General Hospital
Restless Legs Syndrome
Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome
The objective of the study was to generate the data necessary to determine the gabapentin exposure produced by 4 dose levels of GEn (600 mg, 1200 mg, 1800 mg, and 2400 mg) or placebo, and the corresponding relief of symptoms in…
- Trial name
- XP081 (NCT01332305)
- Testing
- GEn (XP13512/GSK1838262)
- Where
- United States
- Volunteers
- 217 people
- Sponsor
- XenoPort, Inc.
Restless Legs Syndrome
Bupropion and Restless Legs Syndrome
The purpose of this study is to determine if bupropion will improve the symptoms of restless legs syndrome (RLS).
- Trial name
- NCT00621517
- Testing
- Bupropion
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- East Tennessee State University
Restless Legs Syndrome
XP13512 vs. 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
- NCT00365352
- Testing
- XP13512 600MG, XP13512 1200MG
- Volunteers
- 325 people
- Sponsor
- XenoPort, Inc.
Restless Legs Syndrome
Noninvasive Peripheral Nerve Stimulation for Medication-Refractory Primary RLS (The RESTFUL Study)
Multi-center, prospective double-blind randomized controlled pivotal study of noninvasive peripheral nerve stimulation (NPNS) with the NTX100 Neuromodulation System for patients with medication-refractory moderate-severe primary…
- Trial name
- NCT04874155
- Testing
- NTX100 Neuromodulation System - Active, NTX100 Neuromodulation System - Open-Label
- Where
- 7 sites in United States
- Volunteers
- 133 people
- Sponsor
- Noctrix Health, Inc.
Restless Legs Syndrome
Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome During Opioid Medication Reduction
Prospective open-label single-arm feasibility study assessing the tolerability of opioid medication reduction in conjunction with noninvasive peripheral nerve stimulation (NPNS) for patients taking prescription opioids to treat…
- Trial name
- NCT04698343
- Testing
- Noninvasive Peripheral Nerve Stimulation (NPNS)
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Noctrix Health, Inc.
Restless Legs Syndrome, Iron Deficiency Anemia
Pilot Study: Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of RLS With IDA. (IVOR-IDA)
The purpose of the study is to determine the relative effect size of standard IV and oral iron treatment of RLS with Iron deficiency anemia (IDA) and to determine the time course of treatment response.
- Trial name
- NCT02499354
- Testing
- Ferumoxytol intravenous, Ferrous sulfate
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Auerbach Hematology Oncology Associates P C
Idiopathic Restless Legs Syndrome
Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients
This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.
- Trial name
- RLS (NCT00806026)
- Testing
- pramipexol, Pregabalin
- Where
- 110 sites in United States, Austria and 7 more
- Volunteers
- 731 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
Effect on RLS Symptom Severity After Switching to Neupro® in Patients Who Previously Experienced Augmentation
The objective is to assess the effect of Neupro® on the severity of Restless Leg Syndrome (RLS) symptoms and augmentation in patients with augmentation associated with previous oral dopaminergic therapy.
- Trial name
- AURORA (NCT01386944)
- Where
- 18 sites in Germany
- Volunteers
- 102 people
- Sponsor
- UCB Pharma