| 1 |
NCT03337529 |
Recruiting |
Restless Legs Syndrome in Hemodialysis Patients |
|
- Other: Vitamin C
- Other: Placebo
|
Interventional |
Not Applicable |
- Makassed General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Other
|
- change in the international restless legs syndrome (IRLS) rating scale score
- incidence of RLS
- Risk factors
|
25 |
All |
18 Years and older (Adult, Senior) |
NCT03337529 |
10082017 |
|
September 15, 2017 |
January 2018 |
March 2018 |
November 9, 2017 |
November 14, 2017 |
|
- Makassed General Hospital
Beirut, Lebanon
|
| 2 |
NCT03218969 |
Not yet recruiting |
Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist |
- Restless Legs Syndrome
- Augmentation
|
- Drug: Ecopipam
- Drug: Placebo
|
Interventional |
Phase 1
Phase 2 |
- William Ondo, MD
- Restless Legs Syndrome Foundation
- The Methodist Hospital System
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- International RLS Rating scale
- Augmentation severity scale
- 24 hour RLS diary
- Clinical Global Impression
|
10 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03218969 |
Pro#00016705 |
RLS-Ecopipam |
September 30, 2017 |
September 15, 2018 |
October 15, 2018 |
July 17, 2017 |
August 22, 2017 |
|
- Houston Methodist Hospital
Houston, Texas, United States
|
| 3 |
NCT02419014 |
Active, not recruiting |
Cranial Electrotherapy for Military Beneficiaries With Restless Legs Syndrome |
|
- Device: Active CES Device Alpha-Stim®
- Device: Sham Device
|
Interventional |
Not Applicable |
- Tripler Army Medical Center
- University of Virginia
|
U.S. Fed / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in International Restless Legs Syndrome Study Group Rating Scale (IRLS) from baseline and weekly for 8 weeks post intervention
- Qualitative Data Interview
- Change in The Hopkins Restless Legs Syndrome Quality of Life Scale (RLS-QOL) from baseline at 4 and 8 weeks post intervention
- (and 3 more...)
|
48 |
All |
18 Years and older (Adult, Senior) |
NCT02419014 |
52H13 |
CES in RLS |
February 2014 |
February 2017 |
February 2017 |
April 17, 2015 |
July 4, 2016 |
|
- Tripler Army Medical Center
Honolulu, Hawaii, United States
|
| 4 |
NCT03249779 |
Recruiting |
Treatment of RLS/WED Symptoms Through Sensory Counter-stimulation |
- Restless Legs Syndrome
- Willis-Ekbom Disease
|
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Severity of Restless Legs Syndrome/Willis Ekbom Disease (RLS/WED) assessed with the IRLS questionnaire
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT03249779 |
16-005286 |
RLS/WED |
December 2016 |
June 2018 |
June 2018 |
August 15, 2017 |
January 9, 2018 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
| 5 |
NCT02386423 |
Completed |
RESTIFFIC™ Foot Wrap Reduces Moderate to Severe Restless Leg Syndrome |
|
- Device: RESTIFFIC™ Brand Pressure Application System
|
Interventional |
Not Applicable |
- Lake Erie Research Institute
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in International Restless Legs Syndrome Study Rating Scale
- Clinical Global Impression Scale
|
30 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02386423 |
Sorg1 |
RESTIFFIC |
April 2009 |
April 2011 |
November 2011 |
March 11, 2015 |
March 11, 2015 |
|
- Baycity Associated in Podiatry Inc
Erie, Pennsylvania, United States
|
| 6 |
NCT02117076 |
Terminated |
Blinded, Randomized Study of Gabapentin (Neurontin®) and Gabapentin Enacarbil (Horizant™) in Restless Leg Syndrome |
|
- Drug: Gabapentin immediate release
- Drug: Gabapentin enacarbil extended release
|
Interventional |
Phase 4 |
- Theresa Zesiewicz
- University of South Florida
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- International Restless Leg Syndrome Rating Scale (IRLS)
- Restless Leg Syndrome Quality of Life Scale (RLSQoL)
|
5 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02117076 |
RLS and Gabapentin or Horizant |
|
April 2014 |
June 2016 |
|
April 17, 2014 |
June 29, 2016 |
|
- University of South Florida
Tampa, Florida, United States
|
| 7 |
NCT01113710 |
Completed
Has Results |
Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise |
- Idiopathic Restless Legs Syndrome
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Severity of Restless Legs Syndrome (RLS) at Bedtime
- Severity of Restless Legs Syndrome (RLS) During the Night
- Satisfaction With Sleep
- (and 3 more...)
|
687 |
All |
18 Years and older (Adult, Senior) |
NCT01113710 |
SP0948 |
RLS-Practise |
May 2010 |
July 2011 |
July 2011 |
April 30, 2010 |
September 28, 2012 |
September 28, 2012 |
- Abensburg, Germany
- Altenholz, Germany
- Alzenau, Germany
- (and 77 more...)
|
| 8 |
NCT02526277 |
Recruiting |
A Study on the Use of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome |
|
- Device: MMF07 Foot Massager
- Device: Heat Therapy
|
Interventional |
Phase 3 |
- Ariane Park
- MedMassager
- Ohio State University
|
Other |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Single (Investigator)
- Primary Purpose: Treatment
|
- Evaluating severity of RLS symptoms using the International Restless Legs Severity Scale.
- Evaluating changes in quality of life using the Restless Legs Quality of Life Questionnaire.
- Evaluating changes in sleep as measured by the Medical Outcomes Sleep Study scale.
|
40 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02526277 |
2015H0107 |
|
July 2015 |
July 2018 |
|
August 18, 2015 |
September 26, 2017 |
|
- Ohio State University
Columbus, Ohio, United States
|
| 9 |
NCT01192503 |
Terminated |
Safety and Efficacy of Rasagiline in Restless Legs Syndrome |
|
- Drug: rasagiline
- Drug: placebo (sugar pill)
|
Interventional |
Phase 2
Phase 3 |
- University of Virginia
- Teva Neuroscience, Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score from Baseline to Week 12
- Tolerability (ability to complete study on assigned dosage)
- Adverse events
- (and 5 more...)
|
52 |
All |
18 Years and older (Adult, Senior) |
NCT01192503 |
14630 |
RAS-RLS |
September 2010 |
June 2012 |
August 2012 |
September 1, 2010 |
February 11, 2013 |
|
- Advent Research
Pinellas Park, Florida, United States - Medical College of Georgia Movements Disorders Program
Augusta, Georgia, United States - Northwestern University PD and Movement Disorders Center
Chicago, Illinois, United States - (and 5 more...)
|
| 10 |
NCT02633657 |
Withdrawn |
A Pharmacokinetic and Safety Evaluation of HORIZANT (Gabapentin Enacarbil) in Adolescents With Moderate-to-Severe Primary RLS |
|
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Area under the concentration-time curve from the time of dosing to the last measurable concentration (AUC0-tlast).
- Area under the concentration-time curve from the time of dosing extrapolated to infinity (AUCinf)
- Percentage of AUCinf that is extrapolated from time of last measurable concentration to infinity (AUCextr%)
- (and 6 more...)
|
0 |
All |
13 Years to 17 Years (Child) |
NCT02633657 |
XP108 |
RLS |
January 2016 |
July 19, 2017 |
July 19, 2017 |
December 17, 2015 |
November 6, 2017 |
|
- Stanford Sleep Medicine Center
Redwood City, California, United States - Pacific Research Network
Saint Louis, Missouri, United States - SleepMed of South Carolina; SleepMed, Inc.
Columbia, South Carolina, United States - Vanderbilt University School of Medicine
Nashville, Tennessee, United States
|
| 11 |
NCT01675323 |
Completed |
Glutamate, Hyperarousal and Restless Legs Syndrome |
|
|
Observational |
|
- Johns Hopkins University
- National Institutes of Health (NIH)
|
Other / NIH |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- MR Spectroscopy - Glutamate
- MR Spectroscopy - GABA
|
77 |
All |
18 Years and older (Adult, Senior) |
NCT01675323 |
NA_00073951 |
|
August 2012 |
July 2016 |
July 2016 |
August 29, 2012 |
March 1, 2017 |
|
- Johns Hopkins Baview Medical
Baltimore, Maryland, United States - Johns Hopkins Bayview Medical Campus
Baltimore, Maryland, United States
|
| 12 |
NCT02484768 |
Withdrawn |
IV Iron Treatment of Restless Legs Syndrome |
|
- Drug: Iron isomaltoside 1000
- Drug: Sodium Chloride 0.9%
|
Interventional |
Phase 2 |
- Pharmacosmos A/S
- BioStata
- Laboratory Corporation of America
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- To measure the change in RLS symptoms from baseline to week 6 measured by the clinical global impression (CGI) score
- Change in RLS symptoms from baseline to week 4 and month 2 and 3 measured by the CGI score
- Change in RLS symptoms from baseline to week 4 and 6 and month 2 and 3 measured by the International Restless Legs Scale (IRLS)
- (and 2 more...)
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT02484768 |
P-RLS-01 |
|
January 2015 |
February 2015 |
February 2015 |
June 30, 2015 |
June 30, 2015 |
|
|
| 13 |
NCT00530790 |
Completed
Has Results |
Clinical Evaluation of Ropinirole CR-RLS ( SK&F101468)Tablets in Restless Legs Syndrome |
|
- Drug: ropinirole controlled release (CR)-RLS
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Drug Related Adverse Events-On-Therapy
- Haematology Clinical Lab Values Change From Baseline
- Blood Chemistry Clinical Lab Values Change From Baseline
- (and 14 more...)
|
35 |
All |
18 Years to 79 Years (Adult, Senior) |
NCT00530790 |
107846 |
|
August 2007 |
February 2008 |
February 2008 |
September 17, 2007 |
February 28, 2017 |
July 24, 2009 |
- GSK Investigational Site
Fukuoka, Japan - GSK Investigational Site
Fukuoka, Japan - GSK Investigational Site
Fukuoka, Japan - (and 8 more...)
|
| 14 |
NCT03063190 |
Recruiting |
Cholecalciferol Supplementation in Restless Leg Syndrome in Patients With Chronic Kidney Disease |
- Restless Leg Disorder
- Renal Disease Bone
- Renal Disease, End Stage
- (and 3 more...)
|
- Drug: Vitamin D
- Drug: Placebo Oral Tablet
|
Interventional |
Phase 4 |
- University of Sao Paulo General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT03063190 |
RLS vitamin D |
RLS |
March 31, 2017 |
March 31, 2018 |
March 2019 |
February 24, 2017 |
May 17, 2017 |
|
- Hospital das Clinicas
Sao Paulo, SP, Brazil
|
| 15 |
NCT01823354 |
Recruiting |
Executive Dysfunction in Restless Legs Syndrome: Clinical Correlates and Outcome After Therapeutic Management |
|
- Other: Polysomnography
- Other: Clinical Scales
- Other: Assessment of executive functions
- Other: Medical consultation
|
Interventional |
Not Applicable |
- University Hospital, Montpellier
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Comparison of the Verbal fluency test between untreated RLS patients and control subjects
- Change of the Clinical Scales at day 180 (composite criteria)
- Change of the sleep fragmentation at day 180 (composite criteria)
- (and 2 more...)
|
140 |
All |
18 Years to 66 Years (Adult, Senior) |
NCT01823354 |
8964 |
|
November 2012 |
July 2019 |
December 2019 |
April 4, 2013 |
April 2, 2018 |
|
- UH Montpellier
Montpellier, France - UH Nîmes
Nîmes, France
|
| 16 |
NCT01109537 |
Completed |
Altered Brain GABA and Glutamate in Restless Legs Syndrome |
|
|
Observational |
|
- Brigham and Women's Hospital
- GlaxoSmithKline
|
Other / Industry |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Regional GABA and glutamate levels derived from 4T MRS.
|
75 |
All |
18 Years and older (Adult, Senior) |
NCT01109537 |
BWH-2010-12345 |
RLS |
April 2010 |
May 2014 |
May 2014 |
April 23, 2010 |
January 7, 2015 |
|
- Sleep HealthCenters
Brighton, Massachusetts, United States
|
| 17 |
NCT01967303 |
Completed |
Restless Legs Syndrome in Stroke Patients |
- Restless Legs Syndrome
- Stroke
- Transient Ischemic Attack
|
|
Observational |
|
- Rambam Health Care Campus
|
Other |
- Observational Model: Case Control
- Time Perspective: Cross-Sectional
|
- Prevalence of Restless legs syndrome in patients with stroke or Transient ischemic attack vs. prevalence in controls.
|
447 |
All |
18 Years and older (Adult, Senior) |
NCT01967303 |
3186 |
|
January 2008 |
December 2008 |
December 2008 |
October 22, 2013 |
October 22, 2013 |
|
|
| 18 |
NCT02633683 |
Enrolling by invitation |
An Extension Study to Evaluate the Efficacy and Safety of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS |
|
|
Interventional |
Phase 4 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical Global Impression of Improvement (CGI-I) score
|
144 |
All |
13 Years to 17 Years (Child) |
NCT02633683 |
XP110 |
RLS |
January 2016 |
May 2024 |
July 2024 |
December 17, 2015 |
November 6, 2017 |
|
- Stanford Sleep Medicine Center
Redwood City, California, United States - Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, United States - Pacific Research Network
Saint Louis, Missouri, United States - (and 4 more...)
|
| 19 |
NCT00806026 |
Completed
Has Results |
Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients |
- Idiopathic Restless Legs Syndrome
|
- Drug: placebo and pregabalin
- Drug: pramipexol
- Drug: Pregabalin
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Restless Legs Syndrome (RLS) Symptom Severity
- Change From Baseline in the RLS Symptom Severity at Week 12
- Percentage of Participants Responding to Treatment at Week 12
- (and 19 more...)
|
731 |
All |
18 Years and older (Adult, Senior) |
NCT00806026 |
A0081186 |
RLS |
December 2008 |
May 2011 |
May 2011 |
December 10, 2008 |
September 27, 2012 |
September 27, 2012 |
- Pfizer Investigational Site
Birmingham, Alabama, United States - Pfizer Investigational Site
Jasper, Alabama, United States - Pfizer Investigational Site
Tuscaloosa, Alabama, United States - (and 107 more...)
|
| 20 |
NCT01521663 |
Completed |
Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS) |
|
- Drug: IPX159
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale
|
159 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01521663 |
IPX159-B11-02 |
|
November 2011 |
February 2013 |
February 2013 |
January 31, 2012 |
February 1, 2017 |
|
- University of Alabama at Birmingham
Brimingham, Alabama, United States - Preferred Research Partners, Inc.
Little Rock, Arkansas, United States - Scripps Clinic
La Jolla, California, United States - (and 35 more...)
|
| 21 |
NCT01538147 |
Completed |
Restless Leg Syndrome and Severe Preeclampsia |
- Restless Leg Syndrome
- Severe Preeclampsia
|
|
Observational |
|
- Saint Thomas Hospital, Panama
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
|
310 |
Female |
Child, Adult, Senior |
NCT01538147 |
MHST2012-02 |
|
August 1, 2017 |
November 30, 2017 |
December 15, 2017 |
February 23, 2012 |
January 4, 2018 |
|
- Saint Thomas Maternity Hospital
Panama, Panama
|
| 22 |
NCT01861652 |
Withdrawn |
Vasculaire Leg Compression Device for the Treatment of Restless Legs Syndrome - A Prospective Clinical Study |
- Restless Legs Syndrome,
- Restless Legs,
- Ekbom Syndrome
|
- Device: Venous Health Systems Vasculaire Leg Compression Device
|
Interventional |
Not Applicable |
- Walter Reed National Military Medical Center
|
U.S. Fed |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The Restless Legs Syndrome Rating Scale
- The Restless Legs Syndrome-Quality of Life Instrument (RLS-QLI)
- The Epworth Sleepiness Scale (ESS)
- (and 2 more...)
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT01861652 |
388140 |
|
July 2013 |
January 2014 |
|
May 23, 2013 |
June 16, 2015 |
|
- Walter Reed National Military Medical Center
Bethesda, Maryland, United States
|
| 23 |
NCT01931878 |
Completed
Has Results |
Investigation of Efficacy of incobotulinumtoxinA (Xeomin) in Relieving Symptoms of Restless Leg Syndrome. |
|
- Drug: incobotulinumtoxinA
- Drug: Placebo
|
Interventional |
Phase 2 |
- Yale University
- Merz North America, Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Mean Total Restless Leg Syndrome Rating Scale Score
- Number of Patients Whose Patient Global Impression of Change (PGIC) Moderately or Much Improved
|
24 |
All |
18 Years and older (Adult, Senior) |
NCT01931878 |
1206010332 |
|
September 2012 |
August 2015 |
August 2015 |
August 29, 2013 |
March 21, 2016 |
March 21, 2016 |
- Yale Physcian Building
New Haven, Connecticut, United States
|
| 24 |
NCT03053427 |
Active, not recruiting |
A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients |
- Restless Legs Syndrome (RLS)
|
- Drug: Gabapentin enacarbil
- Drug: Placebo
|
Interventional |
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline in IRLS score at Week 13 after dosing
- Change from baseline in IRLS score
- Proportion of responders on Investigator-rated Clinical Global Impression (ICGl) of improvement
- (and 13 more...)
|
375 |
All |
20 Years to 80 Years (Adult, Senior) |
NCT03053427 |
8825-CL-0101 |
|
March 30, 2017 |
September 2018 |
September 2018 |
February 15, 2017 |
April 13, 2018 |
|
- Site JP00025
Nagoya, Aichi, Japan - Site JP00029
Nagoya, Aichi, Japan - Site JP00040
Nagoya, Aichi, Japan - (and 43 more...)
|
| 25 |
NCT01981941 |
Completed |
Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment |
- Restless Legs Syndrome (RLS)
|
- Drug: Gabapentin enacarbil
|
Interventional |
Phase 4 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in International Restless Leg Syndrome (IRLS) rating scale score
- Change in Investigator-rated clinical global impression (ICGI) score
- Change in Patient-related clinical global impression (PCGI) score
- (and 2 more...)
|
19 |
All |
20 Years to 80 Years (Adult, Senior) |
NCT01981941 |
8825-CL-0103 |
|
May 2013 |
May 2015 |
May 2015 |
November 13, 2013 |
February 17, 2017 |
|
- Chubu, Japan
- Chugoku, Japan
- Kansai, Japan
- (and 2 more...)
|
| 26 |
NCT02025608 |
Completed |
Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome |
|
- Drug: Pramipexole
- Drug: Placebo
|
Interventional |
Phase 4 |
- Mauro Manconi
- University Hospital Inselspital, Berne
- Cardiocentro Ticino
- Ospedale Regionale di Lugano
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Other
|
- Change in heart rate activations during sleep from baseline to 4 weeks
- Change in baroreflex from baseline to 4 weeks
- Change in blood serum markers from baseline to 4 weeks
|
20 |
All |
30 Years to 65 Years (Adult) |
NCT02025608 |
NSI.13.01
320030_144007 |
AUTOREST |
December 2013 |
December 31, 2016 |
December 31, 2016 |
January 1, 2014 |
January 24, 2017 |
|
- Neurocenter of Southern Switzerland
Lugano, Ticino, Switzerland - Department of Neurology, Inselspital
Bern, Switzerland
|
| 27 |
NCT01174459 |
Completed
Has Results |
Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Incidence of Drug-related Adverse Events
- Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS)
|
571 |
All |
15 Years and older (Child, Adult, Senior) |
NCT01174459 |
248.678 |
|
August 2010 |
August 2013 |
August 2013 |
August 3, 2010 |
August 29, 2014 |
August 29, 2014 |
- Boehringer Ingelheim Investigational Site 119
Akashi, Japan - Boehringer Ingelheim Investigational Site 52
Akishima, Japan - Boehringer Ingelheim Investigational Site 16
Akita, Japan - (and 156 more...)
|
| 28 |
NCT01494766 |
Completed |
Efficacy of Tyrosine in Restless Legs Syndrome |
- Restless Legs Syndrome (RLS)
|
- Dietary Supplement: L-Tyrosine
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- International RLS Survey Group (IRLSSG20) Score
- Clinical global impression-global improvement (CGI-I) scale
- Medical Outcomes Study - Sleep Scale (MOS-SS)
- Case Report Form
|
5 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT01494766 |
CR-11-146 |
|
January 2012 |
May 2012 |
November 2012 |
December 19, 2011 |
April 27, 2017 |
|
- Seton Family of Hospitals
Austin, Texas, United States
|
| 29 |
NCT01562743 |
Completed
Has Results |
A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome |
- Idiopathic Restless Legs Syndrome
|
|
Interventional |
Phase 2 |
- Otsuka Pharmaceutical Co., Ltd.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
- Augmentation
- Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit
- (and 4 more...)
|
185 |
All |
20 Years to 79 Years (Adult, Senior) |
NCT01562743 |
243-07-004 |
RLS |
August 2008 |
October 2010 |
October 2010 |
March 26, 2012 |
April 23, 2014 |
April 23, 2014 |
|
| 30 |
NCT01569464 |
Completed
Has Results |
Rotigotine Effect on All-day Functioning and Quality of Life in Subjects With Moderate to Severe Restless Legs Syndrome (RLS) |
|
- Drug: Rotigotine
- Other: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline To The End Of The Maintenance Period in International Restless Legs Scale (IRLS) Sum Score
- Change In Average Of Means Of Multiple Suggested Immobilization Test Discomfort Scale (m-SIT-DS) Values Of Each Individual Suggested Immobilization Test (SIT) For The Combination Of Multiple Suggested Immobilization Test (m SIT)
- Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) For The Combination Of Multiple Suggested Immobilization Test (m-SIT)
- (and 13 more...)
|
150 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01569464 |
RL0003 |
RESTORE |
March 2012 |
April 2013 |
April 2013 |
April 3, 2012 |
August 26, 2014 |
August 26, 2014 |
- 006
Birmingham, Alabama, United States - 013
Jasper, Alabama, United States - 021
Gilbert, Arizona, United States - (and 15 more...)
|
| 31 |
NCT02658188 |
Completed |
Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients |
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change from baseline in IRLS score
- Safety assessed by Vital signs
- Safety assessed by Adverse Events
- (and 9 more...)
|
182 |
All |
20 Years to 80 Years (Adult, Senior) |
NCT02658188 |
8825-CL-0005 |
|
December 2007 |
April 2009 |
April 2009 |
January 18, 2016 |
February 4, 2016 |
|
- Chiba, Japan
- Fukuoka, Japan
- Hokkaido, Japan
- (and 7 more...)
|
| 32 |
NCT00373542 |
Completed |
12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome |
- Restless Legs Syndrome (RLS)
- Restless Legs Syndrome
|
|
Interventional |
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 12 Change from baseline in sleep Latency at Week 12.
- Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes.
|
39 |
All |
18 Years to 79 Years (Adult, Senior) |
NCT00373542 |
RRL103660 |
(CR-RLS) |
October 2006 |
June 2007 |
June 2007 |
September 8, 2006 |
October 28, 2016 |
|
- GSK Investigational Site
Jasper, Alabama, United States - GSK Investigational Site
Tuscaloosa, Alabama, United States - GSK Investigational Site
Phoenix, Arizona, United States - (and 42 more...)
|
| 33 |
NCT00949806 |
Completed |
Restless Legs Syndrome Treatment With Botulinum Toxin |
|
- Drug: BNT (intradermal injection)
|
Interventional |
Phase 2 |
- University Hospital, Bordeaux
- IPSEN PHARMA S.A.S
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Efficacy of BNT in the treatment of RLS measured by at least 50% improvement of the RLS severity score as measured by the International Restless Legs Syndrome Severity Scale (IRLSRS) at day 15 following BNT injection
- Efficacy duration (maintenance of at least 50% improvement of the RLS severity on the IRLSRS at week 6, 12, 18 and 24 compared to baseline severity score
- Adverse events of BNT injection
- Clinical Global Impression (CGI) improvement
|
27 |
All |
18 Years and older (Adult, Senior) |
NCT00949806 |
CHUBX 2008/35 |
SOXIS |
August 2009 |
May 2011 |
November 2011 |
July 30, 2009 |
July 19, 2012 |
|
- CHU de Bordeaux
Pessac, France
|
| 34 |
NCT00834327 |
Terminated |
Efficacy and Safety Study of Aplindore in Patients With Restless Legs Syndrome |
|
- Drug: aplindore MR tablets or Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- The change from baseline (Day 1) to final (Day 28) on the International Restless Legs Scale (IRLS).
|
230 |
All |
18 Years and older (Adult, Senior) |
NCT00834327 |
Aplindore-250 |
|
February 2009 |
November 2009 |
December 2009 |
February 3, 2009 |
October 14, 2009 |
|
- HOPE Research Institute
Phoenix, Arizona, United States - Genova Clinical Research
Tuscon, Arizona, United States - Excell Research, Inc.
Oceanside, California, United States - (and 21 more...)
|
| 35 |
NCT00621517 |
Completed
Has Results |
Bupropion and Restless Legs Syndrome |
|
- Drug: Bupropion
- Drug: Placebo
|
Interventional |
Phase 2
Phase 3 |
- East Tennessee State University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale.
- Clinical Global Impression - Improvement Scale
- Ordinal Scale(i.e., 1-8)of Symptom Severity
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT00621517 |
ETSU-07-061f |
|
February 2008 |
July 2009 |
July 2009 |
February 22, 2008 |
April 5, 2012 |
April 5, 2012 |
- East Tennessee State University
Johnson City, Tennessee, United States
|
| 36 |
NCT01061372 |
Withdrawn |
12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects |
|
- Drug: Placebo
- Drug: pregabalin
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Changes from baseline in RLS symptom severity using the International Restless Leg Group Rating Scale (IRLS) total score for efficacy assessment
- The proportion of subjects responding to treatment using the Clinical Global Impression - Improvement (CGI-I) scale for efficacy assessment
- Subjective Sleep Questionnaire (SSQ - Subjective WASO)
- (and 12 more...)
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT01061372 |
A0081184 |
|
May 2010 |
August 2011 |
August 2011 |
February 3, 2010 |
June 29, 2010 |
|
|
| 37 |
NCT00656110 |
Unknown † |
Neuroma Injections to Treat Restless Legs Syndrome - RCT |
|
- Drug: equal parts of 0.5% plain Marcaine and 2% lidocaine mixed with 0.8 mg Depo-medrol/4% absolute alcohol in a total injection volume of 1 ml
- Drug: Normal saline - 1ml
|
Interventional |
Not Applicable |
- Lowcountry Infectious Diseases
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- International Restless Legs Rating Scale
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT00656110 |
LID-RLS-RCT-01
(None) |
|
April 2008 |
November 2009 |
December 2009 |
April 10, 2008 |
March 10, 2009 |
|
- Southeastern Foot Specialists
Charleston, South Carolina, United States
|
| 38 |
NCT00479154 |
Completed
Has Results |
Botulinum Toxin to Treat Restless Legs Syndrome |
|
|
Interventional |
Phase 1
Phase 2 |
- National Institute of Neurological Disorders and Stroke (NINDS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Restless Legs Syndrome Rating Scale
|
6 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT00479154 |
070160
07-N-0160 |
|
May 2007 |
April 2008 |
April 2008 |
May 28, 2007 |
April 26, 2012 |
April 26, 2012 |
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 39 |
NCT02256215 |
Unknown † |
Vitamin D in the Treatment of Primary Restless Legs Syndrome |
|
|
Interventional |
Phase 2
Phase 3 |
- King Abdulaziz University
- King AbdulAziz City for Science and Technology
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change in The International Restless Legs Scale (IRLS) total score
|
106 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02256215 |
RLSD-1234 |
|
December 2015 |
December 2017 |
|
October 3, 2014 |
April 6, 2015 |
|
|
| 40 |
NCT02138357 |
Withdrawn |
Butrans for Treatment of Restless Legs Syndrome |
|
- Drug: buprenorphine transdermal delivery system (BTDS)
- Drug: Placebo for BTDS patch
|
Interventional |
Phase 4 |
- Massachusetts General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The International Restless Legs Scale (IRLS)
- Clinical Global Impression of Improvement
|
0 |
All |
25 Years to 75 Years (Adult, Senior) |
NCT02138357 |
2013D004946 |
Butrans |
December 2014 |
December 2016 |
|
May 14, 2014 |
January 7, 2015 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
| 41 |
NCT03457571 |
Completed |
Clinical Observational Study: IBD Patients With Restless-legs-syndrome and Iron Deficiency Syndrome |
- Inflammatory Bowel Diseases
- Restless Legs Syndrome
- Iron-deficiency
|
|
Observational |
|
- Charite University, Berlin, Germany
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Prevalence of RLS in IBD
- Prevalence of clinically relevant RLS in IBD
|
353 |
All |
18 Years and older (Adult, Senior) |
NCT03457571 |
EA4/132/13 |
|
February 1, 2014 |
February 28, 2015 |
April 30, 2015 |
March 7, 2018 |
March 7, 2018 |
|
|
| 42 |
NCT01245777 |
Completed |
Restless Legs Syndrome With Iron Deficiency or Anaemia in the 3rd Trimester of Pregnancy |
- Restless Leg Syndrome
- Iron Deficiency Anemia
|
- Drug: ferric carboxymaltose
|
Interventional |
Phase 4 |
- University of Zurich
- Vifor Inc.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Primary endpoint: = 50% reduction of RLS symptoms as measured by International Restless Legs Study Group (IRLSS)
- Reduction of Periodic Limb Movements in Sleep (PLMS) ≥50% as measured with actimetry
- Improvement of sleep according to the Pittsburgh Sleep Quality Questionnaire (PSQI)
- (and 4 more...)
|
15 |
Female |
18 Years and older (Adult, Senior) |
NCT01245777 |
ITiRiP-1 |
|
October 2009 |
December 2012 |
December 2012 |
November 22, 2010 |
December 5, 2014 |
|
- Neurocenter of Southern Switzerland, Ospedale Civico
Lugano, Ticino, Switzerland - University Hospital Zurich, Neurology
Zurich, Switzerland
|
| 43 |
NCT00530530 |
Completed |
ASP8825 - Study in Patients With Restless Legs Syndrome |
|
- Drug: ASP8825
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The change of the International Restless Legs Syndrome rating scale score
- Investigator-related Clinical Global Impression of Improvement
- Patient- related Clinical Global Impression of Improvement
- (and 4 more...)
|
474 |
All |
20 Years to 80 Years (Adult, Senior) |
NCT00530530 |
8825-CL-0003 |
|
September 2007 |
January 2009 |
January 2009 |
September 17, 2007 |
October 29, 2014 |
|
- Chugoku, Japan
- Hokkaido, Japan
- Kansai, Japan
- (and 3 more...)
|
| 44 |
NCT00676403 |
Completed
Has Results |
Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients |
|
- Drug: placebo
- Drug: Pregabalin
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6
- Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)
- Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
- (and 17 more...)
|
137 |
All |
18 Years to 65 Years (Adult) |
NCT00676403 |
A0081183 |
|
April 2008 |
January 2009 |
January 2009 |
May 13, 2008 |
July 7, 2010 |
February 4, 2010 |
- Pfizer Investigational Site
Tuscaloosa, Alabama, United States - Pfizer Investigational Site
Little Rock, Arkansas, United States - Pfizer Investigational Site
San Diego, California, United States - (and 22 more...)
|
| 45 |
NCT02248155 |
Completed |
Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS) |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Assessment of RLS symptoms (IRLS) on a 4-point rating scale
- Change from Baseline in WPAI by means of a patient questionnaire
- Number of patients with adverse drug reactions
- (and 3 more...)
|
2644 |
All |
Child, Adult, Senior |
NCT02248155 |
248.618 |
|
April 2006 |
November 2006 |
|
September 25, 2014 |
September 25, 2014 |
|
|
| 46 |
NCT01382901 |
Completed
Has Results |
Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS) |
- Restless Legs Syndrome (RLS)
|
- Drug: Ferric Carboxymaltose (FCM)
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- International Restless Legs Syndrome (IRLS) Total Score
|
45 |
All |
18 Years and older (Adult, Senior) |
NCT01382901 |
1VIT05009 |
|
March 2006 |
July 2007 |
July 2007 |
June 27, 2011 |
February 20, 2018 |
June 27, 2011 |
|
| 47 |
NCT02560766 |
Recruiting |
An Efficacy and Safety Evaluation of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS |
|
- Drug: HORIZANT 300 mg
- Drug: HORIZANT 600 mg
- Drug: Placebo
|
Interventional |
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- the change on the IRLS rating scale from baseline to Week 12
- the proportion of patients who are responders, assessed on the CGI-I scale as "much improved" or "very much improved" (CGI-I rating of 1 or 2, respectively) at Week 12
- IRLS total score, change from baseline to Weeks 4 and 8
- (and 4 more...)
|
132 |
All |
13 Years to 17 Years (Child) |
NCT02560766 |
XP109 |
RLS |
February 2016 |
October 2023 |
October 2023 |
September 25, 2015 |
November 6, 2017 |
|
- Stanford Sleep Medicine Center
Redwood City, California, United States - Xenoport Investigational Site
San Diego, California, United States - Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, United States - (and 5 more...)
|
| 48 |
NCT00996944 |
Terminated
Has Results |
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) |
|
- Drug: Ropinirole immediate release (IR)
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 0 and Week 12
- IRLS Rating Scale Total Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
- IRLS Rating Scale Total Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD)
- (and 16 more...)
|
34 |
All |
18 Years to 79 Years (Adult, Senior) |
NCT00996944 |
113079 |
|
November 2009 |
June 2010 |
June 2010 |
October 16, 2009 |
January 18, 2017 |
June 13, 2011 |
- GSK Investigational Site
Aichi, Japan - GSK Investigational Site
Aichi, Japan - GSK Investigational Site
Chiba, Japan - (and 16 more...)
|
| 49 |
NCT01084551 |
Completed
Has Results |
Study of SPM 962 in Patients With Restless Legs Syndrome (RLS) |
- Idiopathic Restless Legs Syndrome
|
- Drug: SPM 962
- Drug: Placebo of SPM 962
|
Interventional |
Phase 3 |
- Otsuka Pharmaceutical Co., Ltd.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- International Restless Legs Syndrome Rating Scale (IRLS) Total Score
- Clinical Global Impression (CGI) Improvement
- Patient Global Impression (PGI) Improvement
- (and 8 more...)
|
284 |
All |
20 Years to 79 Years (Adult, Senior) |
NCT01084551 |
243-09-001
JapicCTI-101053 |
|
February 2010 |
September 2011 |
September 2011 |
March 10, 2010 |
June 5, 2014 |
June 5, 2014 |
- Chubu Region, Japan
- Chugoku Region, Japan
- Hokkaido Region, Japan
- (and 5 more...)
|
| 50 |
NCT00991276 |
Completed
Has Results |
Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance |
|
- Drug: pregabalin
- Drug: placebo
- Drug: pramipexole
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Wake After Sleep Onset (WASO)
- Periodic Limb Movement Arousal Index (PLMAI)
- Subjective Total Sleep Time (sTST)
- (and 28 more...)
|
85 |
All |
18 Years and older (Adult, Senior) |
NCT00991276 |
A0081185 |
|
December 2009 |
June 2011 |
June 2011 |
October 7, 2009 |
October 8, 2012 |
October 8, 2012 |
- Pfizer Investigational Site
Jasper, Alabama, United States - Pfizer Investigational Site
Phoenix, Arizona, United States - Pfizer Investigational Site
Tucson, Arizona, United States - (and 39 more...)
|
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