Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome (AUTOREST)
Verified October 2014 by Ospedale Regionale di Lugano
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
Mauro Manconi, Ospedale Regionale di Lugano
First received: December 23, 2013
Last updated: October 15, 2014
Last verified: October 2014
The purpose of this study is to explore whether patients with restless legs syndrome (RLS) differ from healthy subjects in daytime and night time autonomic function and cardiovascular risk markers and whether 4 week treatment with pramipexole affects autonomic function and cardiovascular risk markers in patients with RLS.
Restless Legs Syndrome
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
||Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome: AUTOREST, a Case-control Study and a Randomized, Double-blind, Placebo-controlled, Parallel-group, 4-week, Multicenter Study of 0.25mg Pramipexole vs. Placebo in Patients With RLS
Primary Outcome Measures:
Secondary Outcome Measures:
- Change in baroreflex from baseline to 4 weeks [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
Baroreflex sensitivity and baroreflex gain derived from tilt table tes
- Change in blood serum markers from baseline to 4 weeks [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
Highly-sensitive C reactive protein (hsCRP), lipoprotein-associated phospholipase A2 (lP-PLA2), and oxidised low density lipoprotein (oxLDL)
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2015 (Final data collection date for primary outcome measure)
Pramipexole, 0.25 mg, daily for 4 weeks
Placebo Comparator: Placebo
Placebo, daily for 4 weeks
|Ages Eligible for Study:
||30 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Inclusion Criteria (all participants):
- Willingness to participate and written informed consent
- Aged 30 to 65 years at the time of screening
- Body mass index (BMI) ≤ 30
- Unremarkable neurological and physical examination
- Unremarkable standard blood parameter according to local reference values
Additional Inclusion Criteria for Restless Legs Syndrome (RLS) Patients:
- RLS according to current standard international criteria
- RLS symptoms ≥ 2 times per week for ≥ 1 year and during the past 12 months.
- Either current international RLS severity scale (IRLS) ≥ 15 or current IRLS ≥ 10 and RLS symptoms ≥ 4 times per week during the past 3 months.
Exclusion Criteria (all participants):
- Pregnancy, or breast feeding at time of screening.
- Recent anaesthesia (last 3 months).
- Sleep related breathing disorders during nocturnal polysomnography:
- Current history of psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
- Life time history of any diagnosis of, medication or intervention for cardiovascular diseases.
- Current chronic treatment that may affect autonomic function.
- Any significant neurological disease or diagnosed metabolic diseases that may affect cardiovascular function and/or increase cardiovascular risk.
- Any unstable medical condition.
- Smoking > 5 cigarettes per day during the last 2 years.
- Work involving night shifts (22:00 - 06:00 h) during the past 2 years.
- Travel with > 6 time zone differences during the past 6 months.
- Participation in any other study involving investigational or marketed products concomitantly or within 3 months prior to the screening visit.
- Current participation in other clinical trials.
Additional Exclusion Criteria for RLS Patients
- Exposure to dopaminergic drugs > 12 months during life time and/or > 1 week during the past 3 months and/or current or during the past month.
- Exposure to other RLS relevant medication (such as opioids, antiepileptics, clonidine except hypnotics such as benzodiazepines) > 24 months during life time and/or > 1 week during the past 3 months and/or current intake.
- Intake of hypnotics (such as benzodiazepines) during the past month.
- Other significant sleep disorder except symptoms potentially related to RLS such as insomnia and daytime sleepiness.
- Any contraindication or known hypersensitivity to dopaminergic drugs.
Additional Exclusion Criteria for Control Subjects
- Any pharmacological treatment that may affect sleep and/or sleep related movement disorders during the last 3 months.
- Any clinically significant sleep disorders according to the International Classification of Sleep Disorders (ICSD)12.
- Increased daytime sleepiness as indicated by an Epworth Sleepiness Scale (ESS) score > 11.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02025608
|Neurocenter of Southern Switzerland
|Lugano, Ticino, Switzerland, 6903 |
|Contact: Stephany Fulda, PhD +41 91 811 ext 6962 email@example.com |
|Principal Investigator: Mauro Manconi, PhD, MD |
|Sub-Investigator: Stephany Fulda, PhD |
|Sub-Investigator: Angelo Auricchio, MD, PhD |
|Department of Neurology, Inselspital
|Bern, Switzerland, 3010 |
|Contact: Nadja Steiner +41 31 632 ext 9276 firstname.lastname@example.org |
University Hospital Inselspital, Berne
||Mauro Manconi, PhD, MD
||Neurocenter of Southern Switzerland
||Claudio L.A. Bassetti, MD
||Department of Neurology, Inselspital
No publications provided
||Mauro Manconi, Dr. med., Ospedale Regionale di Lugano
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 23, 2013
||October 15, 2014
Keywords provided by Ospedale Regionale di Lugano:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 20, 2014
Restless Legs Syndrome
Nervous System Diseases
Signs and Symptoms
Sleep Disorders, Intrinsic
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs