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Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome (AUTOREST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Ospedale Regionale di Lugano
Sponsor:
Collaborators:
University Hospital Inselspital, Berne
Cardiocentro Ticino
Information provided by (Responsible Party):
Mauro Manconi, Ospedale Regionale di Lugano
ClinicalTrials.gov Identifier:
NCT02025608
First received: December 23, 2013
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Restless Legs Syndrome
Drug: Pramipexole
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ospedale Regionale di Lugano:

Primary Outcome Measures:
  • Change in heart rate activations during sleep from baseline to 4 weeks [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    Number and amplitude of periodic leg movements during sleep (PLMS) and non-PLMS related heart rate activations during stable nocturnal sleep


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)


Other Outcome Measures:
  • Change in chemoreflexes from baseline to 4 weeks [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    Peripheral and central chemoreflex sensitivity derived from carbon dioxide (CO2) rebreathing test


Estimated Enrollment: 50
Study Start Date: December 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pramipexole
Pramipexole, 0.25 mg, daily for 4 weeks
Drug: Pramipexole
Placebo Comparator: Placebo
Placebo, daily for 4 weeks
Drug: Placebo

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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

Contacts
Contact: Mauro Manconi, PhD, MD +41 91 811 ext 6825 mauro.manconi@eoc.ch
Contact: Stephany Fulda, PhD +41 91 811 ext 6962 stephany.fulda@gmail.com

Locations
Switzerland
Neurocenter of Southern Switzerland Recruiting
Lugano, Ticino, Switzerland, 6903
Contact: Stephany Fulda, PhD    +41 91 811 ext 6962    stephany.fulda@gmail.com   
Principal Investigator: Mauro Manconi, PhD, MD         
Sub-Investigator: Stephany Fulda, PhD         
Sub-Investigator: Angelo Auricchio, MD, PhD         
Department of Neurology, Inselspital Recruiting
Bern, Switzerland, 3010
Contact: Nadja Steiner    +41 31 632 ext 9276    nadja.steiner2@insel.ch   
Sponsors and Collaborators
Mauro Manconi
University Hospital Inselspital, Berne
Cardiocentro Ticino
Investigators
Principal Investigator: Mauro Manconi, PhD, MD Neurocenter of Southern Switzerland
Principal Investigator: Claudio L.A. Bassetti, MD Department of Neurology, Inselspital
  More Information

No publications provided

Responsible Party: Mauro Manconi, Dr. med., Ospedale Regionale di Lugano
ClinicalTrials.gov Identifier: NCT02025608     History of Changes
Other Study ID Numbers: NSI.13.01, 320030_144007
Study First Received: December 23, 2013
Last Updated: October 15, 2014
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Keywords provided by Ospedale Regionale di Lugano:
Restless legs syndrome

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Syndrome
Disease
Dyskinesias
Dyssomnias
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Parasomnias
Pathologic Processes
Psychomotor Disorders
Signs and Symptoms
Sleep Disorders
Sleep Disorders, Intrinsic
Pramipexole
Anti-Dyskinesia Agents
Antioxidants
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014