search
Back to results

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

Primary Purpose

Restless Legs Syndrome

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Pramipexole
Placebo
Sponsored by
Mauro Manconi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Restless Legs Syndrome focused on measuring Restless legs syndrome

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Neurocenter of Southern Switzerland
  • Department of Neurology, Inselspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pramipexole

Placebo

Arm Description

Pramipexole, 0.25 mg, daily for 4 weeks

Placebo, daily for 4 weeks

Outcomes

Primary Outcome Measures

Change in heart rate activations during sleep from baseline to 4 weeks
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
Baroreflex sensitivity and baroreflex gain derived from tilt table tes
Change in blood serum markers from baseline to 4 weeks
Highly-sensitive C reactive protein (hsCRP), lipoprotein-associated phospholipase A2 (lP-PLA2), and oxidised low density lipoprotein (oxLDL)

Full Information

First Posted
December 23, 2013
Last Updated
January 23, 2017
Sponsor
Mauro Manconi
Collaborators
Insel Gruppe AG, University Hospital Bern, Cardiocentro Ticino
search

1. Study Identification

Unique Protocol Identification Number
NCT02025608
Brief Title
Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome
Acronym
AUTOREST
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mauro Manconi
Collaborators
Insel Gruppe AG, University Hospital Bern, Cardiocentro Ticino

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome
Keywords
Restless legs syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pramipexole
Arm Type
Experimental
Arm Description
Pramipexole, 0.25 mg, daily for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Pramipexole
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in heart rate activations during sleep from baseline to 4 weeks
Description
Number and amplitude of periodic leg movements during sleep (PLMS) and non-PLMS related heart rate activations during stable nocturnal sleep
Time Frame
Baseline, Week 4
Secondary Outcome Measure Information:
Title
Change in baroreflex from baseline to 4 weeks
Description
Baroreflex sensitivity and baroreflex gain derived from tilt table tes
Time Frame
Baseline, Week 4
Title
Change in blood serum markers from baseline to 4 weeks
Description
Highly-sensitive C reactive protein (hsCRP), lipoprotein-associated phospholipase A2 (lP-PLA2), and oxidised low density lipoprotein (oxLDL)
Time Frame
Baseline, Week 4
Other Pre-specified Outcome Measures:
Title
Change in chemoreflexes from baseline to 4 weeks
Description
Peripheral and central chemoreflex sensitivity derived from carbon dioxide (CO2) rebreathing test
Time Frame
Baseline, Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Manconi, PhD, MD
Organizational Affiliation
Neurocenter of Southern Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claudio L.A. Bassetti, MD
Organizational Affiliation
Department of Neurology, Inselspital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurocenter of Southern Switzerland
City
Lugano
State/Province
Ticino
ZIP/Postal Code
6903
Country
Switzerland
Facility Name
Department of Neurology, Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome

We'll reach out to this number within 24 hrs